Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients (CRUISE 2)
Sponsor
Rockwell Medical Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01322347
Collaborator
(none)
294
40
2
34.1
7.4
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to confirm the safety and efficacy of Soluble Ferric Pyrophosphate (SFP) dialysate solution in maintaining iron delivery for erythropoiesis in anemic adult patients with chronic kidney disease (CKD) receiving hemodialysis. Efficacy will be measured primarily by the change from baseline in hemoglobin (Hgb).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Screening: 2-3 weeks prior to enrollment in Stage 1.
Stage 1 (Run-In): 1-4weeks depending on qualification for Stage 2.
Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.
Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.
Study Design
Study Type:
Interventional
Actual Enrollment
:
294 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
A Randomized, Placebo-Controlled, Phase III Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) in Chronic Kidney Disease Patients Receiving Hemodialysis: The Continuous Replacement Using Iron Soluble Equivalents (CRUISE 2) Study
Study Start Date
:
Apr 1, 2011
Actual Primary Completion Date
:
Jan 1, 2014
Actual Study Completion Date
:
Feb 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Soluble Ferric Pyrophosphate (SFP) in dialysate 11 micrograms (µg) of iron / deciliter (dL) of dialysate. |
Drug: Soluble Ferric Pyrophosphate (SFP)
Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
|
| Placebo Comparator: Standard Dialysate 0 micrograms (µg) of iron / deciliter (dL) of dialysate. |
Device: Standard dialysate
Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean [Hgb measured weekly; up to 48 weeks from date of randomization]
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
- Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin [Hgb measured weekly; up to 48 weeks from date of randomization]
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
Secondary Outcome Measures
- Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis [Up to 48 weeks from date of randomization]
The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
- Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis [Up to 48 weeks from date of randomization]
The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
- Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis [Up to 48 weeks from date of randomization]
The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
- Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion [Up to 48 weeks from date of randomization]
The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
- Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused [Up to 48 weeks from date of randomization]
The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
- Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel [up to 48 weeks from date of randomization]
A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).
- Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) [Up to 48 weeks from date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.
- Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) [Up to 48 weeks from date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
- Change From Baseline to End-of-Treatment (EoT) in Ferritin [Up to 48 weeks from date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin
- Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin [Up to 48 weeks from date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
- Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) [Up to 48 weeks from date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
- Variability of Hemoglobin Concentration: Temporal Trend [up to 48 weeks from date of randomization]
The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
- Variability of Hemoglobin Concentration: Residual Standard Deviation [up to 48 weeks from date of randomization]
The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Stage 1:
Main Inclusion Criteria:
-
Adult subject ≥ 18 years of age undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD) for at least 4 months, and expected to remain on hemodialysis three to four times weekly and be able to complete the duration of the study.
-
Received IV iron therapy between 6 months and 2 weeks prior to enrollment in order to replace iron losses resulting from hemodialysis procedure.
-
Mean Screening Hgb ≥ 9.5 to ≤ 11.5 grams per deciliter (g/dL).
-
Mean Screening Transferrin Saturation (TSAT) ≥ 15% to ≤ 40%.
-
Mean Screening serum ferritin ≥ 200 to ≤ 800 micrograms per liter (µg/L).
-
If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 Units (U)/week, darbepoetin dose ≤ 200 micrograms (µg)/week, or CERA dose ≤ 400 micrograms (µg)/month during the four weeks prior to enrollment.
Main Exclusion Criteria:
-
Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
-
Vascular access for dialysis with femoral catheter or non-tunneled catheter.
-
Received a total of > 800 milligrams (mg) IV iron during the 8 weeks prior to enrollment.
-
If being administered an ESA, route of administration change or ESA dose change > 35% (i.e., [max - min dose]/max dose > 0.35) over the 2 weeks prior to screening.
-
Serum albumin < 3.0 grams per deciliter (g/dL) any time over the 8 weeks prior to enrollment.
-
Red Blood Cell (RBC) or whole blood transfusion within 12 weeks prior to enrollment.
Stage 2:
Main Inclusion Criteria:
-
Patient currently enrolled in the Stage 1 run-in period of study.
-
Undergoing chronic hemodialysis three or four times per week for chronic kidney disease (CKD), and expected to remain on hemodialysis three to four times weekly and be able to complete duration of the study.
-
Mean Hgb ≥ 9.5 to ≤ 11.5 g/dL over the three most recent consecutive every-week measurements prior to randomization.
-
Stable Hgb defined as ≤ 1.0 g/dL difference between the maximum and minimum Hgb values over the 3 weeks immediately prior to randomization.
-
Mean TSAT ≥ 15% to ≤ 40% over the two most recent consecutive every-other-week measurements prior to randomization.
-
Mean serum ferritin ≥ 200 to ≤ 800 µg/L over the two most recent consecutive every-other-week measurements prior to randomization.
-
If being administered epoetin, darbepoetin, or CERA, epoetin dose ≤ 45,000 U/week, darbepoetin dose ≤ 200 µg/week, or CERA dose ≤ 400 µg/month during the four weeks prior to randomization.
Main Exclusion Criteria:
-
Patient has living kidney donor identified or living-donor kidney transplant scheduled. (Note: Patients awaiting deceased-donor transplant need not be excluded.)
-
Vascular access for dialysis with femoral catheter or non-tunneled catheter.
-
Received any amount of IV iron during the 4 weeks prior to randomization.
-
If being administered an (Erythropoietin Stimulating Agent) ESA, change in dose over the 6 weeks immediately prior to randomization.
-
Serum albumin < 3.0 g/dL any time over the 8 weeks prior to randomization.
-
RBC or whole blood transfusion during Stage 1.
Stage 3:
Main Inclusion Criteria:
-
Patient randomized in Stage 2 who has completed the full duration of Stage 2 and less than 4 weeks have elapsed since completion of Stage 2, OR
-
Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for protocol-defined Protocol-Mandated Change in Anemia Management and less than 4 weeks have elapsed since withdrawal from Stage 2, OR
-
Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for Hgb >11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks.
Main Exclusion Criteria:
- Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator | Paragould | Arkansas | United States | 72450 |
| 2 | Investigator | Pine Bluff | Arkansas | United States | 71603 |
| 3 | Investigator | Alhambra | California | United States | 91801 |
| 4 | Investigator | Beverly Hills | California | United States | 90211 |
| 5 | Investigator | Glendale | California | United States | 91204 |
| 6 | Investigator | La Mesa | California | United States | 91942 |
| 7 | Investigator | Long Beach | California | United States | 90807 |
| 8 | Investigator | Lynwood | California | United States | 90262 |
| 9 | Investigator | Paramount | California | United States | 90723 |
| 10 | Investigator | Whittier | California | United States | 90603 |
| 11 | Investigator | Pembroke Pines | Florida | United States | 33025 |
| 12 | Investigator | Augusta | Georgia | United States | 30901 |
| 13 | Investigator | Macon | Georgia | United States | 31217 |
| 14 | Investigator | Meridian | Idaho | United States | 83642 |
| 15 | Investigator | Hines | Illinois | United States | 60141 |
| 16 | Investigator | Rockville | Maryland | United States | 20850 |
| 17 | Investigator | Detroit | Michigan | United States | 48236 |
| 18 | Investigator | Pontiac | Michigan | United States | 48341 |
| 19 | Investigator | Southfield | Michigan | United States | 48034 |
| 20 | Investigator | Eatontown | New Jersey | United States | 07724 |
| 21 | Investigator | Brooklyn | New York | United States | 11212 |
| 22 | Investigator | Fresh Meadows | New York | United States | 11365 |
| 23 | Investigator | Great Neck | New York | United States | 11021 |
| 24 | Investigator | Orchard Park | New York | United States | 14127 |
| 25 | Investigator | The Bronx | New York | United States | 10461 |
| 26 | Investigator | Bethany | Oklahoma | United States | 73008 |
| 27 | Investigator | Bethlehem | Pennsylvania | United States | 18017 |
| 28 | Investigator | Philadelphia | Pennsylvania | United States | 19106 |
| 29 | Investigator | Philadelphia | Pennsylvania | United States | 19144 |
| 30 | Investigator | Nashville | Tennessee | United States | 37205 |
| 31 | Investigator | Nashville | Tennessee | United States | 37232 |
| 32 | Investigator | Arlington | Texas | United States | 76015 |
| 33 | Investigator | Fort Worth | Texas | United States | 76104 |
| 34 | Investigator | Fort Worth | Texas | United States | 76105 |
| 35 | Investigator | Houston | Texas | United States | 77004 |
| 36 | Investigator | Houston | Texas | United States | 77099 |
| 37 | Investigator | San Antonio | Texas | United States | 78229 |
| 38 | Investigator | Fairfax | Virginia | United States | 22033 |
| 39 | Investogator | Edmonton | Alberta | Canada | T6G 2B7 |
| 40 | Investigator | Greenfield Park | Quebec | Canada | J4V 2H1 |
Sponsors and Collaborators
- Rockwell Medical Technologies, Inc.
Investigators
- Study Director: Ray Pratt, MD, Rockwell Medical
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01322347
Other Study ID Numbers:
- RMTI-SFP-5
First Posted:
Mar 24, 2011
Last Update Posted:
Apr 26, 2017
Last Verified:
Apr 1, 2017
Keywords provided by Rockwell Medical Technologies, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Soluble Ferric Pyrophosphate (SFP) in Dialysate | Standard Dialysate (Placebo) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Period Title: Overall Study | ||
| STARTED | 147 | 147 |
| Completed 48 Wks in St 2 | 28 | 22 |
| Comp St 2 Due to ESA/IV Iron Needs | 68 | 90 |
| Enrolled in St 3 | 101 | 113 |
| Completed St 3 | 82 | 86 |
| COMPLETED | 96 | 112 |
| NOT COMPLETED | 51 | 35 |
Baseline Characteristics
| Arm/Group Title | Soluble Ferric Pyrophosphate (SFP) in Dialysate | Standard Dialysate (Placebo) | Total |
|---|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. | Total of all reporting groups |
| Overall Participants | 147 | 147 | 294 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
58.1
(12.68)
|
59.0
(14.38)
|
58.5
(13.54)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
65
44.2%
|
54
36.7%
|
119
40.5%
|
| Male |
82
55.8%
|
93
63.3%
|
175
59.5%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
33
22.4%
|
36
24.5%
|
69
23.5%
|
| Not Hispanic or Latino |
114
77.6%
|
111
75.5%
|
225
76.5%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
0
0%
|
3
2%
|
3
1%
|
| Asian |
8
5.4%
|
4
2.7%
|
12
4.1%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
2
1.4%
|
2
0.7%
|
| Black or African American |
64
43.5%
|
54
36.7%
|
118
40.1%
|
| White |
73
49.7%
|
83
56.5%
|
156
53.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
1.4%
|
1
0.7%
|
3
1%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
128
87.1%
|
123
83.7%
|
251
85.4%
|
| Canada |
19
12.9%
|
24
16.3%
|
43
14.6%
|
| Height (centimeters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeters] |
168.80
(10.238)
|
170.01
(9.944)
|
169.40
(10.093)
|
| Post-dialysis weight (kilograms) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms] |
86.64
(22.270)
|
85.09
(23.474)
|
85.86
(22.857)
|
Outcome Measures
| Title | Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean |
|---|---|
| Description | Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error. |
| Time Frame | Hgb measured weekly; up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Least Squares Mean (Standard Error) [grams per liter] |
-0.5
(1.08)
|
-4.0
(1.09)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate, Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.011 |
| Comments | LS Mean (SE) and p-value are from ANCOVA model with baseline Hgb as covariate. Model also includes indicator variable for baseline ESA dose stratum. | |
| Method | ANCOVA | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference in LS Means between SFP & PBO |
| Estimated Value | 3.6 | |
| Confidence Interval |
(2-Sided) 95% to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.39 |
|
| Estimation Comments | ||
| Title | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis |
|---|---|
| Description | The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| mean pre-dialysis serum iron |
11.634
(3.2506)
|
11.086
(3.0143)
|
| mean post-dialysis serum iron |
31.347
(7.9885)
|
12.247
(4.0720)
|
| serum iron change from pre- to post-dialysis |
19.675
(6.8227)
|
1.194
(3.4709)
|
| Title | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis |
|---|---|
| Description | The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| mean pre-dialysis TSAT (transferrin) |
24.7
(6.67)
|
23.2
(8.35)
|
| mean post-dialysis TSAT (transferrin) |
62.3
(13.32)
|
23.3
(7.80)
|
| pre- to post-dialysis change in TSAT |
37.5
(11.46)
|
0.1
(6.87)
|
| Title | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis |
|---|---|
| Description | The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| mean pre-dialysis UIBC |
30.54
(5.645)
|
32.19
(6.847)
|
| mean post-dialysis UIBC |
17.15
(6.030)
|
34.75
(7.437)
|
| pre- to post-dialysis change in UIBC |
-13.31
(5.024)
|
2.57
(3.345)
|
| Title | Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion |
|---|---|
| Description | The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat: all randomized subjects |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 147 | 147 |
| Number [participants] |
6
4.1%
|
12
8.2%
|
| Title | Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused |
|---|---|
| Description | The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| intent-to-treat: all randomized subjects |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 147 | 147 |
| Number [units of red blood cells or whole blood] |
15
|
29
|
| Title | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel |
|---|---|
| Description | A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT). |
| Time Frame | up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| CHr percentage of change from baseline |
-1.62
(4.402)
|
-2.59
(4.490)
|
| Ferritin percentage of change from baseline |
-11.6
(29.51)
|
-21.7
(68.50)
|
| UIBC percentage of change from baseline |
3.77
(14.717)
|
9.46
(16.537)
|
| Serum Iron percentage of change from baseline |
2.470
(31.3742)
|
-7.313
(27.8687)
|
| Transferrin percentage of change from baseline |
1.318
(9.3574)
|
3.988
(10.6940)
|
| TIBC percentage of change from baseline |
1.87
(9.472)
|
3.48
(10.166)
|
| TSAT percentage of change from baseline |
0.6
(29.69)
|
-10.5
(25.06)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified. |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline UIBC |
30.17
(5.866)
|
30.70
(6.481)
|
| EoT UIBC |
31.03
(6.501)
|
33.24
(7.115)
|
| UIBC Change from Baseline to EoT |
0.92
(4.359)
|
2.56
(4.653)
|
| Baseline Serum Iron |
11.663
(3.7879)
|
11.949
(3.9547)
|
| EoT Serum Iron |
11.438
(3.5804)
|
10.658
(3.3615)
|
| Serum Iron Change from Baseline to EoT |
-0.244
(3.4146)
|
-1.342
(3.3957)
|
| Baseline TIBC |
41.83
(6.184)
|
42.65
(6.942)
|
| EoT TIBC |
42.47
(6.866)
|
43.90
(6.928)
|
| TIBC Change from Baseline to EoT |
0.67
(0.093)
|
1.22
(4.466)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline CHr |
32.57
(2.239)
|
32.54
(1.928)
|
| EoT CHr |
32.01
(2.140)
|
31.69
(2.130)
|
| CHr Change from Baseline to EoT |
-0.56
(0.021)
|
-0.86
(1.480)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Ferritin |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline Ferritin |
513.6
(201.37)
|
479.8
(201.52)
|
| EoT Ferritin |
446.5
(225.33)
|
359.3
(278.61)
|
| Ferritin Change from Baseline to EoT |
-67.1
(164.39)
|
-122.7
(269.70)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline Transferrin |
1.885
(0.3049)
|
1.921
(0.3224)
|
| EoT Transferrin |
1.902
(0.3267)
|
1.987
(0.3366)
|
| Transferrin Change from Baseline to EoT |
0.019
(0.1839)
|
0.066
(0.2138)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) |
| Time Frame | Up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline TSAT |
27.9
(8.25)
|
28.2
(8.58)
|
| EoT TSAT |
27.1
(8.01)
|
24.6
(8.42)
|
| TSAT Change from Baseline to EoT |
-0.9
(7.65)
|
-3.7
(7.33)
|
| Title | Variability of Hemoglobin Concentration: Temporal Trend |
|---|---|
| Description | The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2. |
| Time Frame | up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Mean (Standard Deviation) [grams per liter per week] |
0.023
(0.222)
|
0.003
(0.350)
|
| Title | Variability of Hemoglobin Concentration: Residual Standard Deviation |
|---|---|
| Description | The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2. |
| Time Frame | up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study medication and had at least one post dose hemoglobin measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Mean (Standard Deviation) [grams per liter] |
4.352
(1.501)
|
4.407
(2.031)
|
| Title | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin |
|---|---|
| Description | Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation). |
| Time Frame | Hgb measured weekly; up to 48 weeks from date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured. |
| Arm/Group Title | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 2 Placebo (Standard Dialysate) |
|---|---|---|
| Arm/Group Description | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 48 weeks. | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week for up to 48 weeks. |
| Measure Participants | 142 | 144 |
| Baseline Hemoglobin |
109.6
(6.09)
|
109.3
(6.25)
|
| End-of-Treatment Hemoglobin |
108.7
(13.81)
|
104.9
(13.33)
|
| Mean Change in Hemoglobin from at End-of- |
-0.9
(11.76)
|
-4.5
(11.71)
|
Adverse Events
| Time Frame | In Stage 2, subjects were randomized to placebo or SFP. They were in Stage 2 for up to 48 weeks. Upon completion of Stage 2, subjects could enter the open-label Stage 3 (all received SFP). The maximum total time on study (Stage 2 + Stage 3) was 72 weeks. | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | The number of subjects included in the safety population = 288, which is 6 subjects fewer than the number of subjects randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Six subjects withdrew from Stage 2 prior to study drug exposure. | |||||
| Arm/Group Title | Stage 2 Standard Dialysate (Placebo) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) | |||
| Arm/Group Description | 0 micrograms (µg) of iron / deciliter (dL) of dialysate. Standard dialysate: Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks. | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 2 for up to 48 weeks. | 11 micrograms (µg) of iron / deciliter (dL) of dialysate. Soluble Ferric Pyrophosphate (SFP): Upon completion of Stage 2, patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week in Stage 3 for up to 72 weeks of total study participation (Stage 2 + Stage 3). | |||
All Cause Mortality |
||||||
| Stage 2 Standard Dialysate (Placebo) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Stage 2 Standard Dialysate (Placebo) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 36/145 (24.8%) | 44/143 (30.8%) | 83/214 (38.8%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 3/214 (1.4%) | 3 |
| COAGULOPATHY | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| HAEMORRHAGIC ANAEMIA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| LEUKOCYTOSIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Cardiac disorders | ||||||
| ACUTE MYOCARDIAL INFARCTION | 3/145 (2.1%) | 3 | 0/143 (0%) | 0 | 4/214 (1.9%) | 4 |
| ANGINA PECTORIS | 2/145 (1.4%) | 3 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| ANGINA UNSTABLE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| AORTIC VALVE STENOSIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| ATRIAL FIBRILLATION | 2/145 (1.4%) | 2 | 1/143 (0.7%) | 1 | 8/214 (3.7%) | 8 |
| CARDIAC ARREST | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 4/214 (1.9%) | 4 |
| CARDIAC FAILURE CONGESTIVE | 2/145 (1.4%) | 3 | 4/143 (2.8%) | 5 | 4/214 (1.9%) | 5 |
| CARDIOGENIC SHOCK | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| CARDIOMYOPATHY | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| CARDIO-RESPIRATORY ARREST | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| CORONARY ARTERY DISEASE | 2/145 (1.4%) | 2 | 0/143 (0%) | 0 | 3/214 (1.4%) | 3 |
| MYOCARDIAL INFARCTION | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PALPITATIONS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| SUPRAVENTRICULAR TACHYCARDIA | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| Congenital, familial and genetic disorders | ||||||
| CONGENITAL CYSTIC KIDNEY DISEASE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Endocrine disorders | ||||||
| HYPERPARATHYROIDISM SECONDARY | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| HYPOTHYROIDISM | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| Gastrointestinal disorders | ||||||
| ASCITES | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| COLONIC POLYP | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| CONSTIPATION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| DIABETIC GASTROPARESIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| DIARRHOEA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 3/214 (1.4%) | 3 |
| GASTRIC ULCER | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| GASTRITIS EROSIVE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| GASTROINTESTINAL HAEMORRHAGE | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| INGUINAL HERNIA, OBSTRUCTIVE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| NAUSEA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| PANCREATITIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| PANCREATITIS ACUTE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| PANCREATITIS CHRONIC | 0/145 (0%) | 0 | 1/143 (0.7%) | 2 | 0/214 (0%) | 0 |
| PANCREATITIS RELAPSING | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SMALL INTESTINAL OBSTRUCTION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SMALL INTESTINAL PERFORATION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| UPPER GASTROINTESTINAL HAEMORRHAGE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| VOMITING | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| General disorders | ||||||
| ADVERSE DRUG REACTION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CATHETER SITE HAEMORRHAGE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| CHEST PAIN | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| DEATH | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| MALAISE | 0/145 (0%) | 0 | 1/143 (0.7%) | 2 | 0/214 (0%) | 0 |
| NON-CARDIAC CHEST PAIN | 2/145 (1.4%) | 2 | 2/143 (1.4%) | 2 | 6/214 (2.8%) | 6 |
| PYREXIA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| SUDDEN DEATH | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| BILIARY COLIC | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CHOLELITHIASIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Infections and infestations | ||||||
| APPENDICITIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA SITE INFECTION | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| ARTERIOVENOUS GRAFT SITE INFECTION | 2/145 (1.4%) | 2 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| BACTERAEMIA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| BRONCHITIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| BRONCHOPNEUMONIA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CELLULITIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 4/214 (1.9%) | 4 |
| DEVICE RELATED SEPSIS | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 3/214 (1.4%) | 3 |
| DIABETIC FOOT INFECTION | 0/145 (0%) | 0 | 3/143 (2.1%) | 4 | 2/214 (0.9%) | 2 |
| GANGRENE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 5/214 (2.3%) | 6 |
| GASTROENTERITIS VIRAL | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| INFLUENZA | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| JOINT ABSCESS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| KLEBSIELLA SEPSIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| LOBAR PNEUMONIA | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| NECROTISING FASCIITIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| OSTEOMYELITIS | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 3/214 (1.4%) | 5 |
| PNEUMONIA | 3/145 (2.1%) | 3 | 2/143 (1.4%) | 2 | 4/214 (1.9%) | 5 |
| POSTOPERATIVE WOUND INFECTION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| PSEUDOMONAL BACTERAEMIA | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| PYELONEPHRITIS ACUTE | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SEPSIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| SEPSIS SYNDROME | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SEPTIC SHOCK | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| STAPHYLOCOCCAL BACTERAEMIA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| URINARY TRACT INFECTION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| UROSEPSIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| VIRAL UPPER RESPIRATORY TRACT INFECTION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| Injury, poisoning and procedural complications | ||||||
| ANAEMIA POSTOPERATIVE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| ANKLE FRACTURE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA SITE COMPLICATION | 2/145 (1.4%) | 2 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| ARTERIOVENOUS FISTULA THROMBOSIS | 1/145 (0.7%) | 1 | 3/143 (2.1%) | 3 | 4/214 (1.9%) | 4 |
| ARTERIOVENOUS GRAFT SITE HAEMORRHAGE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| FACIAL BONES FRACTURE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| FALL | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| FEMORAL NECK FRACTURE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| FRACTURE DISPLACEMENT | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 2 |
| GASTROINTESTINAL STOMA COMPLICATION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| INCISION SITE PAIN | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| POSTOPERATIVE ILEUS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| PROCEDURAL HYPOTENSION | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 4/214 (1.9%) | 5 |
| PROCEDURAL NAUSEA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PROCEDURAL PAIN | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 0/214 (0%) | 0 |
| VASCULAR GRAFT COMPLICATION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| VASCULAR GRAFT THROMBOSIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| VASCULAR PSEUDOANEURYSM | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| Investigations | ||||||
| TROPONIN INCREASED | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| Metabolism and nutrition disorders | ||||||
| DIABETIC FOOT | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| DIABETIC KETOACIDOSIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 2 |
| FLUID OVERLOAD | 3/145 (2.1%) | 5 | 3/143 (2.1%) | 3 | 10/214 (4.7%) | 12 |
| HYPERKALAEMIA | 2/145 (1.4%) | 2 | 2/143 (1.4%) | 2 | 7/214 (3.3%) | 9 |
| HYPERVOLAEMIA | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| HYPOGLYCAEMIA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 4/214 (1.9%) | 4 |
| HYPOKALAEMIA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| METABOLIC ACIDOSIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| NEUROGLYCOPENIA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRITIS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CERVICAL SPINAL STENOSIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| INTERVERTEBRAL DISC PROTRUSION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| MUSCULOSKELETAL CHEST PAIN | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| BASAL CELL CARCINOMA | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CARDIAC NEOPLASM UNSPECIFIED | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| COLON CANCER | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| METASTATIC NEOPLASM | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PROSTATE CANCER | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SQUAMOUS CELL CARCINOMA OF SKIN | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| TESTIS CANCER | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| TRANSITIONAL CELL CARCINOMA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Nervous system disorders | ||||||
| CEREBROVASCULAR ACCIDENT | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| HYDROCEPHALUS | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| HYPOXIC-ISCHAEMIC ENCEPHALOPATHY | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| METABOLIC ENCEPHALOPATHY | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| POSTERIOR REVERSIBLE ENCEPHALOPATHY SYNDROME | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| STATUS EPILEPTICUS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SYNCOPE | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| TRANSIENT ISCHAEMIC ATTACK | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| VERTEBROBASILAR INSUFFICIENCY | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| Psychiatric disorders | ||||||
| ANXIETY | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| CONFUSIONAL STATE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| DEPRESSION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| MENTAL STATUS CHANGES | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 4 |
| Renal and urinary disorders | ||||||
| NEPHROLITHIASIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| RENAL CYST HAEMORRHAGE | 2/145 (1.4%) | 2 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| ACUTE PULMONARY OEDEMA | 2/145 (1.4%) | 2 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| ACUTE RESPIRATORY FAILURE | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 3/214 (1.4%) | 3 |
| CHRONIC OBSTRUCTIVE PULMONARY DISEASE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 2/214 (0.9%) | 2 |
| DYSPNOEA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| EPISTAXIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PLEURAL EFFUSION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PULMONARY EMBOLISM | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| PULMONARY OEDEMA | 0/145 (0%) | 0 | 4/143 (2.8%) | 4 | 7/214 (3.3%) | 7 |
| RESPIRATORY DISTRESS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| RESPIRATORY FAILURE | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Skin and subcutaneous tissue disorders | ||||||
| ANGIOEDEMA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| DECUBITUS ULCER | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| SKIN ULCER | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| URTICARIA | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Surgical and medical procedures | ||||||
| CARDIAC ABLATION | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| OBESITY SURGERY | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| REVERSAL OF ILEOJEJUNAL BYPASS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| Vascular disorders | ||||||
| AORTIC DISSECTION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| AORTIC STENOSIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| DEEP VEIN THROMBOSIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| EXSANGUINATION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| FEMORAL ARTERY OCCLUSION | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 0/214 (0%) | 0 |
| HYPERTENSION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| HYPERTENSIVE CRISIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| HYPERTENSIVE EMERGENCY | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
| HYPOTENSION | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 2/214 (0.9%) | 2 |
| MALIGNANT HYPERTENSION | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 2/214 (0.9%) | 2 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 0/214 (0%) | 0 |
| PERIPHERAL VASCULAR DISORDER | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 1/214 (0.5%) | 1 |
| TEMPORAL ARTERITIS | 0/145 (0%) | 0 | 0/143 (0%) | 0 | 1/214 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Stage 2 Standard Dialysate (Placebo) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 93/145 (64.1%) | 89/143 (62.2%) | 179/214 (83.6%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 5/145 (3.4%) | 5 | 3/143 (2.1%) | 3 | 17/214 (7.9%) | 21 |
| Cardiac disorders | ||||||
| ANGINA PECTORIS | 2/145 (1.4%) | 3 | 1/143 (0.7%) | 2 | 11/214 (5.1%) | 13 |
| BRADYCARDIA | 4/145 (2.8%) | 6 | 4/143 (2.8%) | 10 | 7/214 (3.3%) | 15 |
| TACHYCARDIA | 4/145 (2.8%) | 5 | 1/143 (0.7%) | 14 | 8/214 (3.7%) | 11 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL DISCOMFORT | 2/145 (1.4%) | 2 | 2/143 (1.4%) | 4 | 9/214 (4.2%) | 10 |
| ABDOMINAL PAIN | 5/145 (3.4%) | 5 | 5/143 (3.5%) | 5 | 7/214 (3.3%) | 11 |
| ABDOMINAL PAIN UPPER | 4/145 (2.8%) | 4 | 3/143 (2.1%) | 3 | 7/214 (3.3%) | 8 |
| CONSTIPATION | 2/145 (1.4%) | 2 | 5/143 (3.5%) | 5 | 18/214 (8.4%) | 19 |
| DIARRHOEA | 12/145 (8.3%) | 14 | 10/143 (7%) | 12 | 35/214 (16.4%) | 62 |
| DYSPEPSIA | 3/145 (2.1%) | 3 | 5/143 (3.5%) | 5 | 6/214 (2.8%) | 6 |
| NAUSEA | 15/145 (10.3%) | 19 | 11/143 (7.7%) | 21 | 46/214 (21.5%) | 74 |
| TOOTHACHE | 0/145 (0%) | 0 | 3/143 (2.1%) | 3 | 7/214 (3.3%) | 10 |
| VOMITING | 12/145 (8.3%) | 16 | 11/143 (7.7%) | 15 | 33/214 (15.4%) | 46 |
| General disorders | ||||||
| ASTHENIA | 2/145 (1.4%) | 2 | 4/143 (2.8%) | 5 | 17/214 (7.9%) | 20 |
| CHILLS | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 8/214 (3.7%) | 13 |
| FACE OEDEMA | 3/145 (2.1%) | 3 | 2/143 (1.4%) | 3 | 12/214 (5.6%) | 15 |
| FATIGUE | 4/145 (2.8%) | 4 | 4/143 (2.8%) | 4 | 14/214 (6.5%) | 15 |
| NON-CARDIAC CHEST PAIN | 4/145 (2.8%) | 4 | 2/143 (1.4%) | 2 | 9/214 (4.2%) | 10 |
| OEDEMA PERIPHERAL | 3/145 (2.1%) | 4 | 12/143 (8.4%) | 14 | 31/214 (14.5%) | 49 |
| PAIN | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 20/214 (9.3%) | 26 |
| PYREXIA | 5/145 (3.4%) | 5 | 5/143 (3.5%) | 5 | 21/214 (9.8%) | 23 |
| THROMBOSIS IN DEVICE | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 8/214 (3.7%) | 14 |
| Infections and infestations | ||||||
| BRONCHITIS | 2/145 (1.4%) | 2 | 5/143 (3.5%) | 5 | 4/214 (1.9%) | 4 |
| CELLULITIS | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 7/214 (3.3%) | 7 |
| NASOPHARYNGITIS | 9/145 (6.2%) | 11 | 5/143 (3.5%) | 6 | 11/214 (5.1%) | 12 |
| UPPER RESPIRATORY TRACT INFECTION | 8/145 (5.5%) | 8 | 8/143 (5.6%) | 11 | 12/214 (5.6%) | 16 |
| URINARY TRACT INFECTION | 1/145 (0.7%) | 1 | 5/143 (3.5%) | 7 | 6/214 (2.8%) | 6 |
| Injury, poisoning and procedural complications | ||||||
| ARTERIOVENOUS FISTULA SITE COMPLICATION | 14/145 (9.7%) | 21 | 15/143 (10.5%) | 19 | 52/214 (24.3%) | 85 |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | 2/145 (1.4%) | 6 | 6/143 (4.2%) | 7 | 12/214 (5.6%) | 18 |
| CONTUSION | 6/145 (4.1%) | 6 | 6/143 (4.2%) | 6 | 9/214 (4.2%) | 12 |
| FALL | 0/145 (0%) | 0 | 4/143 (2.8%) | 4 | 7/214 (3.3%) | 9 |
| HAEMODIALYSIS-INDUCED SYMPTOM | 9/145 (6.2%) | 19 | 10/143 (7%) | 14 | 58/214 (27.1%) | 183 |
| PROCEDURAL DIZZINESS | 2/145 (1.4%) | 3 | 4/143 (2.8%) | 7 | 8/214 (3.7%) | 20 |
| PROCEDURAL HEADACHE | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 8/214 (3.7%) | 14 |
| PROCEDURAL HYPERTENSION | 0/145 (0%) | 0 | 1/143 (0.7%) | 1 | 12/214 (5.6%) | 26 |
| PROCEDURAL HYPOTENSION | 16/145 (11%) | 67 | 19/143 (13.3%) | 143 | 75/214 (35%) | 567 |
| PROCEDURAL NAUSEA | 2/145 (1.4%) | 4 | 1/143 (0.7%) | 1 | 13/214 (6.1%) | 18 |
| PROCEDURAL PAIN | 1/145 (0.7%) | 2 | 3/143 (2.1%) | 3 | 17/214 (7.9%) | 20 |
| VASCULAR GRAFT COMPLICATION | 4/145 (2.8%) | 8 | 2/143 (1.4%) | 3 | 11/214 (5.1%) | 13 |
| VASCULAR GRAFT THROMBOSIS | 1/145 (0.7%) | 1 | 0/143 (0%) | 0 | 7/214 (3.3%) | 8 |
| Metabolism and nutrition disorders | ||||||
| FLUID OVERLOAD | 7/145 (4.8%) | 8 | 5/143 (3.5%) | 7 | 19/214 (8.9%) | 45 |
| HYPERKALAEMIA | 3/145 (2.1%) | 3 | 5/143 (3.5%) | 5 | 21/214 (9.8%) | 21 |
| HYPOGLYCAEMIA | 4/145 (2.8%) | 5 | 5/143 (3.5%) | 5 | 7/214 (3.3%) | 10 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 5/145 (3.4%) | 5 | 2/143 (1.4%) | 2 | 14/214 (6.5%) | 16 |
| BACK PAIN | 6/145 (4.1%) | 7 | 6/143 (4.2%) | 6 | 17/214 (7.9%) | 20 |
| MUSCLE SPASMS | 5/145 (3.4%) | 8 | 8/143 (5.6%) | 9 | 4/214 (1.9%) | 6 |
| MUSCULOSKELETAL PAIN | 2/145 (1.4%) | 2 | 1/143 (0.7%) | 1 | 8/214 (3.7%) | 9 |
| PAIN IN EXTREMITY | 9/145 (6.2%) | 12 | 7/143 (4.9%) | 7 | 24/214 (11.2%) | 28 |
| Nervous system disorders | ||||||
| DIZZINESS | 8/145 (5.5%) | 11 | 9/143 (6.3%) | 19 | 34/214 (15.9%) | 45 |
| HEADACHE | 8/145 (5.5%) | 9 | 13/143 (9.1%) | 23 | 40/214 (18.7%) | 61 |
| Psychiatric disorders | ||||||
| ANXIETY | 3/145 (2.1%) | 3 | 1/143 (0.7%) | 1 | 7/214 (3.3%) | 8 |
| INSOMNIA | 5/145 (3.4%) | 5 | 2/143 (1.4%) | 2 | 7/214 (3.3%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 14/145 (9.7%) | 15 | 10/143 (7%) | 13 | 18/214 (8.4%) | 23 |
| DYSPNOEA | 6/145 (4.1%) | 6 | 11/143 (7.7%) | 11 | 28/214 (13.1%) | 36 |
| DYSPNOEA EXERTIONAL | 1/145 (0.7%) | 2 | 2/143 (1.4%) | 2 | 8/214 (3.7%) | 10 |
| NASAL CONGESTION | 1/145 (0.7%) | 1 | 1/143 (0.7%) | 1 | 7/214 (3.3%) | 7 |
| OROPHARYNGEAL PAIN | 0/145 (0%) | 0 | 2/143 (1.4%) | 2 | 7/214 (3.3%) | 11 |
| Skin and subcutaneous tissue disorders | ||||||
| PRURITUS | 1/145 (0.7%) | 1 | 2/143 (1.4%) | 2 | 10/214 (4.7%) | 10 |
| Vascular disorders | ||||||
| HYPERTENSION | 5/145 (3.4%) | 5 | 5/143 (3.5%) | 6 | 8/214 (3.7%) | 8 |
| HYPOTENSION | 4/145 (2.8%) | 5 | 5/143 (3.5%) | 5 | 10/214 (4.7%) | 11 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Senior Director, Clinical Research & Development |
|---|---|
| Organization | Rockwell Medical |
| Phone | 248-960-9009 |
| rd@rockwellmed.com |
Responsible Party:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01322347
Other Study ID Numbers:
- RMTI-SFP-5
First Posted:
Mar 24, 2011
Last Update Posted:
Apr 26, 2017
Last Verified:
Apr 1, 2017