CRUISE 1: Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Sponsor
Rockwell Medical Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT01320202
Collaborator
(none)
305
47
2
32.1
6.5
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): 1-4 weeks 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Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely.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
:
305 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 1) Study
Study Start Date
:
Mar 1, 2011
Actual Primary Completion Date
:
May 1, 2013
Actual Study Completion Date
:
Nov 1, 2013
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 the 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 with standard error.
- Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb [Hgb measured weekly; up to 48 weeks from the 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 the 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 TSAT (Transferrin) From Pre-dialysis to Post-dialysis. [Up to 48 weeks from the 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- to Post-dialysis. [Up to 48 weeks from the 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 Receiving Transfusion [up to 48 weeks from the 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 the 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 (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel [Up to 48 weeks from the 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), Serum Iron, and Total Iron-Binding Capacity (TIBC) [Up to 48 weeks from the 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 Content (CHr) [Up to 48 weeks from the date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified.
- Change From Baseline to End-of-Treatment (EoT) in Ferritin [Up to 48 weeks from the date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin will be quantified.
- Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin [Up to 48 weeks from the date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin will be quantified.
- Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) [Up to 48 weeks from the date of randomization]
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) will be quantified.
- Variability of Hemoglobin Concentration: Temporal Trend [Hgb measured weekly; up to 48 weeks from the 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 [Hgb measured weekly; up to 48 weeks from the date of randomization]
The mean residual standard deviation of hemoglobin concentration value 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 | Bakersfield | California | United States | 93308 | |
| 2 | Investigative Site | Chula Vista | California | United States | 91910 |
| 3 | Cudahy | California | United States | 90201 | |
| 4 | Downey | California | United States | 90240 | |
| 5 | Encino | California | United States | 91316 | |
| 6 | Los Angeles | California | United States | 90022 | |
| 7 | Los Angeles | California | United States | 90033 | |
| 8 | Los Angeles | California | United States | 90057 | |
| 9 | Los Angeles | California | United States | 90404 | |
| 10 | National City | California | United States | 91950 | |
| 11 | Northridge | California | United States | 91324 | |
| 12 | Ontario | California | United States | 91764 | |
| 13 | Panorama City | California | United States | 91402 | |
| 14 | Riverside | California | United States | 92505 | |
| 15 | San Dimas | California | United States | 91773 | |
| 16 | Simi Valley | California | United States | 93065 | |
| 17 | West Covina | California | United States | 91792 | |
| 18 | Yuba City | California | United States | 95991 | |
| 19 | Investigative Site | Waterbury | Connecticut | United States | 06708 |
| 20 | Waterbury | Connecticut | United States | 06708 | |
| 21 | Coral Springs | Florida | United States | 33071 | |
| 22 | Miami | Florida | United States | 33150 | |
| 23 | Investigative Site | Augusta | Georgia | United States | 30901 |
| 24 | Chicago | Illinois | United States | 60617 | |
| 25 | Michigan City | Indiana | United States | 46360 | |
| 26 | Detroit | Michigan | United States | 48202 | |
| 27 | Las Vegas | Nevada | United States | 89102 | |
| 28 | Investigative Site | Mineola | New York | United States | 11501 |
| 29 | Investigative Site | Ridgewood | New York | United States | 11385 |
| 30 | Rosedale | New York | United States | 11422 | |
| 31 | Yonkers | New York | United States | 10704 | |
| 32 | Asheville | North Carolina | United States | 28801 | |
| 33 | Durham | North Carolina | United States | 27704 | |
| 34 | Winston-Salem | North Carolina | United States | 27105 | |
| 35 | Cincinnati | Ohio | United States | 45206 | |
| 36 | Toledo | Ohio | United States | 43613 | |
| 37 | Sumter | South Carolina | United States | 29150 | |
| 38 | Chattanooga | Tennessee | United States | 37404 | |
| 39 | Arlington | Texas | United States | 76011 | |
| 40 | Fort Worth | Texas | United States | 76164 | |
| 41 | Investigative Site | Houston | Texas | United States | 77004 |
| 42 | Houston | Texas | United States | 77081 | |
| 43 | San Antonio | Texas | United States | 78207 | |
| 44 | Fairfax | Virginia | United States | 22030 | |
| 45 | Shorewood | Wisconsin | United States | 53211 | |
| 46 | Caguas | Puerto Rico | 00725 | ||
| 47 | Carolina | Puerto Rico | 00987 |
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:
NCT01320202
Other Study ID Numbers:
- RMTI-SFP-4
First Posted:
Mar 22, 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 |
|---|---|---|
| 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 | 152 | 153 |
| Comp 48 Wks in St 2 | 27 | 27 |
| Comp St 2 Due to ESA/IV Iron Needs | 69 | 82 |
| Enrolled in St 3 | 98 | 109 |
| Completed St 3 | 79 | 82 |
| COMPLETED | 96 | 109 |
| NOT COMPLETED | 56 | 44 |
Baseline Characteristics
| Arm/Group Title | Soluble Ferric Pyrophosphate (SFP) in Dialysate | Standard Dialysate | 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 18 months. | 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 18 months. | Total of all reporting groups |
| Overall Participants | 152 | 153 | 305 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
56.6
(12.56)
|
59.9
(13.01)
|
58.3
(12.87)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
50
32.9%
|
48
31.4%
|
98
32.1%
|
| Male |
102
67.1%
|
105
68.6%
|
207
67.9%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||
| Hispanic or Latino |
74
48.7%
|
65
42.5%
|
139
45.6%
|
| Not Hispanic or Latino |
78
51.3%
|
88
57.5%
|
166
54.4%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||
| American Indian or Alaska Native |
6
3.9%
|
12
7.8%
|
18
5.9%
|
| Asian |
8
5.3%
|
5
3.3%
|
13
4.3%
|
| Native Hawaiian or Other Pacific Islander |
2
1.3%
|
0
0%
|
2
0.7%
|
| Black or African American |
50
32.9%
|
48
31.4%
|
98
32.1%
|
| White |
84
55.3%
|
84
54.9%
|
168
55.1%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
2
1.3%
|
4
2.6%
|
6
2%
|
| Region of Enrollment (participants) [Number] | |||
| United States |
145
95.4%
|
143
93.5%
|
288
94.4%
|
| Puerto Rico |
7
4.6%
|
10
6.5%
|
17
5.6%
|
| post-dialysis body weight (kilograms) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [kilograms] |
84.08
(23.264)
|
83.15
(22.166)
|
83.61
(22.685)
|
| height (centimeters) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [centimeters] |
168.48
(10.197)
|
169.17
(9.350)
|
168.82
(9.771)
|
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 with standard error. |
| Time Frame | Hgb measured weekly; up to 48 weeks from the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat populations: all randomized subjects who received at least one dose of study medication and had at least one post-dose hemoglobin measurement obtained. |
| 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 | 148 | 151 |
| Least Squares Mean (Standard Error) [grams per liter] |
0.6
(1.15)
|
-3.0
(1.14)
|
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) % to |
|
| Parameter Dispersion |
Type: Standard Error of the Mean Value: 1.40 |
|
| 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 the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat population: 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 | 148 | 151 |
| mean pre-dialysis serum iron |
12.1
(4.15)
|
10.8
(3.04)
|
| mean post-dialysis serum iron |
29.6
(8.64)
|
11.5
(3.91)
|
| serum iron change from pre- to post-dialysis |
17.5
(8.70)
|
0.6
(3.08)
|
| Title | Mean Change in TSAT (Transferrin) 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 the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to treat: all randomized subjects who had 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 | 148 | 151 |
| mean pre-dialysis TSAT(transferrin) |
24.9
(6.86)
|
22.4
(5.97)
|
| mean post-dialysis TSAT(transferrin) |
57.9
(15.94)
|
22.2
(7.80)
|
| pre- to post-dialysis change in TSAT |
32.7
(15.83)
|
-0.4
(6.86)
|
| Title | Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- 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 the 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 | 148 | 151 |
| mean pre-dialysis UIBC |
31.49
(6.797)
|
32.27
(6.580)
|
| mean post-dialysis UIBC |
19.48
(7.911)
|
34.51
(7.208)
|
| pre- to post-dialysis change in UIBC |
-11.86
(6.604)
|
2.38
(3.253)
|
| Title | Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving 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 the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT): all patients randomized are included. |
| 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 152 | 153 |
| Number [participants] |
3
2%
|
11
7.2%
|
| 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 the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-Treat (ITT): all patients randomized are included. |
| 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 152 | 153 |
| Number [units of red blood cells or whole blood] |
5
|
19
|
| Title | Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and 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 the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| CHr: % of change from baseline |
-0.64
(3.800)
|
-2.73
(4.289)
|
| Ferritin: % of change from baseline |
-14.8
(27.68)
|
-28.5
(34.35)
|
| Pre-dialysis UIBC: % of change from baseline |
8.36
(53.186)
|
7.62
(14.818)
|
| Pre-dialysis serum iron: % of change from baseline |
4.644
(53.1728)
|
-4.628
(29.0307)
|
| Pre-dialysis transferrin: % change from baseline |
1.718
(8.5133)
|
2.633
(9.7691)
|
| Pre-dialysis TIBC: % of change from baseline |
1.80
(9.255)
|
2.88
(10.253)
|
| Pre-dialysis TSAT: % of change from baseline |
1.8
(44.99)
|
-7.8
(26.42)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and 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 the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| Baseline UIBC |
30.91
(6.784)
|
30.77
(6.452)
|
| EoT UIBC |
32.76
(13.734)
|
33.03
(7.527)
|
| UIBC: Change from Baseline to EoT |
1.93
(13.265)
|
2.14
(4.447)
|
| Baseline Serum Iron |
11.976
(3.9192)
|
11.443
(3.9198)
|
| EoT Serum Iron |
11.911
(4.5412)
|
10.389
(3.4941)
|
| Serum Iron: Change from Baseline to EoT |
-0.196
(4.7462)
|
-1.051
(3.6562)
|
| Baseline TIBC |
42.88
(7.458)
|
42.22
(7.380)
|
| EoT TIBC |
43.59
(8.140)
|
43.40
(7.964)
|
| TIBC: Change from Baseline to EoT |
0.65
(4.051)
|
1.08
(4.296)
|
| Title | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) |
|---|---|
| Description | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) will be quantified. |
| Time Frame | Up to 48 weeks from the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| Baseline CHr |
32.37
(1.985)
|
32.57
(1.953)
|
| EoT CHr |
32.12
(2.016)
|
31.64
(2.019)
|
| CHr: Change from Baseline to EoT |
-0.23
(1.203)
|
-0.91
(1.413)
|
| 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 will be quantified. |
| Time Frame | Up to 48 weeks from the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| Baseline Ferritin |
509.6
(194.16)
|
511.3
(209.68)
|
| EoT Ferritin |
440.7
(216.41)
|
366.9
(224.01)
|
| Ferritin: Change from Baseline to EoT |
-72.3
(133.40)
|
-143.1
(188.28)
|
| 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 will be quantified. |
| Time Frame | Up to 48 weeks from the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| Baseline Pre-Dialysis Transferrin |
1.928
(0.3427)
|
1.908
(0.3475)
|
| EoT Pre-Dialysis Transferrin |
1.958
(0.3767)
|
1.957
(0.3731)
|
| Pre-Dialysis Ferritin: Change from Baseline to EoT |
0.029
(0.1695)
|
0.044
(0.1883)
|
| 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) will be quantified. |
| Time Frame | Up to 48 weeks from the 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| Baseline Pre-Dialysis TSAT |
28.1
(8.13)
|
27.1
(7.79)
|
| EoT Pre-Dialysis TSAT |
27.3
(8.52)
|
24.0
(7.44)
|
| Pre-Dialysis TSAT: Change from Baseline to EoT |
-1.1
(9.16)
|
-3.0
(7.70)
|
| 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 | Hgb measured weekly; up to 48 weeks from the 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 | 148 | 151 |
| Mean (Standard Deviation) [grams per liter per week] |
0.060
(0.298)
|
0.002
(0.235)
|
| Title | Variability of Hemoglobin Concentration: Residual Standard Deviation |
|---|---|
| Description | The mean residual standard deviation of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2. |
| Time Frame | Hgb measured weekly; up to 48 weeks from the 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 | 148 | 151 |
| Mean (Standard Deviation) [grams per liter] |
4.104
(2.220)
|
4.588
(1.949)
|
| Title | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb |
|---|---|
| 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 the date of randomization |
Outcome Measure Data
| Analysis Population Description |
|---|
| modified intent-to-treat: all randomized patients 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 in Stage 2. | 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 in Stage 2. |
| Measure Participants | 148 | 151 |
| mean baseline hemoglobin |
109.6
(5.91)
|
109.0
(6.36)
|
| mean end-of-treatment hemoglobin |
109.1
(12.53)
|
105.2
(13.65)
|
| mean change in Hemoglobin at end-of-treatment |
-0.4
(11.67)
|
-3.9
(12.52)
|
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 = 300, which is 5 patients fewer than the number of patients randomized. This discrepancy is due to the fact that the Safety population includes only those subjects exposed to study drug. Five subjects withdrew from Stage 2 and 2 subjects withdrew from Stage 3 prior to exposure. | |||||
| Arm/Group Title | Stage 2 Placebo (Standard Dialysate) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate | |||
| 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 Placebo (Standard Dialysate) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Stage 2 Placebo (Standard Dialysate) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 45/151 (29.8%) | 36/149 (24.2%) | 81/205 (39.5%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 1/205 (0.5%) | 1 |
| ANAEMIA OF CHRONIC DISEASE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| THROMBOCYTOPENIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Cardiac disorders | ||||||
| ACUTE MYOCARDIAL INFARCTION | 3/151 (2%) | 3 | 3/149 (2%) | 3 | 1/205 (0.5%) | 1 |
| ANGINA PECTORIS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 3/205 (1.5%) | 3 |
| ANGINA UNSTABLE | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| ATRIAL FIBRILLATION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 3/205 (1.5%) | 3 |
| ATRIAL FLUTTER | 1/151 (0.7%) | 2 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| ATRIOVENTRICULAR BLOCK SECOND DEGREE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CARDIAC ARREST | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 5/205 (2.4%) | 5 |
| CARDIAC FAILURE CONGESTIVE | 5/151 (3.3%) | 8 | 1/149 (0.7%) | 2 | 4/205 (2%) | 8 |
| CARDIOGENIC SHOCK | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CARDIOMYOPATHY | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| CARDIO-RESPIRATORY ARREST | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| CONGESTIVE CARDIOMYOPATHY | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CORONARY ARTERY DISEASE | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 3/205 (1.5%) | 3 |
| INTRACARDIAC THROMBUS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| MYOCARDIAL INFARCTION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| SUPRAVENTRICULAR TACHYCARDIA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| Endocrine disorders | ||||||
| HYPERPARATHYROIDISM SECONDARY | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL PAIN | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| CROHN'S DISEASE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| DIARRHOEA | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| DIVERTICULUM INTESTINAL HAEMORRHAGIC | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| DYSPHAGIA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| GASTRITIS | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| GASTRITIS EROSIVE | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/205 (0.5%) | 1 |
| GASTROINTESTINAL HAEMORRHAGE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| GASTROOESOPHAGEAL REFLUX DISEASE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 3/205 (1.5%) | 3 |
| LOWER GASTROINTESTINAL HAEMORRHAGE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| NAUSEA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| OESOPHAGEAL ULCER HAEMORRHAGE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| PANCREATITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PANCREATITIS ACUTE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PORTAL HYPERTENSIVE GASTROPATHY | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| SMALL INTESTINAL OBSTRUCTION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| VOMITING | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| General disorders | ||||||
| ADVERSE DRUG REACTION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CATHETER SITE HAEMATOMA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CHEST PAIN | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CHILLS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| DEATH | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| DEVICE DISLOCATION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| NON-CARDIAC CHEST PAIN | 5/151 (3.3%) | 5 | 1/149 (0.7%) | 1 | 3/205 (1.5%) | 3 |
| PYREXIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| STENT-GRAFT ENDOLEAK | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| SUDDEN DEATH | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| Hepatobiliary disorders | ||||||
| CHOLANGITIS | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| Infections and infestations | ||||||
| ARTERIOVENOUS GRAFT SITE INFECTION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| BACTERAEMIA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| CELLULITIS | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 2/205 (1%) | 2 |
| CLOSTRIDIUM DIFFICILE COLITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| DEVICE RELATED INFECTION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| DIVERTICULITIS | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| ENDOCARDITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| GANGRENE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| GASTROENTERITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 3/205 (1.5%) | 3 |
| GASTROENTERITIS VIRAL | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| INFECTED SKIN ULCER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| LOBAR PNEUMONIA | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| OSTEOMYELITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| PNEUMONIA | 5/151 (3.3%) | 5 | 4/149 (2.7%) | 4 | 5/205 (2.4%) | 10 |
| RENAL CYST INFECTION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| SEPSIS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 4/205 (2%) | 4 |
| STAPHYLOCOCCAL BACTERAEMIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 3/205 (1.5%) | 3 |
| UPPER RESPIRATORY TRACT INFECTION | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| URINARY TRACT INFECTION | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 2/205 (1%) | 2 |
| UROSEPSIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| VIRAL INFECTION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Injury, poisoning and procedural complications | ||||||
| ANAEMIA POSTOPERATIVE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA ANEURYSM | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| ARTERIOVENOUS FISTULA OCCLUSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA SITE COMPLICATION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA SITE HAEMATOMA | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/205 (0.5%) | 1 |
| ARTERIOVENOUS FISTULA THROMBOSIS | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 4/205 (2%) | 4 |
| COMMINUTED FRACTURE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| FACIAL BONES FRACTURE | 1/151 (0.7%) | 1 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| HEAD INJURY | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| HIP FRACTURE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| MUSCLE RUPTURE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| MUSCLE STRAIN | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| POST PROCEDURAL HAEMATOMA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PROCEDURAL HYPERTENSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PROCEDURAL HYPOTENSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| ROAD TRAFFIC ACCIDENT | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| VASCULAR GRAFT THROMBOSIS | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 4/205 (2%) | 6 |
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| DEHYDRATION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| DIABETES MELLITUS INADEQUATE CONTROL | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| DIABETIC FOOT | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| FLUID OVERLOAD | 10/151 (6.6%) | 12 | 2/149 (1.3%) | 2 | 5/205 (2.4%) | 5 |
| HYPERGLYCAEMIA | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| HYPERKALAEMIA | 4/151 (2.6%) | 7 | 0/149 (0%) | 0 | 9/205 (4.4%) | 11 |
| HYPOGLYCAEMIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| HYPOVOLAEMIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 2/205 (1%) | 2 |
| Musculoskeletal and connective tissue disorders | ||||||
| BACK PAIN | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| CERVICAL SPINAL STENOSIS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| CHONDROCALCINOSIS PYROPHOSPHATE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| MUSCULOSKELETAL CHEST PAIN | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| OSTEOARTHRITIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| POLYMYALGIA RHEUMATICA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| SPONDYLOLISTHESIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| CERVIX CARCINOMA STAGE 0 | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| COLORECTAL CANCER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| HAEMANGIOMA OF LIVER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| OVARIAN LOW MALIGNANT POTENTIAL TUMOUR | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PROSTATE CANCER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| RENAL CELL CARCINOMA | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| Nervous system disorders | ||||||
| CEREBROVASCULAR ACCIDENT | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| CONVULSION | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| DIZZINESS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ENCEPHALOPATHY | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| HEADACHE | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| HEPATIC ENCEPHALOPATHY | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 1/205 (0.5%) | 1 |
| HYPERTENSIVE ENCEPHALOPATHY | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| LOSS OF CONSCIOUSNESS | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| METABOLIC ENCEPHALOPATHY | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 3/205 (1.5%) | 3 |
| SYNCOPE | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 3/205 (1.5%) | 3 |
| TOXICITY TO VARIOUS AGENTS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| Psychiatric disorders | ||||||
| ANXIETY | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| MENTAL STATUS CHANGES | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Renal and urinary disorders | ||||||
| RENAL CYST HAEMORRHAGE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| Reproductive system and breast disorders | ||||||
| ENDOMETRIAL HYPERPLASIA | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| ACUTE PULMONARY OEDEMA | 1/151 (0.7%) | 4 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| ACUTE RESPIRATORY FAILURE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| PLEURAL EFFUSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 2 |
| PNEUMONIA ASPIRATION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| PULMONARY CONGESTION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| PULMONARY OEDEMA | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| RESPIRATORY ARREST | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| RESPIRATORY DISTRESS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| RESPIRATORY FAILURE | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| Skin and subcutaneous tissue disorders | ||||||
| SKIN ULCER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Surgical and medical procedures | ||||||
| CARDIOVERSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| Vascular disorders | ||||||
| ACCELERATED HYPERTENSION | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| ARTERIOSCLEROSIS | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 3 |
| DEEP VEIN THROMBOSIS | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| HYPERTENSION | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 5/205 (2.4%) | 5 |
| HYPERTENSIVE CRISIS | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 4/205 (2%) | 4 |
| HYPERTENSIVE EMERGENCY | 1/151 (0.7%) | 1 | 0/149 (0%) | 0 | 0/205 (0%) | 0 |
| HYPOTENSION | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| ORTHOSTATIC HYPOTENSION | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 0/205 (0%) | 0 |
| PERIPHERAL ARTERIAL OCCLUSIVE DISEASE | 0/151 (0%) | 0 | 1/149 (0.7%) | 2 | 0/205 (0%) | 0 |
| PERIPHERAL VASCULAR DISORDER | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
| SHOCK | 0/151 (0%) | 0 | 0/149 (0%) | 0 | 1/205 (0.5%) | 1 |
Other (Not Including Serious) Adverse Events |
||||||
| Stage 2 Placebo (Standard Dialysate) | Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Stage 3 Soluble Ferric Pyrophosphate (SFP) in Dialysate | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 100/151 (66.2%) | 96/149 (64.4%) | 148/205 (72.2%) | |||
| Blood and lymphatic system disorders | ||||||
| ANAEMIA | 7/151 (4.6%) | 10 | 3/149 (2%) | 4 | 11/205 (5.4%) | 11 |
| Cardiac disorders | ||||||
| ANGINA PECTORIS | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 7/205 (3.4%) | 7 |
| Gastrointestinal disorders | ||||||
| ABDOMINAL PAIN UPPER | 6/151 (4%) | 6 | 3/149 (2%) | 3 | 7/205 (3.4%) | 7 |
| CONSTIPATION | 2/151 (1.3%) | 2 | 1/149 (0.7%) | 1 | 11/205 (5.4%) | 12 |
| DIARRHOEA | 15/151 (9.9%) | 17 | 13/149 (8.7%) | 14 | 30/205 (14.6%) | 45 |
| NAUSEA | 14/151 (9.3%) | 25 | 11/149 (7.4%) | 13 | 20/205 (9.8%) | 31 |
| VOMITING | 12/151 (7.9%) | 16 | 5/149 (3.4%) | 6 | 16/205 (7.8%) | 18 |
| General disorders | ||||||
| ASTHENIA | 7/151 (4.6%) | 7 | 7/149 (4.7%) | 7 | 9/205 (4.4%) | 9 |
| FATIGUE | 2/151 (1.3%) | 2 | 7/149 (4.7%) | 7 | 2/205 (1%) | 2 |
| MALAISE | 1/151 (0.7%) | 1 | 2/149 (1.3%) | 2 | 9/205 (4.4%) | 10 |
| NON-CARDIAC CHEST PAIN | 0/151 (0%) | 0 | 1/149 (0.7%) | 1 | 9/205 (4.4%) | 9 |
| OEDEMA PERIPHERAL | 6/151 (4%) | 7 | 8/149 (5.4%) | 12 | 14/205 (6.8%) | 27 |
| PAIN | 4/151 (2.6%) | 4 | 2/149 (1.3%) | 2 | 10/205 (4.9%) | 11 |
| PYREXIA | 4/151 (2.6%) | 4 | 7/149 (4.7%) | 12 | 10/205 (4.9%) | 11 |
| THROMBOSIS IN DEVICE | 5/151 (3.3%) | 6 | 3/149 (2%) | 3 | 6/205 (2.9%) | 15 |
| Infections and infestations | ||||||
| NASOPHARYNGITIS | 6/151 (4%) | 9 | 2/149 (1.3%) | 2 | 9/205 (4.4%) | 9 |
| UPPER RESPIRATORY TRACT INFECTION | 5/151 (3.3%) | 6 | 4/149 (2.7%) | 4 | 5/205 (2.4%) | 6 |
| URINARY TRACT INFECTION | 2/151 (1.3%) | 2 | 7/149 (4.7%) | 8 | 3/205 (1.5%) | 5 |
| Injury, poisoning and procedural complications | ||||||
| ARTERIOVENOUS FISTULA SITE COMPLICATION | 19/151 (12.6%) | 23 | 17/149 (11.4%) | 30 | 25/205 (12.2%) | 58 |
| ARTERIOVENOUS FISTULA SITE HAEMORRHAGE | 3/151 (2%) | 3 | 4/149 (2.7%) | 8 | 7/205 (3.4%) | 14 |
| ARTERIOVENOUS FISTULA THROMBOSIS | 3/151 (2%) | 3 | 2/149 (1.3%) | 2 | 7/205 (3.4%) | 10 |
| HAEMODIALYSIS-INDUCED SYMPTOM | 5/151 (3.3%) | 9 | 7/149 (4.7%) | 11 | 39/205 (19%) | 199 |
| PROCEDURAL DIZZINESS | 1/151 (0.7%) | 2 | 1/149 (0.7%) | 4 | 7/205 (3.4%) | 9 |
| PROCEDURAL HYPOTENSION | 41/151 (27.2%) | 216 | 43/149 (28.9%) | 174 | 68/205 (33.2%) | 494 |
| VASCULAR GRAFT COMPLICATION | 1/151 (0.7%) | 1 | 4/149 (2.7%) | 8 | 13/205 (6.3%) | 25 |
| Metabolism and nutrition disorders | ||||||
| DECREASED APPETITE | 4/151 (2.6%) | 5 | 0/149 (0%) | 0 | 8/205 (3.9%) | 8 |
| FLUID OVERLOAD | 2/151 (1.3%) | 5 | 5/149 (3.4%) | 7 | 8/205 (3.9%) | 15 |
| HYPERKALAEMIA | 4/151 (2.6%) | 4 | 4/149 (2.7%) | 6 | 7/205 (3.4%) | 7 |
| VITAMIN D DEFICIENCY | 2/151 (1.3%) | 2 | 0/149 (0%) | 0 | 9/205 (4.4%) | 34 |
| Musculoskeletal and connective tissue disorders | ||||||
| ARTHRALGIA | 3/151 (2%) | 3 | 6/149 (4%) | 9 | 15/205 (7.3%) | 17 |
| BACK PAIN | 4/151 (2.6%) | 4 | 5/149 (3.4%) | 6 | 13/205 (6.3%) | 16 |
| MUSCLE SPASMS | 11/151 (7.3%) | 20 | 7/149 (4.7%) | 15 | 10/205 (4.9%) | 33 |
| MUSCULOSKELETAL PAIN | 2/151 (1.3%) | 2 | 2/149 (1.3%) | 4 | 13/205 (6.3%) | 16 |
| PAIN IN EXTREMITY | 7/151 (4.6%) | 7 | 13/149 (8.7%) | 18 | 13/205 (6.3%) | 13 |
| Nervous system disorders | ||||||
| DIZZINESS | 14/151 (9.3%) | 16 | 13/149 (8.7%) | 17 | 26/205 (12.7%) | 52 |
| HEADACHE | 8/151 (5.3%) | 9 | 14/149 (9.4%) | 16 | 38/205 (18.5%) | 53 |
| HYPOAESTHESIA | 0/151 (0%) | 0 | 5/149 (3.4%) | 7 | 5/205 (2.4%) | 5 |
| Psychiatric disorders | ||||||
| INSOMNIA | 3/151 (2%) | 3 | 0/149 (0%) | 0 | 7/205 (3.4%) | 7 |
| Respiratory, thoracic and mediastinal disorders | ||||||
| COUGH | 10/151 (6.6%) | 11 | 11/149 (7.4%) | 14 | 21/205 (10.2%) | 27 |
| DYSPNOEA | 7/151 (4.6%) | 9 | 6/149 (4%) | 8 | 22/205 (10.7%) | 34 |
| Vascular disorders | ||||||
| HYPERTENSION | 2/151 (1.3%) | 2 | 3/149 (2%) | 3 | 8/205 (3.9%) | 9 |
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 & Operations |
|---|---|
| Organization | Rockwell Medical |
| Phone | 248-960-9009 |
| rd@rockwellmed.com |
Responsible Party:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT01320202
Other Study ID Numbers:
- RMTI-SFP-4
First Posted:
Mar 22, 2011
Last Update Posted:
Apr 26, 2017
Last Verified:
Apr 1, 2017