Dose Ranging Study of Dialysate Containing Soluble Iron to Treat Subjects With End Stage Renal Disease (ESRD) Receiving Chronic Hemodialysis
Sponsor
Rockwell Medical Technologies, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00548249
Collaborator
(none)
131
28
5
29
4.7
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether Dialysate containing soluble iron (Soluble Ferric Pyrophosphate) is safe and effective in maintaining physiological iron levels during chronic hemodialysis.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Detailed Description
The study was designed to evaluate the efficacy of SFP-containing dialysate solution in maintaining physiological iron levels during chronic hemodialysis, as measured by the primary endpoint of the percent of patients whose Hemoglobin (Hgb) decreased by at least 1.0 gram/ deciliter (g/dL) from baseline. The efficacy and safety findings are to be used to determine the optimal concentration of SFP needed to safely maintain iron levels, compensating for iron losses during chronic hemodialysis.
Study Design
Study Type:
Interventional
Actual Enrollment
:
131 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Dose Ranging Study of Dialysate Containing Soluble Ferric Pyrophosphate (SFP) Versus Control in Subjects With ESRD Receiving Chronic Hemodialysis.
Study Start Date
:
Aug 1, 2007
Actual Primary Completion Date
:
Oct 1, 2009
Actual Study Completion Date
:
Jan 1, 2010
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: 0 µg iron/dL of dialysate Placebo 0 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Device: Standard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
|
| Experimental: 5 µg iron/dL of dialysate 5 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Drug: Soluble Ferric Pyrophosphate
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
|
| Experimental: 10 µg iron/dL of dialysate 10 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Drug: Soluble Ferric Pyrophosphate
Patients received 10 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
|
| Experimental: 12 µg iron/dL of dialysate 12 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Drug: Soluble Ferric Pyrophosphate
Patients received 12 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
|
| Experimental: 15 µg iron/dL of dialysate 15 micrograms (µg) of iron/ deciliter (dL) of dialysate |
Drug: Soluble Ferric Pyrophosphate
Patients received 15 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. [up to 26 weeks]
Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization).
Secondary Outcome Measures
- Change From Baseline in Hemoglobin (Hgb) [two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)]
- Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group. [Up to 26 weeks]
Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL
- Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. [Every 4 weeks]
Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks).
- Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. [At each dialysis session for up to 26 weeks]
- Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. [two separate sessions measured one week apart.]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Selected Inclusion Criteria:
-
Adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (ESRD) three times a week
-
Hemoglobin (Hgb) values on two successive screening/baseline measures immediately prior to the start of the study averaging 10.1 to 11.5 grams/ deciliter (g/dL), inclusive
-
Transferrin Saturation (TSAT) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period
-
Ferritin values that average 200 to 800 micrograms/ liter (µg/L), inclusive, measured during the screening period. An average ferritin above 800 µg/L but no greater than 1200 µg/L is allowed if the average TSAT is 20% to no greater than 25%.
-
Except for vascular access surgery, subject has no hospitalization in previous three months for a significant illness that, in the opinion of the Investigator, confers a significant risk of hospitalization during the course of the study. No blood transfusions within the last 4 weeks are allowed.
-
Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal Investigator
Exclusion Criteria:
-
Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL
-
Subject with a current malignancy involving a site other than skin
-
Subject with a history of drug or alcohol abuse within the last six months
-
Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year)
-
Subject who the Principal Investigator considers will be placed at increased risk by the study procedures
-
Subject requiring hemodialysis more than 3 times per week on a regular basis.
-
Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study
-
Subject who is pregnant
-
Subject considered incompetent to give an informed consent
-
Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening
-
Subject with known HIV infection (if this is not known, no HIV testing will be performed)
-
Subject with cirrhosis of the liver based on histological criteria or clinical criteria (presence of ascites, esophageal varices, spider nevi, or history of hepatic encephalopathy). Subject with hepatitis C, in the absence of cirrhosis, is not excluded from participation in the study if ALT and AST levels are below 2 times the upper limit of normal consistently during the 2 months preceding enrollment
-
Subject with active tuberculosis, fungal, viral, or parasitic infection
-
Subject with active bacterial infection requiring antibiotic therapy
-
Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds (ms)
-
Subject with a history of hypokalemia, decompensated heart failure, or family history of Long QT Syndrome that in the Investigator's judgment poses a risk for Torsades de Pointe during the study
-
Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I, TABLE A)
-
Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®, Procrit®, or Aranesp®) per week
-
Subject has participated in another clinical trial within 30 days of signing Informed Consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Investigator | Tempe | Arizona | United States | 85284 |
| 2 | Investigator | Hacienda Heights | California | United States | 91745 |
| 3 | Investigator | Los Angeles | California | United States | 90059 |
| 4 | Investigator | Whittier | California | United States | 90603 |
| 5 | Investigative Site | Augusta | Georgia | United States | 30901 |
| 6 | Investigator | Meridian | Idaho | United States | 83642 |
| 7 | Investigator | Chicago | Illinois | United States | 60617 |
| 8 | Investigative Site | Louisville | Kentucky | United States | 40202-1718 |
| 9 | Investigator | New Orleans | Louisiana | United States | 70115 |
| 10 | Investigator | Springfield | Massachusetts | United States | 01107 |
| 11 | Investigative Site | Detroit | Michigan | United States | 48202 |
| 12 | Investigator | Hackensack | New Jersey | United States | 07601 |
| 13 | Investigator | Brooklyn | New York | United States | 11212 |
| 14 | Investigator | Great Neck | New York | United States | 11021 |
| 15 | Investigator | Mineola | New York | United States | 11501 |
| 16 | Investigator | New York | New York | United States | 10013 |
| 17 | Investigator | Ridgewood | New York | United States | 11385 |
| 18 | Investigator | Winston-Salem | North Carolina | United States | 27103 |
| 19 | Investigative Site | Canton | Ohio | United States | 44718 |
| 20 | Investigator | Cincinnati | Ohio | United States | 45229 |
| 21 | Investigative Site | Hershey | Pennsylvania | United States | 17033 |
| 22 | Investigator | Arlington | Texas | United States | 76011 |
| 23 | Investigator | Fort Worth | Texas | United States | 76105 |
| 24 | Investigator | McAllen | Texas | United States | 78503 |
| 25 | Investigator | San Antonio | Texas | United States | 78207 |
| 26 | Investigator | Arlington | Virginia | United States | 22206 |
| 27 | Investigator | Seattle | Washington | United States | 92133 |
| 28 | Investigative Site | Edmonton | Alberta | Canada | T6G2B7 |
Sponsors and Collaborators
- Rockwell Medical Technologies, Inc.
Investigators
- Study Director: Richard Yocum, MD, Rockwell Medical Technologies
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00548249
Other Study ID Numbers:
- RMTI-SFP-2
First Posted:
Oct 23, 2007
Last Update Posted:
Dec 2, 2020
Last Verified:
Nov 1, 2020
Keywords provided by Rockwell Medical Technologies, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 131 patients randomized and dosed between 27 Aug 2007 and 28 Apr 2009, across 29 study sites in U.S. and Canada. |
|---|---|
| Pre-assignment Detail | No run-in or transition. |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Period Title: Overall Study | |||||
| STARTED | 26 | 26 | 29 | 22 | 28 |
| COMPLETED | 10 | 13 | 9 | 9 | 7 |
| NOT COMPLETED | 16 | 13 | 20 | 13 | 21 |
Baseline Characteristics
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate | Total |
|---|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | Total of all reporting groups |
| Overall Participants | 26 | 26 | 29 | 22 | 28 | 131 |
| Age (Count of Participants) | ||||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
20
76.9%
|
19
73.1%
|
19
65.5%
|
15
68.2%
|
14
50%
|
87
66.4%
|
| >=65 years |
6
23.1%
|
7
26.9%
|
10
34.5%
|
7
31.8%
|
14
50%
|
44
33.6%
|
| Age (years) [Mean (Standard Deviation) ] | ||||||
| Mean (Standard Deviation) [years] |
57.7
(10.68)
|
57.3
(15.48)
|
57.3
(13.97)
|
57.9
(12.79)
|
59.8
(16.96)
|
58
(14.07)
|
| Sex: Female, Male (Count of Participants) | ||||||
| Female |
8
30.8%
|
11
42.3%
|
13
44.8%
|
7
31.8%
|
11
39.3%
|
50
38.2%
|
| Male |
18
69.2%
|
15
57.7%
|
16
55.2%
|
15
68.2%
|
17
60.7%
|
81
61.8%
|
| Region of Enrollment (participants) [Number] | ||||||
| United States |
22
84.6%
|
24
92.3%
|
25
86.2%
|
21
95.5%
|
25
89.3%
|
117
89.3%
|
| Canada |
4
15.4%
|
2
7.7%
|
4
13.8%
|
1
4.5%
|
3
10.7%
|
14
10.7%
|
Outcome Measures
| Title | Percent of Subjects Whose Hemoglobin (Hgb) Decreases by a Total of 1.0 Grams/ Deciliter (g/dL) (or More) From Baseline on Each of Two Successive Measurements. |
|---|---|
| Description | Efficacy of a Soluble Ferric Pyrophosphate (SFP)-containing dialysate solution in maintaining physiological iron levels during chronic HD, as measured by the percent of subjects whose hgb decreases by a total of 1.0 g/dL (or more) from baseline on each of two successive measurements. Hemoglobin was obtained weekly at the mid-week dialysis treatments and compared to baseline value (average of two hgb measurements obtained at the two consecutive baseline visits prior to randomization). |
| Time Frame | up to 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| Number [Percent of subjects] |
5
|
6
|
5
|
4
|
10
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 5 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards model | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.999 |
| Comments | p-value not adjusted for multiple comparisons | |
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.00 | |
| Confidence Interval |
(2-Sided) 95% 0.30 to 3.32 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 10 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.807 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.17 | |
| Confidence Interval |
(2-Sided) 95% 0.33 to 4.09 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 12 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.748 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 0.80 | |
| Confidence Interval |
(2-Sided) 95% 0.21 to 3.02 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 15 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.299 |
| Comments | ||
| Method | Log Rank | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Cox Proportional Hazard |
| Estimated Value | 1.77 | |
| Confidence Interval |
(2-Sided) 95% 0.60 to 5.19 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change From Baseline in Hemoglobin (Hgb) |
|---|---|
| Description | |
| Time Frame | two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks) |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| Mean (Standard Deviation) [grams/ deciliter (g/dL)] |
-0.177
(1.1151)
|
0.258
(1.4643)
|
0.462
(1.2214)
|
0.173
(1.5806)
|
-0.018
(1.2532)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 5 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | Each dose was compared to placebo using an ANOVA model with treatment as the effect. | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.234 |
| Comments | Threshold for statistical significance p < 0.05 | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 10 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | Each dose was compared to placebo using an ANOVA model with treatment as the effect | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.049 |
| Comments | Threshold for statistical significance p < 0.05 | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 12 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | Each dose was compared to placebo using an ANOVA model with treatment as the effect | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.375 |
| Comments | Threshold for statistical significance p < 0.05 | |
| Method | ANOVA | |
| Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | 0 µg Iron/dL of Dialysate, 15 µg Iron/dL of Dialysate |
|---|---|---|
| Comments | Each dose was compared to placebo using an ANOVA model with treatment as the effect | |
| Type of Statistical Test | Superiority or Other (legacy) | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.625 |
| Comments | Threshold for statistical significance p < 0.05 | |
| Method | ANOVA | |
| Comments | ||
| Title | Time in Days for Hgb to Decrease by a Total of > = 1.0 g/dL From Baseline on Each of Two Successive Measurements in Each Treatment Group. |
|---|---|
| Description | Kaplan-Meier Estimate of Time to First Hgb Decrease by >= 1.0 g/dL |
| Time Frame | Up to 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication. Because of the small number of patients reaching the endpoint of decrease in Hgb >= 1.0 g/dL, the Kaplan-Meier analysis could not estimate the number of days for at least one treatment group for the 50th percentile and higher. |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| 5th Percentile |
59
(0.3267)
|
24
(0.6674)
|
10
(0.4402)
|
31
(0.3697)
|
31
(0.6609)
|
| 10th Percentile |
94
|
31
|
106
|
45
|
31
|
| 15th Percentile |
94
|
66
|
106
|
115
|
38
|
| 20th Percentile |
115
|
87
|
106
|
115
|
80
|
| 25th Percentile |
115
|
108
|
115
|
150
|
94
|
| Title | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. |
|---|---|
| Description | Efficacy of SFP administration in dialysate solution as measured by Chr values every four weeks, and at the end of the Subject's Treatment (up to 26 weeks). |
| Time Frame | Every 4 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| Baseline Reticulocyte Hemoglobin |
32.55
(2.084)
|
32.98
(1.763)
|
32.86
(3.192)
|
32.34
(2.975)
|
32.64
(1.858)
|
| Reticulocyte Hemoglobin/ Week 1 |
32.42
(2.852)
|
32.58
(1.932)
|
32.69
(3.019)
|
31.87
(2.963)
|
32.40
(2.006)
|
| Reticulocyte Hemoglobin/ Week 4 |
32.00
(2.668)
|
32.27
(2.090)
|
32.69
(2.931)
|
31.82
(2.515)
|
32.05
(1.837)
|
| Reticulocyte Hemoglobin/ Week 8 |
32.14
(2.664)
|
32.28
(2.135)
|
32.75
(2.985)
|
31.75
(2.473)
|
32.35
(1.917)
|
| Reticulocyte Hemoglobin/ Week 12 |
31.83
(2.347)
|
32.13
(1.792)
|
32.78
(1.560)
|
31.82
(3.150)
|
32.48
(1.894)
|
| Reticulocyte Hemoglobin/ Week 16 |
31.45
(2.546)
|
31.95
(1.866)
|
33.05
(2.396)
|
31.86
(3.410)
|
32.25
(2.382)
|
| Reticulocyte Hemoglobin/ Week 20 |
31.13
(2.172)
|
31.81
(1.860)
|
32.81
(2.328)
|
30.68
(2.026)
|
31.64
(1.338)
|
| Reticulocyte Hemoglobin/ Week 24 |
30.93
(2.127)
|
31.85
(1.820)
|
32.08
(2.680)
|
30.53
(2.071)
|
31.40
(1.949)
|
| Reticulocyte Hemoglobin/ Week 26 |
30.78
(2.638)
|
31.32
(2.404)
|
32.20
(2.372)
|
30.72
(2.515)
|
30.43
(2.600)
|
| Reticulocyte Hemoglobin/ End of Trial |
30.06
(1.841)
|
31.50
(2.348)
|
31.46
(2.352)
|
30.55
(2.523)
|
30.11
(2.361)
|
| Reticulocyte Hemoglobin/ Final Evaluation |
31.85
(2.796)
|
31.68
(2.386)
|
32.19
(3.026)
|
31.65
(3.409)
|
32.13
(2.246)
|
| Title | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. |
|---|---|
| Description | |
| Time Frame | At each dialysis session for up to 26 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| Number [Subjects] |
2
|
1
|
2
|
0
|
1
|
| Title | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. |
|---|---|
| Description | |
| Time Frame | two separate sessions measured one week apart. |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication |
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate |
|---|---|---|---|---|---|
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week |
| Measure Participants | 26 | 26 | 29 | 22 | 28 |
| Number [Subjects] |
6
|
6
|
9
|
7
|
8
|
Adverse Events
| Time Frame | Up to 26 weeks | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate | |||||
| Arm/Group Description | Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | |||||
All Cause Mortality |
||||||||||
| 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 7/26 (26.9%) | 2/26 (7.7%) | 5/29 (17.2%) | 7/22 (31.8%) | 5/28 (17.9%) | |||||
| Cardiac disorders | ||||||||||
| Angina pectoris | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Bradycardia | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Cardio-respiratory arrest | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Coronary artery disease | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Eye disorders | ||||||||||
| Eyelid oedema | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| Gastric ulcer | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Gastrointestinal haemorrhage | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Impaired gastric emptying | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Vomiting | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Hepatobiliary disorders | ||||||||||
| Hepatic failure | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Infections and infestations | ||||||||||
| Catheter bacteraemia | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Cellulitis | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Clostridium difficile colitis | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Cystitis | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Necrotising fasciitis | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Osteomyelitis | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Staphylococcal bacteraemia | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Graft dysfunction | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Fluid overload | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||
| Renal cell carcinoma | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Nervous system disorders | ||||||||||
| Cognitive disorder | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Thalamic infarction | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 2/22 (9.1%) | 0/28 (0%) | |||||
| Chronic obstructive pulmonary | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Pleural effusion | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Pulmonary oedema | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Leukocytoclastic vasculitis | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Vascular disorders | ||||||||||
| Aortic stenosis | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Hypertensive emergency | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| 0 µg Iron/dL of Dialysate | 5 µg Iron/dL of Dialysate | 10 µg Iron/dL of Dialysate | 12 µg Iron/dL of Dialysate | 15 µg Iron/dL of Dialysate | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 20/26 (76.9%) | 17/26 (65.4%) | 20/29 (69%) | 16/22 (72.7%) | 17/28 (60.7%) | |||||
| Cardiac disorders | ||||||||||
| Tachycardia | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Gastrointestinal disorders | ||||||||||
| Diarrhoea | 3/26 (11.5%) | 3/26 (11.5%) | 7/29 (24.1%) | 2/22 (9.1%) | 4/28 (14.3%) | |||||
| Nausea | 4/26 (15.4%) | 3/26 (11.5%) | 2/29 (6.9%) | 6/22 (27.3%) | 4/28 (14.3%) | |||||
| Vomiting | 3/26 (11.5%) | 3/26 (11.5%) | 2/29 (6.9%) | 4/22 (18.2%) | 1/28 (3.6%) | |||||
| Constipation | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 2/22 (9.1%) | 2/28 (7.1%) | |||||
| Abdominal pain upper | 1/26 (3.8%) | 0/26 (0%) | 2/29 (6.9%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Dysphagia | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 2/22 (9.1%) | 0/28 (0%) | |||||
| Toothache | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| General disorders | ||||||||||
| Pyrexia | 1/26 (3.8%) | 3/26 (11.5%) | 0/29 (0%) | 2/22 (9.1%) | 1/28 (3.6%) | |||||
| Oedema peripheral | 5/26 (19.2%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Fatigue | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Non-cardiac chest pain | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Asthenia | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Chest discomfort | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Chest pain | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Chills | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 2/22 (9.1%) | 0/28 (0%) | |||||
| Feeling hot | 0/26 (0%) | 1/26 (3.8%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Immune system disorders | ||||||||||
| Seasonal allergy | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Infections and infestations | ||||||||||
| Upper respiratory tract infection | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 3/22 (13.6%) | 1/28 (3.6%) | |||||
| Bacteraemia | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 2/28 (7.1%) | |||||
| Bronchitis | 0/26 (0%) | 2/26 (7.7%) | 0/29 (0%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Cellulitis | 0/26 (0%) | 3/26 (11.5%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Nasopharyngitis | 0/26 (0%) | 1/26 (3.8%) | 1/29 (3.4%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Urinary tract infection | 1/26 (3.8%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Wound infection | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Contusion | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| Procedural hypotension | 2/26 (7.7%) | 4/26 (15.4%) | 5/29 (17.2%) | 2/22 (9.1%) | 4/28 (14.3%) | |||||
| Thrombosis in device | 1/26 (3.8%) | 1/26 (3.8%) | 0/29 (0%) | 2/22 (9.1%) | 1/28 (3.6%) | |||||
| Vascular graft complication | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 1/28 (3.6%) | |||||
| Arteriovenous fistula occlusion | 0/26 (0%) | 1/26 (3.8%) | 1/29 (3.4%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Procedural hypertension | 0/26 (0%) | 0/26 (0%) | 3/29 (10.3%) | 0/22 (0%) | 0/28 (0%) | |||||
| Thermal burn | 0/26 (0%) | 0/26 (0%) | 3/29 (10.3%) | 0/22 (0%) | 0/28 (0%) | |||||
| Excoriation | 1/26 (3.8%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Fall | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Procedural pain | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Skin laceration | 1/26 (3.8%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Wound | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Investigations | ||||||||||
| Serum ferritin increased | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Blood iron decreased | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Iron binding capacity unsaturated decreased | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| Hyperglycaemia | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Decreased appetite | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Gout | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 2/28 (7.1%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| Muscle spasms | 4/26 (15.4%) | 0/26 (0%) | 4/29 (13.8%) | 3/22 (13.6%) | 1/28 (3.6%) | |||||
| Pain in extremity | 3/26 (11.5%) | 2/26 (7.7%) | 1/29 (3.4%) | 2/22 (9.1%) | 3/28 (10.7%) | |||||
| Arthralgia | 1/26 (3.8%) | 2/26 (7.7%) | 2/29 (6.9%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Back pain | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Musculoskeletal pain | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Muscular weakness | 0/26 (0%) | 0/26 (0%) | 0/29 (0%) | 2/22 (9.1%) | 0/28 (0%) | |||||
| Neck pain | 2/26 (7.7%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Nervous system disorders | ||||||||||
| Headache | 5/26 (19.2%) | 2/26 (7.7%) | 5/29 (17.2%) | 3/22 (13.6%) | 2/28 (7.1%) | |||||
| Dizziness | 2/26 (7.7%) | 3/26 (11.5%) | 4/29 (13.8%) | 1/22 (4.5%) | 2/28 (7.1%) | |||||
| Psychiatric disorders | ||||||||||
| Insomnia | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| Dyspnoea | 3/26 (11.5%) | 1/26 (3.8%) | 3/29 (10.3%) | 4/22 (18.2%) | 2/28 (7.1%) | |||||
| Pharyngolaryngeal pain | 3/26 (11.5%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 0/28 (0%) | |||||
| Wheezing | 1/26 (3.8%) | 0/26 (0%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| Pruritus | 0/26 (0%) | 0/26 (0%) | 1/29 (3.4%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Skin ulcer | 0/26 (0%) | 1/26 (3.8%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Swelling face | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 1/22 (4.5%) | 0/28 (0%) | |||||
| Rash | 0/26 (0%) | 1/26 (3.8%) | 1/29 (3.4%) | 0/22 (0%) | 0/28 (0%) | |||||
| Vascular disorders | ||||||||||
| Hypertension | 0/26 (0%) | 0/26 (0%) | 2/29 (6.9%) | 0/22 (0%) | 1/28 (3.6%) | |||||
| Hypotension | 1/26 (3.8%) | 0/26 (0%) | 0/29 (0%) | 0/22 (0%) | 1/28 (3.6%) | |||||
Limitations/Caveats
AE tabulation best summarizes the primary safety outcome.
Lack of accuracy in analytical method for measuring iron concentration in inflow and outflow from dialysis machine impaired ability to assess secondary outcome of amount SFP transferred.
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Richard C. Yocum, MD |
|---|---|
| Organization | Rockwell Medical |
| Phone | 858-229-8585 |
| ryocum@rockwellmed.com |
Responsible Party:
Rockwell Medical Technologies, Inc.
ClinicalTrials.gov Identifier:
NCT00548249
Other Study ID Numbers:
- RMTI-SFP-2
First Posted:
Oct 23, 2007
Last Update Posted:
Dec 2, 2020
Last Verified:
Nov 1, 2020