End-Stage Renal Disease (ESRD)
Conditions
Keywords
Subjects with ESRD receiving chronic Hemodialysis
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.
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.
Interventions
DEVICEStandard Bicarbonate Solution
Patients received 0 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Patients received 5 micrograms (µg) of iron/ decilited (dL) of dialysate during dialysis 3 times/week for up to 26 weeks.
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selected Inclusion Criteria: 1. Adult subject ≥ 18 years of age undergoing chronic hemodialysis for end-stage renal disease (ESRD) three times a week 2. 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 3. Transferrin Saturation (TSAT) values that average 20% or more, but not exceeding 35%, prior to dialysis measured during the screening period 4. 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%. 5. 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. 6. Subject has an adequate dialyzer blood flow rate that is acceptable to the Principal Investigator
Exclusion criteria
1. Hemoglobin (Hgb) values on two successive baseline/screening measurements that average ≥ 11.6g/dL 2. Subject with a current malignancy involving a site other than skin 3. Subject with a history of drug or alcohol abuse within the last six months 4. Subject believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year) 5. Subject who the Principal Investigator considers will be placed at increased risk by the study procedures 6. Subject requiring hemodialysis more than 3 times per week on a regular basis. 7. Subject who is unable to discontinue oral iron or intravenous iron supplements for the duration of the study 8. Subject who is pregnant 9. Subject considered incompetent to give an informed consent 10. Subject with a positive test for Hepatitis B Surface Antigen within the past 30 days or during screening 11. Subject with known HIV infection (if this is not known, no HIV testing will be performed) 12. 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 13. Subject with active tuberculosis, fungal, viral, or parasitic infection 14. Subject with active bacterial infection requiring antibiotic therapy 15. Subject with pre-dialysis Corrected Q-wave to T-wave (QTc) interval ≥ 470 milliseconds (ms) 16. 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 17. Subject using concomitant medications known to prolong QT/QTc interval (See Appendix I, TABLE A) 18. Subject receiving more than 60,000 units or 120 micrograms of erythropoietin (Epogen®, Procrit®, or Aranesp®) per week 19. Subject has participated in another clinical trial within 30 days of signing Informed Consent
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. | — |
Countries
Canada, United States
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 details
No run-in or transition.
Participants by arm
| Arm | Count |
|---|---|
| 0 µg Iron/dL of Dialysate Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 26 |
| 5 µg Iron/dL of Dialysate 5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 26 |
| 10 µg Iron/dL of Dialysate 10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 29 |
| 12 µg Iron/dL of Dialysate 12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 22 |
| 15 µg Iron/dL of Dialysate 15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week | 28 |
| Total | 131 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 | 0 | 1 | 1 |
| Overall Study | Corrected Q-wave T-wave (QTc) increase | 0 | 1 | 0 | 0 | 1 |
| Overall Study | Erythropoietin (ESA)Dose Change Required | 0 | 0 | 1 | 2 | 2 |
| Overall Study | Hemoglobin (Hgb) >= 12.6 g/dL | 1 | 1 | 1 | 1 | 0 |
| Overall Study | Hemoglobin (Hgb) decrease >=1.0 g/dL | 3 | 4 | 4 | 2 | 4 |
| Overall Study | Miscellaneous | 2 | 3 | 2 | 0 | 2 |
| Overall Study | Post-dialysis high TSAT or low UIBC | 0 | 0 | 1 | 3 | 2 |
| Overall Study | Pre-dialysis (Pre-HD) TSAT >=50% | 0 | 0 | 2 | 1 | 4 |
| Overall Study | Prolonged hospitalization | 0 | 0 | 2 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 1 | 4 | 0 | 3 |
| Overall Study | Sponsor's request | 0 | 0 | 0 | 1 | 0 |
| Overall Study | Transferrin Saturation (TSAT) <20% | 5 | 1 | 3 | 1 | 2 |
| Overall Study | Withdrawal by Subject | 2 | 0 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 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 |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 7 Participants | 10 Participants | 7 Participants | 14 Participants | 44 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants | 19 Participants | 19 Participants | 15 Participants | 14 Participants | 87 Participants |
| Age, Continuous | 57.7 years STANDARD_DEVIATION 10.68 | 57.3 years STANDARD_DEVIATION 15.48 | 57.3 years STANDARD_DEVIATION 13.97 | 57.9 years STANDARD_DEVIATION 12.79 | 59.8 years STANDARD_DEVIATION 16.96 | 58 years STANDARD_DEVIATION 14.07 |
| Region of Enrollment Canada | 4 participants | 2 participants | 4 participants | 1 participants | 3 participants | 14 participants |
| Region of Enrollment United States | 22 participants | 24 participants | 25 participants | 21 participants | 25 participants | 117 participants |
| Sex: Female, Male Female | 8 Participants | 11 Participants | 13 Participants | 7 Participants | 11 Participants | 50 Participants |
| Sex: Female, Male Male | 18 Participants | 15 Participants | 16 Participants | 15 Participants | 17 Participants | 81 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 20 / 26 | 17 / 26 | 20 / 29 | 16 / 22 | 17 / 28 |
| serious Total, serious adverse events | 7 / 26 | 2 / 26 | 5 / 29 | 7 / 22 | 5 / 28 |
Outcome results
Primary
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.
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
Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0 µg Iron/dL of Dialysate | 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. | 5 Percent of subjects |
| 5 µg Iron/dL of Dialysate | 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. | 6 Percent of subjects |
| 10 µg Iron/dL of Dialysate | 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. | 5 Percent of subjects |
| 12 µg Iron/dL of Dialysate | 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. | 4 Percent of subjects |
| 15 µg Iron/dL of Dialysate | 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. | 10 Percent of subjects |
p-value: 0.80795% CI: [0.33, 4.09]Log Rank
Comparison: Hazard ratio with 95% confidence intervals comparing each SFP treatment group to placebo, and p-value from cox proportional hazards modelp-value: 0.99995% CI: [0.3, 3.32]Log Rank
p-value: 0.74895% CI: [0.21, 3.02]Log Rank
p-value: 0.29995% CI: [0.6, 5.19]Log Rank
Secondary
Change From Baseline in Hemoglobin (Hgb)
Time frame: two time points: baseline and final evaluation (last post baseline assessment, up to 26 weeks)
Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 0 µg Iron/dL of Dialysate | Change From Baseline in Hemoglobin (Hgb) | -0.177 grams/ deciliter (g/dL) | Standard Deviation 1.1151 |
| 5 µg Iron/dL of Dialysate | Change From Baseline in Hemoglobin (Hgb) | 0.258 grams/ deciliter (g/dL) | Standard Deviation 1.4643 |
| 10 µg Iron/dL of Dialysate | Change From Baseline in Hemoglobin (Hgb) | 0.462 grams/ deciliter (g/dL) | Standard Deviation 1.2214 |
| 12 µg Iron/dL of Dialysate | Change From Baseline in Hemoglobin (Hgb) | 0.173 grams/ deciliter (g/dL) | Standard Deviation 1.5806 |
| 15 µg Iron/dL of Dialysate | Change From Baseline in Hemoglobin (Hgb) | -0.018 grams/ deciliter (g/dL) | Standard Deviation 1.2532 |
Comparison: Each dose was compared to placebo using an ANOVA model with treatment as the effect.p-value: 0.234ANOVA
Comparison: Each dose was compared to placebo using an ANOVA model with treatment as the effectp-value: 0.049ANOVA
Comparison: Each dose was compared to placebo using an ANOVA model with treatment as the effectp-value: 0.375ANOVA
Comparison: Each dose was compared to placebo using an ANOVA model with treatment as the effectp-value: 0.625ANOVA
Secondary
Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart.
Time frame: two separate sessions measured one week apart.
Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0 µg Iron/dL of Dialysate | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. | 6 Subjects |
| 5 µg Iron/dL of Dialysate | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. | 6 Subjects |
| 10 µg Iron/dL of Dialysate | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. | 9 Subjects |
| 12 µg Iron/dL of Dialysate | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. | 7 Subjects |
| 15 µg Iron/dL of Dialysate | Number of Subjects With a Rise in Hemoglobin (Hgb) to 12.6 g/dL or More on Two Separate Occasions Measured One Week Apart. | 8 Subjects |
Secondary
Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group.
Time frame: At each dialysis session for up to 26 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 0 µg Iron/dL of Dialysate | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. | 2 Subjects |
| 5 µg Iron/dL of Dialysate | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. | 1 Subjects |
| 10 µg Iron/dL of Dialysate | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. | 2 Subjects |
| 12 µg Iron/dL of Dialysate | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. | 0 Subjects |
| 15 µg Iron/dL of Dialysate | Number of Subjects With Infection Episodes Requiring Antibiotic or Anti-fungal Therapy in Each Treatment Group. | 1 Subjects |
Secondary
Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment.
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
Population: Modified intent-to-treat population, consisting of all subjects who received any amount of randomized study medication
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 4 | 32.00 pg | Standard Deviation 2.668 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 12 | 31.83 pg | Standard Deviation 2.347 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 8 | 32.14 pg | Standard Deviation 2.664 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Final Evaluation | 31.85 pg | Standard Deviation 2.796 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ End of Trial | 30.06 pg | Standard Deviation 1.841 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 26 | 30.78 pg | Standard Deviation 2.638 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 1 | 32.42 pg | Standard Deviation 2.852 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Baseline Reticulocyte Hemoglobin | 32.55 pg | Standard Deviation 2.084 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 24 | 30.93 pg | Standard Deviation 2.127 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 20 | 31.13 pg | Standard Deviation 2.172 |
| 0 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 16 | 31.45 pg | Standard Deviation 2.546 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 4 | 32.27 pg | Standard Deviation 2.09 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Baseline Reticulocyte Hemoglobin | 32.98 pg | Standard Deviation 1.763 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 1 | 32.58 pg | Standard Deviation 1.932 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 8 | 32.28 pg | Standard Deviation 2.135 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 12 | 32.13 pg | Standard Deviation 1.792 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 16 | 31.95 pg | Standard Deviation 1.866 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 20 | 31.81 pg | Standard Deviation 1.86 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 24 | 31.85 pg | Standard Deviation 1.82 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 26 | 31.32 pg | Standard Deviation 2.404 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ End of Trial | 31.50 pg | Standard Deviation 2.348 |
| 5 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Final Evaluation | 31.68 pg | Standard Deviation 2.386 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 20 | 32.81 pg | Standard Deviation 2.328 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ End of Trial | 31.46 pg | Standard Deviation 2.352 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Final Evaluation | 32.19 pg | Standard Deviation 3.026 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 1 | 32.69 pg | Standard Deviation 3.019 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 24 | 32.08 pg | Standard Deviation 2.68 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 4 | 32.69 pg | Standard Deviation 2.931 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 16 | 33.05 pg | Standard Deviation 2.396 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 12 | 32.78 pg | Standard Deviation 1.56 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 26 | 32.20 pg | Standard Deviation 2.372 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 8 | 32.75 pg | Standard Deviation 2.985 |
| 10 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Baseline Reticulocyte Hemoglobin | 32.86 pg | Standard Deviation 3.192 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 26 | 30.72 pg | Standard Deviation 2.515 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 12 | 31.82 pg | Standard Deviation 3.15 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 16 | 31.86 pg | Standard Deviation 3.41 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 1 | 31.87 pg | Standard Deviation 2.963 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 20 | 30.68 pg | Standard Deviation 2.026 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 24 | 30.53 pg | Standard Deviation 2.071 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Baseline Reticulocyte Hemoglobin | 32.34 pg | Standard Deviation 2.975 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Final Evaluation | 31.65 pg | Standard Deviation 3.409 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 4 | 31.82 pg | Standard Deviation 2.515 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 8 | 31.75 pg | Standard Deviation 2.473 |
| 12 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ End of Trial | 30.55 pg | Standard Deviation 2.523 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 26 | 30.43 pg | Standard Deviation 2.6 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 1 | 32.40 pg | Standard Deviation 2.006 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 12 | 32.48 pg | Standard Deviation 1.894 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 8 | 32.35 pg | Standard Deviation 1.917 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 4 | 32.05 pg | Standard Deviation 1.837 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Final Evaluation | 32.13 pg | Standard Deviation 2.246 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ End of Trial | 30.11 pg | Standard Deviation 2.361 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 24 | 31.40 pg | Standard Deviation 1.949 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Baseline Reticulocyte Hemoglobin | 32.64 pg | Standard Deviation 1.858 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 20 | 31.64 pg | Standard Deviation 1.338 |
| 15 µg Iron/dL of Dialysate | Reticulocyte Hemoglobin (CHr) Values Every Four Weeks, and at the End of the Subject's Treatment. | Reticulocyte Hemoglobin/ Week 16 | 32.25 pg | Standard Deviation 2.382 |
Secondary
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.
Kaplan-Meier Estimate of Time to First Hgb Decrease by \>= 1.0 g/dL
Time frame: Up to 26 weeks
Population: 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 | Measure | Group | Value (NUMBER) | Dispersion |
|---|---|---|---|---|
| 0 µg Iron/dL of Dialysate | 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. | 20th Percentile | 115 Days | — |
| 0 µg Iron/dL of Dialysate | 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. | 15th Percentile | 94 Days | — |
| 0 µg Iron/dL of Dialysate | 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. | 5th Percentile | 59 Days | 0.3267 |
| 0 µg Iron/dL of Dialysate | 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. | 25th Percentile | 115 Days | — |
| 0 µg Iron/dL of Dialysate | 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. | 10th Percentile | 94 Days | — |
| 5 µg Iron/dL of Dialysate | 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. | 5th Percentile | 24 Days | 0.6674 |
| 5 µg Iron/dL of Dialysate | 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. | 15th Percentile | 66 Days | — |
| 5 µg Iron/dL of Dialysate | 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. | 20th Percentile | 87 Days | — |
| 5 µg Iron/dL of Dialysate | 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. | 10th Percentile | 31 Days | — |
| 5 µg Iron/dL of Dialysate | 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. | 25th Percentile | 108 Days | — |
| 10 µg Iron/dL of Dialysate | 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. | 15th Percentile | 106 Days | — |
| 10 µg Iron/dL of Dialysate | 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. | 5th Percentile | 10 Days | 0.4402 |
| 10 µg Iron/dL of Dialysate | 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. | 10th Percentile | 106 Days | — |
| 10 µg Iron/dL of Dialysate | 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. | 20th Percentile | 106 Days | — |
| 10 µg Iron/dL of Dialysate | 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. | 25th Percentile | 115 Days | — |
| 12 µg Iron/dL of Dialysate | 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. | 25th Percentile | 150 Days | — |
| 12 µg Iron/dL of Dialysate | 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. | 5th Percentile | 31 Days | 0.3697 |
| 12 µg Iron/dL of Dialysate | 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. | 20th Percentile | 115 Days | — |
| 12 µg Iron/dL of Dialysate | 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. | 15th Percentile | 115 Days | — |
| 12 µg Iron/dL of Dialysate | 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. | 10th Percentile | 45 Days | — |
| 15 µg Iron/dL of Dialysate | 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. | 15th Percentile | 38 Days | — |
| 15 µg Iron/dL of Dialysate | 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. | 20th Percentile | 80 Days | — |
| 15 µg Iron/dL of Dialysate | 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. | 5th Percentile | 31 Days | 0.6609 |
| 15 µg Iron/dL of Dialysate | 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. | 25th Percentile | 94 Days | — |
| 15 µg Iron/dL of Dialysate | 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. | 10th Percentile | 31 Days | — |