Renal Failure Chronic Requiring Hemodialysis
Conditions
Keywords
End Stage Renal Disease, Hemodialysis, SFP, Hemodialysis-dependent chronic renal failure
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).
Detailed description
Screening: 2-3 weeks prior to enrollment in Stage 1. Stage 1 (Run-In): 1-4weeks depending on qualification for Stage 2. Stage 2 (Randomized Blinded Treatment): 12 months unless withdrawn prematurely. Stage 3 (Open-Label Treatment): The duration of Stage 2 plus Stage 3 is intended to be 18 months regardless of treatment assignment in Stage 2.
Interventions
Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
DEVICEStandard dialysate
Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
Sponsors
Rockwell Medical Technologies, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean | Hgb measured weekly; up to 48 weeks from date of randomization | Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error. |
| Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | Hgb measured weekly; up to 48 weeks from date of randomization | Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | Up to 48 weeks from date of randomization | The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
| Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion | Up to 48 weeks from date of randomization | The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2. |
| Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused | Up to 48 weeks from date of randomization | The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2. |
| Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | up to 48 weeks from date of randomization | A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT). |
| Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Up to 48 weeks from date of randomization | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified. |
| Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | Up to 48 weeks from date of randomization | The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
| Change From Baseline to End-of-Treatment (EoT) in Ferritin | Up to 48 weeks from date of randomization | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin |
| Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | Up to 48 weeks from date of randomization | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin |
| Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | Up to 48 weeks from date of randomization | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) |
| Variability of Hemoglobin Concentration: Temporal Trend | up to 48 weeks from date of randomization | The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2. |
| Variability of Hemoglobin Concentration: Residual Standard Deviation | up to 48 weeks from date of randomization | The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2. |
| Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | Up to 48 weeks from date of randomization | The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) |
| Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | Up to 48 weeks from date of randomization | The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Soluble Ferric Pyrophosphate (SFP) in Dialysate 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. | 147 |
| Standard Dialysate (Placebo) 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. | 147 |
| Total | 294 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 2 |
| Overall Study | blood transfusion | 5 | 5 |
| Overall Study | Death | 5 | 3 |
| Overall Study | ineligible | 6 | 3 |
| Overall Study | kidney transplant | 3 | 1 |
| Overall Study | moved/changed dialysis | 2 | 4 |
| Overall Study | non-protocol change to ESA or IV iron | 14 | 6 |
| Overall Study | Physician Decision | 2 | 1 |
| Overall Study | Protocol Violation | 5 | 2 |
| Overall Study | sponsor decision | 1 | 3 |
| Overall Study | study drug withheld > 12 wks | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 4 |
Baseline characteristics
| Characteristic | Total | Soluble Ferric Pyrophosphate (SFP) in Dialysate | Standard Dialysate (Placebo) |
|---|---|---|---|
| Age, Continuous | 58.5 years STANDARD_DEVIATION 13.54 | 58.1 years STANDARD_DEVIATION 12.68 | 59.0 years STANDARD_DEVIATION 14.38 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 69 Participants | 33 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 225 Participants | 114 Participants | 111 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.40 centimeters STANDARD_DEVIATION 10.093 | 168.80 centimeters STANDARD_DEVIATION 10.238 | 170.01 centimeters STANDARD_DEVIATION 9.944 |
| Post-dialysis weight | 85.86 kilograms STANDARD_DEVIATION 22.857 | 86.64 kilograms STANDARD_DEVIATION 22.27 | 85.09 kilograms STANDARD_DEVIATION 23.474 |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 118 Participants | 64 Participants | 54 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 156 Participants | 73 Participants | 83 Participants |
| Region of Enrollment Canada | 43 participants | 19 participants | 24 participants |
| Region of Enrollment United States | 251 participants | 128 participants | 123 participants |
| Sex: Female, Male Female | 119 Participants | 65 Participants | 54 Participants |
| Sex: Female, Male Male | 175 Participants | 82 Participants | 93 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 93 / 145 | 89 / 143 | 179 / 214 |
| serious Total, serious adverse events | 36 / 145 | 44 / 143 | 83 / 214 |
Outcome results
Primary
Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Value is expressed as least-squares mean, along with standard error.
Time frame: Hgb measured weekly; up to 48 weeks from date of randomization
Population: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean | -0.5 grams per liter | Standard Error 1.08 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean | -4.0 grams per liter | Standard Error 1.09 |
p-value: 0.011ANCOVA
Primary
Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin
Mean change from baseline Hgb (the average of the three most recent Hgb values preceding randomization) assessments during the last one-sixth of the treatment period for patients who prematurely withdraw from study treatment, but will include a minimum of at least the last two Hgb values. Values expressed are mean baseline and end-of-treatment Hgb, along with the mean difference (standard deviation).
Time frame: Hgb measured weekly; up to 48 weeks from date of randomization
Population: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dose hemoglobin value measured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | End-of-Treatment Hemoglobin | 108.7 grams per liter | Standard Deviation 13.81 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | Baseline Hemoglobin | 109.6 grams per liter | Standard Deviation 6.09 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | Mean Change in Hemoglobin from at End-of- | -0.9 grams per liter | Standard Deviation 11.76 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | Baseline Hemoglobin | 109.3 grams per liter | Standard Deviation 6.25 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | End-of-Treatment Hemoglobin | 104.9 grams per liter | Standard Deviation 13.33 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hemoglobin | Mean Change in Hemoglobin from at End-of- | -4.5 grams per liter | Standard Deviation 11.71 |
Secondary
Change From Baseline to End-of-Treatment (EoT) in Ferritin
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Ferritin
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Ferritin | Baseline Ferritin | 513.6 micrograms per liter | Standard Deviation 201.37 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Ferritin | EoT Ferritin | 446.5 micrograms per liter | Standard Deviation 225.33 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Ferritin | Ferritin Change from Baseline to EoT | -67.1 micrograms per liter | Standard Deviation 164.39 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Ferritin | Baseline Ferritin | 479.8 micrograms per liter | Standard Deviation 201.52 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Ferritin | EoT Ferritin | 359.3 micrograms per liter | Standard Deviation 278.61 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Ferritin | Ferritin Change from Baseline to EoT | -122.7 micrograms per liter | Standard Deviation 269.7 |
Secondary
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | Baseline Transferrin | 1.885 grams per liter | Standard Deviation 0.3049 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | EoT Transferrin | 1.902 grams per liter | Standard Deviation 0.3267 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | Transferrin Change from Baseline to EoT | 0.019 grams per liter | Standard Deviation 0.1839 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | Baseline Transferrin | 1.921 grams per liter | Standard Deviation 0.3224 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | EoT Transferrin | 1.987 grams per liter | Standard Deviation 0.3366 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin | Transferrin Change from Baseline to EoT | 0.066 grams per liter | Standard Deviation 0.2138 |
Secondary
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT)
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | Baseline TSAT | 27.9 percentage | Standard Deviation 8.25 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | EoT TSAT | 27.1 percentage | Standard Deviation 8.01 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | TSAT Change from Baseline to EoT | -0.9 percentage | Standard Deviation 7.65 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | Baseline TSAT | 28.2 percentage | Standard Deviation 8.58 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | EoT TSAT | 24.6 percentage | Standard Deviation 8.42 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) | TSAT Change from Baseline to EoT | -3.7 percentage | Standard Deviation 7.33 |
Secondary
Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC)
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) will be quantified.
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT UIBC | 31.03 micromoles per liter | Standard Deviation 6.501 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Serum Iron Change from Baseline to EoT | -0.244 micromoles per liter | Standard Deviation 3.4146 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline Serum Iron | 11.663 micromoles per liter | Standard Deviation 3.7879 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline TIBC | 41.83 micromoles per liter | Standard Deviation 6.184 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | UIBC Change from Baseline to EoT | 0.92 micromoles per liter | Standard Deviation 4.359 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT TIBC | 42.47 micromoles per liter | Standard Deviation 6.866 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT Serum Iron | 11.438 micromoles per liter | Standard Deviation 3.5804 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | TIBC Change from Baseline to EoT | 0.67 micromoles per liter | Standard Deviation 0.093 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline UIBC | 30.17 micromoles per liter | Standard Deviation 5.866 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | TIBC Change from Baseline to EoT | 1.22 micromoles per liter | Standard Deviation 4.466 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline UIBC | 30.70 micromoles per liter | Standard Deviation 6.481 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT UIBC | 33.24 micromoles per liter | Standard Deviation 7.115 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | UIBC Change from Baseline to EoT | 2.56 micromoles per liter | Standard Deviation 4.653 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline Serum Iron | 11.949 micromoles per liter | Standard Deviation 3.9547 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT Serum Iron | 10.658 micromoles per liter | Standard Deviation 3.3615 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Serum Iron Change from Baseline to EoT | -1.342 micromoles per liter | Standard Deviation 3.3957 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | Baseline TIBC | 42.65 micromoles per liter | Standard Deviation 6.942 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Pre-Dialysis Serum Iron, and Pre-Dialysis Total Iron-Binding Capacity (TIBC) | EoT TIBC | 43.90 micromoles per liter | Standard Deviation 6.928 |
Secondary
Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
The Mean Change from Stage 2 Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr)
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | Baseline CHr | 32.57 picograms | Standard Deviation 2.239 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | EoT CHr | 32.01 picograms | Standard Deviation 2.14 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | CHr Change from Baseline to EoT | -0.56 picograms | Standard Deviation 0.021 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | Baseline CHr | 32.54 picograms | Standard Deviation 1.928 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | EoT CHr | 31.69 picograms | Standard Deviation 2.13 |
| Stage 2 Placebo (Standard Dialysate) | Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin (CHr) | CHr Change from Baseline to EoT | -0.86 picograms | Standard Deviation 1.48 |
Secondary
Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis
The mean difference between the pre-dialysis and post-dialysis serum iron was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time frame: Up to 48 weeks from date of randomization
Population: modified intent-to-treat: all randomized subjects who received at least one dose of study drug and had at least one post-dialysis hemoglobin measured.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | mean pre-dialysis serum iron | 11.634 micromoles per liter | Standard Deviation 3.2506 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | mean post-dialysis serum iron | 31.347 micromoles per liter | Standard Deviation 7.9885 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | serum iron change from pre- to post-dialysis | 19.675 micromoles per liter | Standard Deviation 6.8227 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | mean pre-dialysis serum iron | 11.086 micromoles per liter | Standard Deviation 3.0143 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | mean post-dialysis serum iron | 12.247 micromoles per liter | Standard Deviation 4.072 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Serum Iron From Pre-Dialysis to Post-Dialysis | serum iron change from pre- to post-dialysis | 1.194 micromoles per liter | Standard Deviation 3.4709 |
Secondary
Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis
The mean difference between the pre-dialysis and post-dialysis TSAT (transferrin) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | mean pre-dialysis TSAT (transferrin) | 24.7 percent | Standard Deviation 6.67 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | mean post-dialysis TSAT (transferrin) | 62.3 percent | Standard Deviation 13.32 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | pre- to post-dialysis change in TSAT | 37.5 percent | Standard Deviation 11.46 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | mean pre-dialysis TSAT (transferrin) | 23.2 percent | Standard Deviation 8.35 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | mean post-dialysis TSAT (transferrin) | 23.3 percent | Standard Deviation 7.8 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Transferrin Saturation From Pre-Dialysis to Post-Dialysis | pre- to post-dialysis change in TSAT | 0.1 percent | Standard Deviation 6.87 |
Secondary
Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis
The mean difference between the pre-dialysis and post-dialysis unsaturated iron binding capacity (UIBC) was calculated, using all post-baseline values obtained during Stage 2. Subjects could participate in Stage 2 for up to 48 weeks, provided that they did not complete Stage 2 early due to a protocol-mandated change in anemia management or withdraw from the study entirely for other reasons.
Time frame: Up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | mean pre-dialysis UIBC | 30.54 micromole per liter | Standard Deviation 5.645 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | mean post-dialysis UIBC | 17.15 micromole per liter | Standard Deviation 6.03 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | pre- to post-dialysis change in UIBC | -13.31 micromole per liter | Standard Deviation 5.024 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | mean pre-dialysis UIBC | 32.19 micromole per liter | Standard Deviation 6.847 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | mean post-dialysis UIBC | 34.75 micromole per liter | Standard Deviation 7.437 |
| Stage 2 Placebo (Standard Dialysate) | Mean Change in Unsaturated Iron-Binding Capacity (UIBC) From Pre-Dialysis to Post-Dialysis | pre- to post-dialysis change in UIBC | 2.57 micromole per liter | Standard Deviation 3.345 |
Secondary
Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel
A comparison of the lab values at the end-of-treatment (EoT) to baseline was performed, and the percentage of change from baseline was calculated for the following lab parameters: reticulocyte hemoglobin content (CHr), Ferritin, pre-dialysis unbound iron-binding capacity (UIBC), pre-dialysis serum iron, pre-dialysis transferrin, pre-dialysis total iron-binding capacity TIBC), and transferrin saturation (TSAT).
Time frame: up to 48 weeks from date of randomization
Population: 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 | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | UIBC percentage of change from baseline | 3.77 percentage of change from baseline | Standard Deviation 14.717 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Transferrin percentage of change from baseline | 1.318 percentage of change from baseline | Standard Deviation 9.3574 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Ferritin percentage of change from baseline | -11.6 percentage of change from baseline | Standard Deviation 29.51 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | TIBC percentage of change from baseline | 1.87 percentage of change from baseline | Standard Deviation 9.472 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Serum Iron percentage of change from baseline | 2.470 percentage of change from baseline | Standard Deviation 31.3742 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | TSAT percentage of change from baseline | 0.6 percentage of change from baseline | Standard Deviation 29.69 |
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | CHr percentage of change from baseline | -1.62 percentage of change from baseline | Standard Deviation 4.402 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | TSAT percentage of change from baseline | -10.5 percentage of change from baseline | Standard Deviation 25.06 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | CHr percentage of change from baseline | -2.59 percentage of change from baseline | Standard Deviation 4.49 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Ferritin percentage of change from baseline | -21.7 percentage of change from baseline | Standard Deviation 68.5 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | UIBC percentage of change from baseline | 9.46 percentage of change from baseline | Standard Deviation 16.537 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Serum Iron percentage of change from baseline | -7.313 percentage of change from baseline | Standard Deviation 27.8687 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | Transferrin percentage of change from baseline | 3.988 percentage of change from baseline | Standard Deviation 10.694 |
| Stage 2 Placebo (Standard Dialysate) | Percentage of Change From Baseline to End-of-Treatment for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and the Pre-Dialysis Serum Iron Panel | TIBC percentage of change from baseline | 3.48 percentage of change from baseline | Standard Deviation 10.166 |
Secondary
Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion
The number of patients requiring red blood cell or whole blood transfusion while in the randomized treatment stage (Stage 2). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Time frame: Up to 48 weeks from date of randomization
Population: intent-to-treat: all randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion | 6 participants |
| Stage 2 Placebo (Standard Dialysate) | Red Blood Cell or Whole Blood Transfusion: Number of Patients Who Received a Transfusion | 12 participants |
Secondary
Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused
The total number of units of red blood cells or whole blood that were received by patients while in the randomized treatment stage (Stage 2). This number is the total number of units received across all randomized patients in each treatment group (it is not the average number of units received per patient). Patients remained in Stage 2 until they met protocol-defined criteria for Stage 2 completion or until they had participated in Stage 2 for 48 weeks (whichever came sooner). If a patient was transfused, they were withdrawn from Stage 2.
Time frame: Up to 48 weeks from date of randomization
Population: intent-to-treat: all randomized subjects
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused | 15 units of red blood cells or whole blood |
| Stage 2 Placebo (Standard Dialysate) | Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused | 29 units of red blood cells or whole blood |
Secondary
Variability of Hemoglobin Concentration: Residual Standard Deviation
The mean residual standard deviation of the hemoglobin concentration changes, as measured weekly from baseline until the end of participation in Stage 2.
Time frame: up to 48 weeks from date of randomization
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Variability of Hemoglobin Concentration: Residual Standard Deviation | 4.352 grams per liter | Standard Deviation 1.501 |
| Stage 2 Placebo (Standard Dialysate) | Variability of Hemoglobin Concentration: Residual Standard Deviation | 4.407 grams per liter | Standard Deviation 2.031 |
Secondary
Variability of Hemoglobin Concentration: Temporal Trend
The mean temporal trend of hemoglobin concentration value changes, as measured weekly from baseline until the end of participation in Stage 2.
Time frame: up to 48 weeks from date of randomization
Population: 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 | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stage 2 Soluble Ferric Pyrophosphate (SFP) in Dialysate | Variability of Hemoglobin Concentration: Temporal Trend | 0.023 grams per liter per week | Standard Deviation 0.222 |
| Stage 2 Placebo (Standard Dialysate) | Variability of Hemoglobin Concentration: Temporal Trend | 0.003 grams per liter per week | Standard Deviation 0.35 |