Phase 3
N=305
Continuous Soluble Ferric Pyrophosphate (SFP) Iron Delivery Via Dialysate in Hemodialysis Patients
Renal Failure Chronic Requiring Hemodialysis
Bottom Line
View on ClinicalTrials.gov: NCT01320202 ↗Enrolled (actual)
305
Serious AEs
32.1%
Results posted
Apr 2015
Primary outcome: Primary: Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean — 0.6; -3.0 grams per liter — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Soluble Ferric Pyrophosphate (SFP) (Drug); Standard dialysate (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Rockwell Medical Technologies, Inc.
- Primary completion
- May 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline Hemoglobin at End-of-Treatment: Least-Squares Mean |
0.6; -3.0 | 0.011 sig |
| PRIMARY Change From Baseline Hemoglobin at End-of-Treatment: Mean Baseline and End-of-Treatment Hgb |
109.6; 109.0; 109.1; 105.2; -0.4; -3.9 | — |
| SECONDARY Mean Change in Serum Iron From Pre-dialysis to Post-dialysis. |
12.1; 10.8; 29.6; 11.5; 17.5; 0.6 | — |
| SECONDARY Mean Change in TSAT (Transferrin) From Pre-dialysis to Post-dialysis. |
24.9; 22.4; 57.9; 22.2; 32.7; -0.4 | — |
| SECONDARY Mean Change in Unsaturated Iron Binding Capacity (UIBC) From Pre- to Post-dialysis. |
31.49; 32.27; 19.48; 34.51; -11.86; 2.38 | — |
| SECONDARY Red Blood Cell or Whole Blood Transfusion: Number of Patients Receiving Transfusion |
3; 11 | — |
| SECONDARY Red Blood Cell or Whole Blood Transfusion: Number of Units Transfused |
5; 19 | — |
| SECONDARY Percentage of Change From Baseline to End-of-Treatment (EoT) for: Reticulocyte Hemoglobin Content (CHr), Ferritin, and Pre-Dialysis Serum Iron Panel |
-0.64; -2.73; -14.8; -28.5; 8.36; 7.62 | — |
| SECONDARY Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Unsaturated Iron-Binding Capacity (UIBC), Serum Iron, and Total Iron-Binding Capacity (TIBC) |
30.91; 30.77; 32.76; 33.03; 1.93; 2.14 | — |
| SECONDARY Change From Baseline to End-of-Treatment (EoT) in Reticulocyte Hemoglobin Content (CHr) |
32.37; 32.57; 32.12; 31.64; -0.23; -0.91 | — |
| SECONDARY Change From Baseline to End-of-Treatment (EoT) in Ferritin |
509.6; 511.3; 440.7; 366.9; -72.3; -143.1 | — |
| SECONDARY Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin |
1.928; 1.908; 1.958; 1.957; 0.029; 0.044 | — |
| SECONDARY Change From Baseline to End-of-Treatment (EoT) in Pre-Dialysis Transferrin Saturation (TSAT) |
28.1; 27.1; 27.3; 24.0; -1.1; -3.0 | — |
| SECONDARY Variability of Hemoglobin Concentration: Temporal Trend |
0.060; 0.002 | — |
| SECONDARY Variability of Hemoglobin Concentration: Residual Standard Deviation |
4.104; 4.588 | — |
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).
Eligibility 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 11.5 g/dL over ≥ 1 week confirmed by ≥ 2 consecutive measurements AND an associated increase in Hgb by ≥ 1 g/dL over 4 weeks.
Main Exclusion Criteria:
- Patient in Stage 2 who has been prematurely withdrawn from Stage 2 for any reason other than as noted in inclusion criteria above.
Data sourced from ClinicalTrials.gov (NCT01320202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.