Status:
COMPLETED
Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
Lead Sponsor:
Rockwell Medical Technologies, Inc.
Conditions:
End Stage Renal Disease
Chronic Kidney Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the parent study is to assess the short-term safety and tolerability of soluble ferric pyrophosphate (SFP) in dialysate administered to a large number of representative adult chronic ki...
Detailed Description
Parent Study: randomized, double-blinded, crossover, up to 6 weeks, 700 patients. Patients were randomized to receive SFP 2 µmoles (110 µg) iron/L of dialysate in liquid bicarbonate concentrate or pla...
Eligibility Criteria
Inclusion
- Parent Study, Double Blinded, Crossover:
- Key
- Adult ≥ 18 years of age.
- Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD subjects) and regularly undergoing 2 or more dialysis sessions per week.
- Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.
- Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.
- Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).
- Key
Exclusion
- Any previous exposure to SFP.
- Therapy with intravenous, intramuscular or oral iron at any time between the first/screening visit and the randomization visit, or anticipated requirement for iron supplementation during the study period.
- Non-tunneled vascular catheter for dialysis.
- Scheduled for kidney transplant within the next 8 weeks.
- Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to screening, or during screening period prior to randomization.
- Hospitalization within 1 month prior to screening (except for vascular access surgery).
- Extension Study, Open Label, Single Active Arm:
- Key Inclusion Criteria:
- Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.
- Hemoglobin ≤12.0 g/dL at screening.
- TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
- Serum ferritin ≤1000 µg/L at screening. (Excursion of ferritin by ≤10% outside this range permitted only if all other inclusion/exclusion criteria are met).
- Key
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
718 Patients enrolled
Trial Details
Trial ID
NCT01503021
Start Date
November 1 2011
End Date
January 1 2014
Last Update
October 25 2016
Active Locations (31)
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1
Mobile, Alabama, United States, 36688
2
Northridge, California, United States, 91324
3
Arvada, Colorado, United States, 80002
4
Westminster, Colorado, United States, 80031