Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis
Condition: End Stage Renal Disease; Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
Intervention: SFP; Placebo
Intervention description: Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate; Dialysis with standard liquid bicarbonate concentrate without iron
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 718.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Soluble ferric pyrophosphate; Chronic kidney disease; Chronic hemodialysis; Ferric pyrophosphate citrate

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 kidney disease patients on hemodialysis (CKD-HD).

      The purpose of the extension study is to assess the long-term safety and tolerability of SFP.
    

Eligibility criteria:

        Parent Study, Double Blinded, Crossover:

        Key Inclusion Criteria:

          1. Adult ≥ 18 years of age.

          2. Has chronic kidney disease (CKD) receiving maintenance hemodialysis (HD) (CKD-HD
             subjects) and regularly undergoing 2 or more dialysis sessions per week.

          3. Stable pre-dialysis Hgb ≥ 9.0 to ≤ 12.5 g/dL.

          4. Stable pre-dialysis TSAT ≥ 15% to ≤ 45%.

          5. Stable pre-dialysis ferritin ≥ 100 to ≤ 1200 µg/L (1200 ng/mL).

        Key Exclusion Criteria:

          1. Any previous exposure to SFP.

          2. 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.

          3. Non-tunneled vascular catheter for dialysis.

          4. Scheduled for kidney transplant within the next 8 weeks.

          5. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks
             prior to screening, or during screening period prior to randomization.

          6. Hospitalization within 1 month prior to screening (except for vascular access
             surgery).

        Extension Study, Open Label, Single Active Arm:

        Key Inclusion Criteria:

          1. Participated in Parent Study RMTI-SFP-6 and completed the follow-up/early term visit.

          2. Hemoglobin ≤12.0 g/dL at screening.

          3. TSAT ≤45% at screening. (Excursion of TSAT by ≤10% outside this range permitted only
             if all other inclusion/exclusion criteria are met).

          4. 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 Exclusion Criteria:

          1. Had a serious adverse event attributable (i.e., probably, possibly, or definitely
             related) to study drug or had an adverse event attributable to study drug that
             necessitated premature withdrawal from the double-blind, placebo-controlled crossover
             phase of the parent study RMTI-SFP-6.

          2. Non-tunneled vascular catheter for dialysis.

          3. Scheduled for kidney transplant within 12 weeks after entry into extension phase.

          4. Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks
             prior to dosing.

          5. Pregnancy or intention to become pregnant during the study.