safety study of soluble ferric pyrophosphate (sfp) in dialysate in ckd patients receiving chronic hemodialysis

Conditions: End Stage Renal Disease; Chronic Kidney Disease

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.

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 placebo (standard liquid bicarbonate concentrate) x 2 weeks, then a 1 week washout, then crossed over to the alternate treatment x 2 weeks. extension study: open-label, single active arm, uncontrolled study, up to 53 weeks, 300 patients. following completion of the rmti-sfp-6 parent study, patients could enter the extension study, where they received sfp 2 µmoles (110 µg) iron/l of dialysate in liquid bicarbonate concentrate for up to 52 weeks.

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.

Keywords: soluble ferric pyrophosphate chronic kidney disease chronic hemodialysis ferric pyrophosphate citrate