Phase 3 Completed N=718 Randomized Triple-blind Treatment

Safety Study of Soluble Ferric Pyrophosphate (SFP) in Dialysate in CKD Patients Receiving Chronic Hemodialysis

End Stage Renal Disease · Chronic Kidney Disease

Source: ClinicalTrials.gov NCT01503021 ↗

Enrolled (actual)

718

Serious AEs

12.4%

Results posted

Apr 2015

Primary outcomePrimary: Incidence of Treatment-emergent Adverse Events — 31.6; 35.1; 95.1 percentage of participants

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Incidence of Treatment-emergent Adverse Events	31.6; 35.1; 95.1	—
PRIMARY Incidence of Treatment-emergent Adverse Events of Intradialytic Hypotension	4.3; 4.9; 12.6	—
PRIMARY Incidence of Related Suspected Hypersensitivity Reactions	0; 0; 0	—
SECONDARY Incidence of Composite Cardiovascular Events	1.0; 0.7; 13.6	—
SECONDARY Incidence of Hemodialysis Vascular Access Thrombotic Events	0.6; 0.6; 17.8	—
SECONDARY Incidence of Other Thrombotic Events	0; 0.1; 1.9	—
SECONDARY Incidence of Systemic/Serious Infections	0.4; 0.9; 11.3	—
SECONDARY Incidence of Serious Adverse Events	4.3; 5.1; 46.6	—

Eligibility Criteria

Parent Study, Double Blinded, Crossover:

Key Inclusion Criteria

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 Criteria

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 Exclusion Criteria

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.
Non-tunneled vascular catheter for dialysis.
Scheduled for kidney transplant within 12 weeks after entry into extension phase.
Active infection requiring systemic antimicrobial or antifungal therapy within 2 weeks prior to dosing.
Pregnancy or intention to become pregnant during the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01503021). 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. Informational only — not medical advice.