A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study of the Effects of Ferric Citrate in Subjects With End Stage Renal Disease

Panion & BF Biotech

Status and phase: Completed; Phase 3

Conditions: ESRD; End Stage Renal Disease; Hyperphosphatemia

Treatments: Drug: ferric citrate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01503736

PNC00301

Details and patient eligibility

About

The purpose of the study is to determine the effect and optimum dose and evaluate the safety of ferric citrate, administered three times daily (TID) immediately after meals for a total daily dose of 4 or 6 grams for 56 days, on serum phosphate (PO4) levels in subjects with end stage renal disease (ESRD).

Enrollment: 183 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18 years and has a diagnosis of ESRD
• On a three-times per week hemodialysis regimen
• On a stable dose of a phosphate-binding agent for at least one month prior to study entry.
• If on vitamin D supplementation or calcitriol, must be on a stable dose for at least one month prior to study entry.
• Hct >= 20%
• Serum Ca level of 8 mg/dL to 10.5 mg/dL

Exclusion criteria

• Is pregnant or lactating
• Clinically significant GI disorder
• Has tertiary hyperparathyroidism or is immediately post-operative from a parathyroidectomy (within the first 3 months post-op or the plasma Ca is <7 mg/dL)
• ferritin>800 ng/mL
• Unstable medical condition unsuitable for the study in the opinion of investigator
• Has been treated with an investigational agent within 30 days of enrollment
• Has a history of documented iron allergy or hemochromatosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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183 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: ferric citrate

Drug: ferric citrate

Drug: ferric citrate

4g/day

Experimental group

Description:

Ferric Citrate for a total daily dose of 4g

Treatment:

Drug: ferric citrate

Drug: ferric citrate

Drug: ferric citrate

6g/day

Experimental group

Description:

Ferric Citrate for a total daily dose of 6g

Treatment:

Drug: ferric citrate

Drug: ferric citrate

Drug: ferric citrate