Phase 2 Completed N=55 Treatment

A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Hyperphosphatemia · End Stage Renal Disease

Source: ClinicalTrials.gov NCT00648167 ↗

Enrolled (actual)

Serious AEs

7.3%

Results posted

Oct 2014

Primary outcomePrimary: The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) — 5.9; 5.4 mg/dL

Summary

This study is to evaluates the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)	5.9; 5.4	—

Eligibility Criteria

Inclusion Criteria

Males and non-pregnant, nonlactating females
Age > 18 years
On thrice weekly hemodialysis for at least the previous 3 months prior to randomization
Phosphorous levels ≥3.5mg/dL at Screening Visit
On at least 12 tablets/capsules/day of calcium acetate (667mg), calcium carbonate (500mg), lanthanum carbonate (500mg), sevelamer hydrochloride (800mg or two 400mg tablets), or any combination of these agents
Serum ferritin 10.0 mg/dL documented in the 3 monthly laboratories (done routinely in the dialysis unit) in the 3 months prior to the Screening Visit
History of multiple drug allergies
History of malignancy in the last 5 years (treated cervical or skin cancer may be permitted if approved by CCC)
Previous intolerance to oral ferric citrate
Absolute requirement for oral iron therapy
Absolute requirement for Vitamin C (multivitamins [Neprocaps, Renaphro, etc.] allowed)
Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
Inability to tolerate oral drug intake
Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
Any other medical condition that renders the patient unable to or unlikely to complete the study or that would interfere with optimal participation in the study or produce significant risk to the patient
Receipt of any investigational drug within 30 days of randomization
Inability to cooperate with study personnel or history of noncompliance

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00648167). 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.