Phase 2
N=55
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Hyperphosphatemia · End-stage Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00648167 ↗Enrolled (actual)
55
Serious AEs
7.3%
Results posted
Oct 2014
Primary outcome: Primary: The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) — 5.9; 5.4 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- ferric citrate (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Keryx Biopharmaceuticals
- Primary completion
- Jan 2009
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 | — |
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.
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
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.