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

NCT ID: NCT00648167

Last Updated: 2017-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-03-31
• Study Completion Date: 2009-01-31

Brief 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.

Detailed Description

The purpose of this study is to evaluate the safety and tolerability of Zerenex™ (ferric citrate) as a treatment for hyperphosphatemia in patients with End-Stage Renal Disease. These patients will be switched to Zerenex™ from their current high dose of phosphate binder and, based on their serum phosphorus levels, will be titrated up from 3.4g/day of Zerenex™ to maximum tolerated and safe doses of Zerenex™. Doses will be adjusted weekly, based on serum phosphorus levels, with the maximum dose administered being approximately 12g/day.

Conditions

Hyperphosphatemia; End-stage Renal Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

KRX-0502 (ferric citrate)

All patients will be switched from their current phosphate binder to Zerenex, and titrated to the maximum tolerated dose (up to about 12g/day) based on their serum phosphorus levels.

Group Type: EXPERIMENTAL

ferric citrate

Intervention Type: DRUG

ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.

Interventions

ferric citrate

ferric citrate will be provided as a 375mg capsule. Dosing and frequency are dependent on patient's serum phosphorus levels. Dosing will occur over the 28-day study.

Intervention Type: DRUG

Other Intervention Names

KRX-0502

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 <1000micrograms/L and Transferrin Saturation (TSAT) <50%
• Willing to be discontinued from current phosphate binder(s) and initiated on Zerenex
• Willing and able to give informed consent

Exclusion Criteria

• Parathyroidectomy within 6 months prior to Screening
• Actively symptomatic GI disease such as peptic ulcer disease, gastro esophageal reflux, diverticulosis, irritable bowel syndrome (treated asymptomatic is permitted)
• History of documented inflammatory bowel disease or erosive esophagitis
• Serum Phosphorus levels >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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Collaborative Study Group (CSG)

NETWORK

Sponsor Role: collaborator

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Julia B Lewis, MD

Role: STUDY_CHAIR

Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

Related Links

http://www.keryx.com

Sponsor

Other Identifiers

KRX-0502-201

Identifier Type: -

Identifier Source: org_study_id