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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hyperphosphatemia; End-stage Renal Disease	Drug: ferric citrate	Phase 2

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.

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	55 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Study Start Date :	March 2008
Actual Primary Completion Date :	January 2009
Actual Study Completion Date :	January 2009

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: 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.	Drug: 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.; Other Name: KRX-0502

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) [ Time Frame: 28 days ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	19 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Keryx Biopharmaceuticals

Collaborative Study Group (CSG)

Investigators

Study Chair:	Julia B Lewis, MD	Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Sponsor 

Responsible Party:	Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00648167 History of Changes
Other Study ID Numbers:	KRX-0502-201
First Posted:	April 1, 2008
Results First Posted:	October 9, 2014
Last Update Posted:	April 4, 2017
Last Verified:	March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

Keywords provided by Keryx Biopharmaceuticals:

ESRD; end-stage renal disease; end stage renal disease; hemodialysis; dialysis; kidney failure	renal failure; kidney; renal; phosphate binder; phosphorus

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Hyperphosphatemia; Urologic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Phosphorus Metabolism Disorders; Metabolic Diseases	Citric Acid; Ferric Compounds; Anticoagulants; Calcium Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Hematinics