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

Purpose

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	Intervention	Phase
Hyperphosphatemia End-stage Renal Disease	Drug: ferric citrate	Phase 2


Study Type:	Interventional
Study Design:	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)

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases Kidney Failure

Drug Information available for: Sodium citrate

U.S. FDA Resources

Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:

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


Enrollment:	55
Study Start Date:	March 2008
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility


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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00648167

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

Additional Information:

Sponsor

This link exits the ClinicalTrials.gov site


Responsible Party:	Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00648167 History of Changes
Other Study ID Numbers:	KRX-0502-201
Study First Received:	March 27, 2008
Results First Received:	October 4, 2014
Last Updated:	March 3, 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 Renal Insufficiency, Chronic Hyperphosphatemia Urologic Diseases 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

ClinicalTrials.gov processed this record on September 21, 2017