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

NCT00648167 | Completed Phase 2 Results DMC

• 1 other identifier: KRX-0502-201
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperphosphatemia; End-stage Renal Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28)

  28 days

Study Arms (1)

KRX-0502 (ferric citrate)

EXPERIMENTAL

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

Interventions

ferric citrate 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.

Also known as: KRX-0502

KRX-0502 (ferric citrate)

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Keryx Biopharmaceuticals: lead
• Collaborative Study Group (CSG): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Links

• Sponsor

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic; Renal Insufficiency

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Medical Information
• Organization: Keryx Biopharmaceuticals Inc

medicalinfo@keryx.com

1-844-44-KERYX (1-844-445-3799

Study Officials

• Julia B Lewis, MD

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

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: April 4, 2017
• Results First Posted: October 9, 2014

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)