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

This study has been completed.
Sponsor:
Collaborator:
Collaborative Study Group (CSG)
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00648167
First received: March 27, 2008
Last updated: October 10, 2014
Last verified: October 2014

March 27, 2008
October 10, 2014
March 2008
January 2009   (final data collection date for primary outcome measure)
The Difference in Serum Phosphorus Between Baseline (Day 0) and End of Treatment (Day 28) [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
This study is exploratory in nature and is intended to assess the tolerability and safety of Zerenex. [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00648167 on ClinicalTrials.gov Archive Site
Not Provided
Serum phosphorus levels will be monitored prior to study drug titration. [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hyperphosphatemia
  • End-stage Renal Disease
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
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.
Intervention: Drug: ferric citrate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
55
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00648167
KRX-0502-201
Yes
Keryx Biopharmaceuticals
Keryx Biopharmaceuticals
Collaborative Study Group (CSG)
Study Chair: Julia B Lewis, MD Collaborative Study Group at the Nephrology Clinical Trials Center, Vanderbilt University Medical Center
Keryx Biopharmaceuticals
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP