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: September 7, 2012

Last verified: September 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	March 27, 2008
Last Updated Date	September 7, 2012
Start Date ^ICMJE	March 2008
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 5, 2009)	This study is exploratory in nature and is intended to assess the tolerability and safety of Zerenex. [ Time Frame: 4-10 months ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE (submitted: March 31, 2008)	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 ]
Change History	Complete list of historical versions of study NCT00648167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: January 5, 2009)	Serum phosphorus levels will be monitored prior to study drug titration. [ Time Frame: 4-10 months ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 31, 2008)	Serum phosphorus levels will be monitored prior to study drug titration. [ Time Frame: 4-5 months ] [ Designated as safety issue: Yes ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Official Title ^ICMJE	A Safety and Tolerability Study of Zerenex (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Hyperphosphatemia End-stage Renal Disease
Intervention ^ICMJE	Drug: ferric citrate Zerenex 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.
Study Arm (s)	Experimental: I 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
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	55
Completion Date	January 2009
Primary Completion Date	January 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 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
Gender	Both
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00648167
Other Study ID Numbers ^ICMJE	KRX-0502-201
Has Data Monitoring Committee	Yes
Responsible Party	Keryx Biopharmaceuticals
Study Sponsor ^ICMJE	Keryx Biopharmaceuticals
Collaborators ^ICMJE	Collaborative Study Group (CSG)
Investigators ^ICMJE	Not Provided
Information Provided By	Keryx Biopharmaceuticals
Verification Date	September 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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