Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis

This study has been completed.

Sponsor:

Collaborator:

Keryx Biopharmaceuticals

Information provided by (Responsible Party):

University of Pennsylvania

ClinicalTrials.gov Identifier:

NCT01510106

First received: January 10, 2012

Last updated: March 14, 2013

Last verified: January 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 10, 2012
Last Updated Date	March 14, 2013
Start Date ^ICMJE	April 2011
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 12, 2012)	The primary efficacy outcome of this trial will be the effect of ferric citrate vs. placebo on the change in serum phosphorus from study-baseline (Visit 21, Week 52) to end of the Efficacy Assessment Period (Visit 25, Week 56). [ Time Frame: 56 weeks ] [ Designated as safety issue: Yes ] The primary efficacy outcome of this trial will be the effect of ferric citrate vs. placebo on the change in serum phosphorus from study-baseline (Visit 21, Week 52) to end of the Efficacy Assessment Period (Visit 25, Week 56). The primary efficacy variable will be analyzed via an ANCOVA model with treatment as the fixed effect and study-baseline as the covariate. Between-treatment differences will be estimated and two-sided 95% confidence intervals for the differences will be presented.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01510106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Ferric Citrate in Patients With End-Stage Renal Disease on Dialysis
Official Title ^ICMJE	A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis
Brief Summary	The main purpose of this study is to determine the long-term safety over 52 weeks of up to twelve (12) caplets/day of KRX-0502 (ferric citrate) in patients with end-stage renal disease undergoing either hemodialysis or peritoneal dialysis and to determine the efficacy of KRX-0502 (ferric citrate) in a four-week, randomized, open-label, placebo-controlled Efficacy Assessment Period. Main eligibility criteria Males or non-pregnant, non-breast-feeding females, age 18 years, on thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0), Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0), Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (Visits 2 or 3), taking 3 to 18 pills/day of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination and serum ferritin less than 1000 micrograms/L and less than TSAT 50% at the Screening Visit (Visit 0).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	ESRD Dialysis Hyperphosphatemia
Intervention ^ICMJE	Drug: Calcium acetate, sevelamer carbonate per package insert Drug: Ferric citrate 6 caplets daily to start. Titrate as needed to up to 12 per day.
Study Arm (s)	Active Comparator: Active Control Patients will return to their previously prescribed medication regimen Intervention: Drug: Calcium acetate, sevelamer carbonate Experimental: Ferric Citrat Patients will be prescribed 6 pills daily 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	4
Completion Date	March 2013
Primary Completion Date	November 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Males or non-pregnant, non-breast-feeding females Age greater than or equal to 18 years On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0) Serum phosphorus levels greater than or equal to 2.5 mg/dL and less than or equal to 8.0 mg/dL at Screening Visit (Visit 0) Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (visits 2 or 3) Taking 3 to 18 pills per day (or 2-10 gm) of calcium acetate, calcium carbonate, lanthanum carbonate, and/or sevelamer (carbonate or hydrochloride or equivalent sevelamer powder) or any other agent serving as a phosphate binder, or any combination of these agents as reported by the patient at Screening Visit (Visit 0) Serum ferritin less than 1000 micrograms/L and TSAT less than 50% at the Screening Visit (Visit 0) Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate Willing and able to give informed consent Life expectancy greater than 1 year - Exclusion Criteria: Parathyroidectomy within six months prior to Screening Visit (Visit 0) Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease Serum phosphorus levels greater than or equal to 10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in all of the 3 months prior to the Screening Visit (Visit 0) Patients with baseline ferritin levels of greater than or equal to 1000 ng/mL and TSAT greater than or equal to 50% documented in the three monthly labs prior to the screening visit History of multiple drug allergies or intolerances History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC) Previous intolerance to oral ferric citrate Intolerance to oral iron-containing products Absolute requirement for oral iron therapy Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed) Absolute requirement for calcium-, magnesium-, or aluminum-containing drugs with meals 12 Psychiatric disorder that interferes with the patients ability to comply with the study protocol 13. Inability to tolerate oral drug intake 14. Intolerance to calcium acetate and sevelamer carbonate 15. Planned surgery or hospitalization during the trial (for example scheduled outpatient access surgery, eye laser surgery, etc allowed-Please contact CCC with any question) 16. Any other medical condition that renders the patient unable to or unlikely to complete the trial or that would interfere with optimal participation in the trial or produce significant risk to the patient 17. Receipt of any investigational drug within 30 days of Screening Visit (Visit 0) 18. Inability to cooperate with study personnel or history of noncompliance 19. Unsuitable for this trial per Investigators clinical judgment. -
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01510106
Other Study ID Numbers ^ICMJE	KRX-0502-304
Has Data Monitoring Committee	Yes
Responsible Party	University of Pennsylvania
Study Sponsor ^ICMJE	University of Pennsylvania
Collaborators ^ICMJE	Keryx Biopharmaceuticals
Investigators ^ICMJE	Not Provided
Information Provided By	University of Pennsylvania
Verification Date	January 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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