Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

Study Description

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Brief Summary:

The objective of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a dietary phosphate binder in controlling and managing serum phosphorus levels in patients with end-stage renal disease (ESRD).

Condition or disease	Intervention/treatment
Hyperphosphatemia; End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis	Drug: ferric citrate

Detailed Description:

This is a multi-center, non-blinded, efficacy and tolerability trial in patients with ESRD on dialysis three times per week. Approximately 24 patients (approximately twelve diabetic patients and approximately twelve non-diabetic patients) in Israel will be initiated on KRX-0502 (ferric citrate). The study will consist of a two-week washout period immediately followed by a six-week treatment period in. Patients will be initiated on study drug over two to three weeks.

Study Design

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Study Type :	Observational
Actual Enrollment :	22 participants
Time Perspective:	Retrospective
Official Title:	A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)
Study Start Date :	January 2010
Actual Primary Completion Date :	May 2010
Actual Study Completion Date :	May 2010

Groups and Cohorts

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Group/Cohort

Intervention/treatment

KRX-0502 (ferric citrate); KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate. All patients initiated on study drug will start with a fixed dose of KRX-0502 (ferric citrate) of 6 caplets per day. Patients will be titrated at Visits 4, 5, and 6 based on serum phosphorus lab results. If serum phosphorus levels go below normal, there will be a decrease in pills; if serum phosphorus levels go above normal, there wil be an increase in pills. The maximum number of KRX-0502 (ferric citrate) caplets per day will be 12, or 12 g/day of ferric citrate. Patients will take study drug orally with meals or snacks or within one hour after their meals or snacks.

Drug: ferric citrate; KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate; Other Name: KRX-0502

Outcome Measures

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Primary Outcome Measures :

1. The Primary Outcome of This Trial Will be the Change in Serum Phosphorus From Baseline to End of Treatment After a Four Week Treatment Period. [ Time Frame: 4 weeks ]

Secondary Outcome Measures :

1. The Incidence of Treatment-emergent Adverse Events (New or Worsened From Study Drug Initiation) Will be Summarized by Body System, Severity, Type of Adverse Event, and Presumed Relationship to the Study Drug. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Patients selected from pool of dialysis patients at each clinic.

Criteria

Inclusion Criteria:

1. Males and non-pregnant, non-lactating females
2. Age > 18 years
3. On thrice weekly hemodialysis for at least the previous three months prior to screening
4. Serum phosphorus levels ≥ 2.5 mg/dL and < 8.5 mg/dL at Screening Visit (Visit 0)
5. Serum phosphorus levels > 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
6. Taking 3 to 18 tablets/capsules/day of calcium acetate calcium carbonate, lanthanum carbonate, sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at screening
7. Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50%
8. Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
9. Willing and able to give informed consent

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening Visit (Visit 0)
2. Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
3. Serum phosphorus levels >10.0 mg/dL documented in the three monthly laboratories (done routinely in the dialysis unit) in the three months prior to the Screening Visit (Visit 0)
4. History of multiple drug allergies
5. History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
6. Previous intolerance to oral ferric citrate
7. Absolute requirement for oral iron therapy
8. Absolute requirement for Vitamin C (multivitamins [Centrum, Nephrocaps, Renaphro, etc.] allowed)
9. Absolute requirement for calcium, magnesium, or aluminum containing drugs with meals
10. Psychiatric disorder that interferes with the patient's ability to comply with the study protocol
11. Inability to tolerate oral drug intake
12. Planned surgery or hospitalization during the study (scheduled outpatient access surgery allowed)
13. 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
14. Receipt of any investigational drug within 30 days of randomization
15. Inability to cooperate with study personnel or history of noncompliance
16. Prior exposure to ferric citrate
17. Patients with hemochromatosis or Thalassemia

Contacts and Locations

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Locations

Israel
Barzilai Medical Center Ben-Gurion University
Ashkelon, Israel, 78306
Hadassah University Hospital-Ein Kerem
Jerusalem, Israel, 91120
Assaf Haraofeh Medical Center
Zerifin, Israel, 70300

Sponsors and Collaborators

Keryx Biopharmaceuticals

Investigators

Principal Investigator:	Itamar Raz, MD	Hadassah University Hospital-Ein Kerem

More Information

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Additional Information:

Sponsor Website 

Publications:

Hsu CH, Patel SR, Young EW. New phosphate binding agents: ferric compounds. J Am Soc Nephrol. 1999 Jun;10(6):1274-80.

Yang WC, Yang CS, Hou CC, Wu TH, Young EW, Hsu CH. An open-label, crossover study of a new phosphate-binding agent in haemodialysis patients: ferric citrate. Nephrol Dial Transplant. 2002 Feb;17(2):265-70.

Responsible Party:	Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00967993 History of Changes
Other Study ID Numbers:	KRX-0502-202
First Posted:	August 28, 2009
Results First Posted:	November 18, 2014
Last Update Posted:	December 5, 2014
Last Verified:	November 2014

Keywords provided by Keryx Biopharmaceuticals:

hyperphosphatemia; end-stage renal disease; ESRD	hemodialysis; diabetes; dialysis

Additional relevant MeSH terms:

Kidney Diseases; Kidney Failure, Chronic; Renal Insufficiency; Hyperphosphatemia; Urologic Diseases; Renal Insufficiency, Chronic; Phosphorus Metabolism Disorders; Metabolic Diseases	Citric Acid; Ferric Compounds; Anticoagulants; Calcium Chelating Agents; Chelating Agents; Sequestering Agents; Molecular Mechanisms of Pharmacological Action; Hematinics