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

NCT00967993 | Completed Results

• 1 other identifier: KRX-0502-202
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 3

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).

Conditions

Hyperphosphatemia; End-stage Renal Disease; Renal Failure Chronic Requiring Hemodialysis

Keywords

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

Outcome Measures

Primary Outcomes (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.

  4 weeks

Secondary Outcomes (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.

  6 weeks

Study Arms (1)

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

Interventions

ferric citrate DRUG

KRX-0502 will be supplied as one caplet of ferric citrate containing 210 mg of ferric iron as ferric citrate

Also known as: KRX-0502

KRX-0502 (ferric citrate)

Eligibility Criteria

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

Study Population

Patients selected from pool of dialysis patients at each clinic.

You may qualify if:

• Males and non-pregnant, non-lactating females
• Age \> 18 years
• On thrice weekly hemodialysis for at least the previous three months prior to screening
• Serum phosphorus levels ≥ 2.5 mg/dL and \< 8.5 mg/dL at Screening Visit (Visit 0)
• Serum phosphorus levels \> 5.5 mg/dL at Study Drug Initiation Visit (Visit 3)
• 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
• Serum ferritin \<1000micrograms/L and Transferrin Saturation (TSAT) \<50%
• Willing to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)
• Willing and able to give informed consent

You may not qualify if:

• Parathyroidectomy within six months prior to Screening Visit (Visit 0)
• Actively symptomatic gastrointestinal bleeding and inflammatory bowel disease
• 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)
• History of multiple drug allergies
• History of malignancy in the last five years (treated cervical or skin cancer may be permitted if approved by Keryx)
• Previous intolerance to oral ferric citrate
• Absolute requirement for oral iron therapy
• Absolute requirement for Vitamin C (multivitamins \[Centrum, Nephrocaps, Renaphro, etc.\] 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

Sponsors & Collaborators

• Keryx Biopharmaceuticals: lead

Study Sites (3)

Barzilai Medical Center Ben-Gurion University

Ashkelon, 78306, Israel

Location

Hadassah University Hospital-Ein Kerem

Jerusalem, 91120, Israel

Location

Assaf Haraofeh Medical Center

Ẕerifin, 70300, Israel

Location

Related Publications (2)

• Hsu CH, Patel SR, Young EW. New phosphate binding agents: ferric compounds. J Am Soc Nephrol. 1999 Jun;10(6):1274-80. doi: 10.1681/ASN.V1061274.

  PMID: 10361865 BACKGROUND

• 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. doi: 10.1093/ndt/17.2.265.

  PMID: 11812877 BACKGROUND

Related Links

• Sponsor Website

MeSH Terms

Conditions

Hyperphosphatemia; Kidney Failure, Chronic; Diabetes Mellitus

Interventions

ferric citrate

Condition Hierarchy (Ancestors)

Phosphorus Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; 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; Glucose Metabolism Disorders; Endocrine System Diseases

Results Point of Contact

• Title: Medical Information
• Organization: Keryx Biopharmaceuticals Inc

medicalinfo@keryx.com

1-844-44-KERYX (1-844-445-379

Study Officials

• Itamar Raz, MD

  Hadassah University Hospital-Ein Kerem

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2009
• First Posted: August 28, 2009
• Study Start: January 1, 2010
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: December 5, 2014
• Results First Posted: November 18, 2014

Record last verified: 2014-11

Locations

IL (3)