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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00967993
First received: August 27, 2009
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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 Intervention Phase
Hyperphosphatemia
End-stage Renal Disease
Hemodialysis
di
Dialysis
Drug: ferric citrate
Phase 2

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Keryx Biopharmaceuticals:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 20
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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 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 Talassemia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00967993

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

Additional Information:
Publications:
Responsible Party: Keryx Biopharmaceuticals
ClinicalTrials.gov Identifier: NCT00967993     History of Changes
Other Study ID Numbers: KRX-0502-202
Study First Received: August 27, 2009
Last Updated: September 7, 2012
Health Authority: Israel: Ministry of Health

Keywords provided by Keryx Biopharmaceuticals:
hyperphosphatemia
end-stage renal disease
ESRD
hemodialysis
diabetes
dialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases
Citric Acid
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 28, 2014