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

End-stage Renal Disease Clinical Trial

Official title:

A 6-Week Feasibility Trial of a New Formulation of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00967993
• Other study ID #: KRX-0502-202
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2009
• Last updated: November 19, 2014
• Start date: January 2010
• Est. completion date: May 2010

Study information

• Verified date: November 2014
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• End-stage Renal Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Failure Chronic Requiring Hemodialysis

Intervention

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

Locations

Country	Name	City	State
Israel	Barzilai Medical Center Ben-Gurion University	Ashkelon
Israel	Hadassah University Hospital-Ein Kerem	Jerusalem
Israel	Assaf Haraofeh Medical Center	Zerifin

Sponsors (1)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes

External Links

•   Sponsor Website