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

Hyperphosphatemia Clinical Trial

Official title:

A Three-Period, 58-Week Safety and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01510106
• Other study ID #: KRX-0502-304
• Status: Completed
• Phase: Phase 3
• First received: January 10, 2012
• Last updated: February 3, 2016
• Start date: April 2011
• Est. completion date: March 2013

Study information

• Verified date: February 2016
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4
• Est. completion date: March 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Males or non-pregnant, non-breast-feeding females

2. Age greater than or equal to 18 years

3. On thrice-weekly hemodialysis or on peritoneal dialysis for at least the previous three months prior to Screening Visit (Visit 0)

4. 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)

5. Serum phosphorus greater than or equal to 6.0 mg/dL during the Washout Period (visits 2 or 3)

6. 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)

7. Serum ferritin less than 1000 micrograms/L and TSAT less than 50% at the Screening Visit (Visit 0)

8. Willing to be discontinued from current phosphate binder(s) and initiated on ferric citrate

9. Willing and able to give informed consent

10. Life expectancy greater than 1 year -

Exclusion Criteria:

1. Parathyroidectomy within six months prior to Screening Visit (Visit 0)

2. Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease

3. 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)

4. 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

5. History of multiple drug allergies or intolerances

6. History of malignancy in the last five years (treated cervical or non-melanomatous skin cancer may be permitted if approved by CCC)

7. Previous intolerance to oral ferric citrate

8. Intolerance to oral iron-containing products

9. Absolute requirement for oral iron therapy

10. Absolute requirement for Vitamin C (multivitamins [Nephrocaps, Renaphro, etc.] allowed)

11. 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. -

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• ESRD
• Hyperphosphatemia
• Kidney Failure, Chronic

Intervention

Drug:
• Calcium acetate, sevelamer carbonate
per package insert
• Ferric citrate
6 caplets daily to start. Titrate as needed to up to 12 per day.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Keryx Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 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.	56 weeks	Yes