A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease

End-Stage Renal Disease Clinical Trial

Official title:

A 4-Week Dose-Ranging and Efficacy Trial of KRX-0502 (Ferric Citrate) in Patients With End-Stage Renal Disease (ESRD) Following a Two-Week Washout Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01074125
• Other study ID #: KRX-0502-305
• Status: Completed
• Phase: Phase 3
• First received: February 17, 2010
• Last updated: December 3, 2014
• Start date: May 2010
• Est. completion date: November 2010

Study information

• Verified date: December 2014
• Source: Keryx Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a research study for people with high blood phosphorus levels who are on dialysis. This medical condition can cause weakening of the bones and damage other organs. This can lead to many health problems, and sometimes death. Phosphorus is in much of the food we eat, and is helpful to us in small amounts. Patients with kidney failure have trouble getting rid of the phosphorus eaten in food. Dialysis can help remove some of the phosphorus, but often patients must take a phosphate binder like PhosLo®, Renagel®, or Renvela® to bring the blood phosphorus levels back to normal. The purpose of this study is to see if KRX-0502 (ferric citrate) is safe and effective as a phosphate binder.

Description:

There will be a screening visit about 4 weeks receiving study drug. Upon qualifying for the study after the screening visit, patients will then be asked to stop taking their current phosphate binder for about 2 weeks. Then, if patients continue to qualify for the study, they will be entered in the study that lasts about 28 days. Study visits will happen every week during the patient's usual dialysis appointments. There will be a total of up to 9 visits for this study, and total participation time could last up to 8 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 154
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Males or non-pregnant, non-lactating females

• Age > 18 years

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

• Serum phosphorus levels = 3.5 mg/dL and < 8.0 mg/dL at Screening Visit (Visit 0)

• Serum phosphorus levels > 6.0 mg/dL during the washout period (Visits 2 or 3)

• Taking 3 to 15 tablets/capsules per day of 667mg calcium acetate or 800 mg sevelamer (hydrochloride or carbonate), or any combination of these agents as reported by the patient at Screening Visit (Visit 0)

• Serum ferritin <1000micrograms/L and Transferrin Saturation (TSAT) <50% at the Screening Visit (Visit 0)

• Willingness to be discontinued from current phosphate binder(s) and initiated on KRX-0502 (ferric citrate)

• Willing and able to give informed consent

• Willing and able to stay on a constant dose of Vitamin D (or its analogs) and Sensipar (cinacalcet) for the treatment period, if applicable.

Exclusion Criteria:

• Parathyroidectomy within six months prior to Screening Visit (Visit 0)

• Actively symptomatic gastrointestinal bleeding or inflammatory bowel disease

• Serum phosphorus levels >10.0 mg/dL documented in all of 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 or intolerances

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

• Previous intolerance to oral ferric citrate

• Absolute requirement for oral iron therapy

• Absolute requirement for Vitamin C (multivitamins [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 trial (scheduled outpatient access surgery allowed)

• 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

• Receipt of any investigational drug within 30 days of Screening Visit (Visit 0)

• Inability to cooperate with study personnel or history of noncompliance

• Unsuitable for this trial per Principal Investigator's clinical judgment

Study Design

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

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Drug:
• ferric citrate
1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Locations

Country	Name	City	State
Puerto Rico	RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico	Rio Piedras
United States	Kidney Care Associates, LLC	Augusta	Georgia
United States	Brookdale Physician's Dialysis Associates	Brooklyn	New York
United States	Southeast Renal Research Institute	Chattanooga	Tennessee
United States	Circle Medical Management	Chicago	Illinois
United States	DCI	Cincinnati	Ohio
United States	Cleveland Clinical Foundation Fresenius East (Fairhill)	Cleveland	Ohio
United States	The Ohio State University Cramblett Medical Clinic	Columbus	Ohio
United States	Kidney Associates	Houston	Texas
United States	Meharry Medical College Clinical Research Center	Nashville	Tennessee
United States	Nephrology Associates, PC	Nashville	Tennessee
United States	Vanderbilt University Medical Center Clinical Trials Center	Nashville	Tennessee
United States	Pines Clinical Research, Inc.	Pembroke Pines	Florida
United States	Western New England Renal & Transplant Associates	Springfield	Massachusetts
United States	Centre Point Dialysis	West Allis	Wisconsin
United States	Western Nephrology	Westminster	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
Keryx Biopharmaceuticals	Collaborative Study Group (CSG)

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum Phosphorus From Baseline to End of Treatment	Mean change from baseline was calculated separately for each treatment arm (LOCF)	Baseline and day 28	Yes
Secondary	Pairwise Comparison of the Mean Change in Serum Phosphorus From Baseline to the End of Treatment	Mean change from baseline was calculated separately for each treatment arm. Only subjects that have both baseline and end of treatment serum phosphorus scores were analyzed for this outcome.	Baseline and day 28	Yes
Secondary	Proportion of Patient With a Serum Phosphorus =5.5 mg/dL at the End of Treatment	proportion was calculated separately for each treatment arm	Baseline and day 28	Yes