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

NCT ID: NCT01074125

Last Updated: 2014-12-04

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperphosphatemia End-Stage Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1 g/day

1 g/day KRX-0502 (ferric citrate)

Group Type EXPERIMENTAL

ferric citrate

Intervention Type DRUG

1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

6 g/day

6 g/day KRX-0502 (ferric citrate)

Group Type EXPERIMENTAL

ferric citrate

Intervention Type DRUG

1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

8 g/day

8 g/day KRX-0502 (ferric citrate)

Group Type EXPERIMENTAL

ferric citrate

Intervention Type DRUG

1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Interventions

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ferric citrate

1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days

Intervention Type DRUG

Other Intervention Names

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KRX-0502

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Collaborative Study Group (CSG)

NETWORK

Sponsor Role collaborator

Keryx Biopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Julia B Lewis, MD

Role: STUDY_CHAIR

Collaborative Study Group (CSG)

Locations

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Western Nephrology

Westminster, Colorado, United States

Site Status

Pines Clinical Research, Inc.

Pembroke Pines, Florida, United States

Site Status

Kidney Care Associates, LLC

Augusta, Georgia, United States

Site Status

Circle Medical Management

Chicago, Illinois, United States

Site Status

Western New England Renal & Transplant Associates

Springfield, Massachusetts, United States

Site Status

Brookdale Physician's Dialysis Associates

Brooklyn, New York, United States

Site Status

DCI

Cincinnati, Ohio, United States

Site Status

Cleveland Clinical Foundation Fresenius East (Fairhill)

Cleveland, Ohio, United States

Site Status

The Ohio State University Cramblett Medical Clinic

Columbus, Ohio, United States

Site Status

Southeast Renal Research Institute

Chattanooga, Tennessee, United States

Site Status

Nephrology Associates, PC

Nashville, Tennessee, United States

Site Status

Meharry Medical College Clinical Research Center

Nashville, Tennessee, United States

Site Status

Vanderbilt University Medical Center Clinical Trials Center

Nashville, Tennessee, United States

Site Status

Kidney Associates

Houston, Texas, United States

Site Status

Centre Point Dialysis

West Allis, Wisconsin, United States

Site Status

RCMI- Clinical Research Center Medical Sciences Campus University of Puerto Rico

Rio Piedras, PR, Puerto Rico

Site Status

Countries

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United States Puerto Rico

References

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Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.

Reference Type DERIVED
PMID: 40576086 (View on PubMed)

Dwyer JP, Sika M, Schulman G, Chang IJ, Anger M, Smith M, Kaplan M, Zeig S, Koury MJ, Blumenthal SS, Lewis JB; Collaborative Study Group. Dose-response and efficacy of ferric citrate to treat hyperphosphatemia in hemodialysis patients: a short-term randomized trial. Am J Kidney Dis. 2013 May;61(5):759-66. doi: 10.1053/j.ajkd.2012.11.041. Epub 2013 Jan 29.

Reference Type DERIVED
PMID: 23369827 (View on PubMed)

Other Identifiers

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KRX-0502-305

Identifier Type: -

Identifier Source: org_study_id