EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)

December 26, 2007 updated by: Nabi Biopharmaceuticals

EPIC (Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease): A Prospective, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel Arm, Study of PhosLo on Phosphorus Levels in Subjects With Chronic Kidney Disease

The purpose of this study is to determine if calcium acetate (PhosLo) can control serum phosphorus in pre-dialysis patients with moderate to severe impairment of kidney function.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In patients with impaired kidney function, dietary phosphorus can not be completely excreted, which leads to elevated levels of serum phosphorus. Elevated serum phosphorus leads to increased levels of parathyroid hormone (PTH), and is associated with bone disease and other adverse consequences such as soft-tissue and vascular calcification, and increased morbidity and mortality. It is therefore important to prevent hyperphosphatemia and maintain serum phosphorus levels within the range recommended by K/DOQI. In patients on dialysis, phosphate binders are routinely used to control serum phosphorus by absorbing dietary phosphate during the transit through the intestine. However, the use of phosphate binders for non-dialyzed patients with chronic kidney disease (CKD) is not an FDA approved indication, although some physicians treat patients prior to dialysis based on clinical judgment. The goal of this study is to demonstrate the efficacy of calcium acetate (PhosLo) in controlling serum phosphorus in patients with moderate to severe decrease in kidney function.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • San Antonio, Texas, United States, 78229-3900
        • University of Texas Health Sciences Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Non-dialyzed male or female patients with CKD, with a GFR of less than 30mL/min/1.73m² who have elevated serum phosphorus or who develop elevated serum phosphorus following washout from phosphorus-binding therapy.
  • Patients must have written informed consent
  • Negative serum pregnancy test if appropriate
  • Expected to be able to comply with protocol procedures and schedule

Exclusion Criteria:

  • Unstable angina pectoris
  • Severe congestive heart failure
  • Severe liver dysfunction
  • Severe malnutrition
  • Severe hyperparathyroidism
  • AIDS (HIV positive subjects without AIDS are not excluded)
  • Active malignancy for which the subject is receiving chemotherapy or radiation
  • Subject unlikely to complete the study
  • History of obstructed bowels or hypersensitivity to any of the study medications or their components
  • History of swallowing disorders such as dysphagia (that would prevent the subject from taking the study drug) severe gastrointestinal motility disorders, or major GI tract surgery
  • Participation in an investigational drug or device trial within 30 days of randomization
  • Subjects on Vitamin D therapy
  • Subjects with acute symptoms, in the last month, or current radiographic evidence of kidney stones
  • Subjects who have undergone renal transplant or receiving dialysis
  • Or any condition with makes patient participation not in the patients best interest

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Drug: placebo
gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)
Experimental: PhosLo
Drug: calcium acetate
667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
Other Names:
  • PhosLo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
serum phosphorus
Time Frame: weeks 5-24
weeks 5-24

Secondary Outcome Measures

Outcome Measure
Time Frame
calcium x phosphorus product
Time Frame: weeks 5-24
weeks 5-24
intact parathyroid hormone
Time Frame: weeks 5-24
weeks 5-24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nabi Biopharmaceuticals

Investigators

  • Study Chair: Wajeh Y Qunibi, M.D., University of Texas Health Science Center, San Antonio

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 16, 2005

First Posted (Estimate)

September 21, 2005

Study Record Updates

Last Update Posted (Estimate)

January 8, 2008

Last Update Submitted That Met QC Criteria

December 26, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Nabi 6402
  • EUDRACT# 2005-002565-36

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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