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

Primary Purpose

Hyperphosphatemia, Kidney Failure

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
calcium acetate
placebo
Sponsored by
Nabi Biopharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperphosphatemia focused on measuring PhosLo (Calcium acetate)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Texas Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

PhosLo

placebo

Arm Description

Outcomes

Primary Outcome Measures

serum phosphorus

Secondary Outcome Measures

calcium x phosphorus product
intact parathyroid hormone

Full Information

First Posted
September 13, 2005
Last Updated
December 26, 2007
Sponsor
Nabi Biopharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00211978
Brief Title
EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2007
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Nabi Biopharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia, Kidney Failure
Keywords
PhosLo (Calcium acetate)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PhosLo
Arm Type
Experimental
Arm Title
placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
calcium acetate
Other Intervention Name(s)
PhosLo
Intervention Description
667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)
Primary Outcome Measure Information:
Title
serum phosphorus
Time Frame
weeks 5-24
Secondary Outcome Measure Information:
Title
calcium x phosphorus product
Time Frame
weeks 5-24
Title
intact parathyroid hormone
Time Frame
weeks 5-24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wajeh Y Qunibi, M.D.
Organizational Affiliation
University of Texas Health Science Center, San Antonio
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas Health Sciences Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3900
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21324193
Citation
Qunibi W, Winkelmayer WC, Solomon R, Moustafa M, Kessler P, Ho CH, Greenberg J, Diaz-Buxo JA. A randomized, double-blind, placebo-controlled trial of calcium acetate on serum phosphorus concentrations in patients with advanced non-dialysis-dependent chronic kidney disease. BMC Nephrol. 2011 Feb 16;12:9. doi: 10.1186/1471-2369-12-9.
Results Reference
derived

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

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