EPIC(Effect of PhosLo on Phosphorus Levels in Chronic Kidney Disease) - Full Text View

Sponsored by:	Nabi Biopharmaceuticals
Information provided by:	Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00211978

Purpose

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.

Condition	Intervention	Phase
Hyperphosphatemia Kidney Failure	Drug: calcium acetate Drug: placebo	Phase III

MedlinePlus related topics: Calcium Kidney Failure

Drug Information available for: Calcium gluconate Acetic acid, calcium salt Phosphorus

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:

serum phosphorus [ Time Frame: weeks 5-24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

calcium x phosphorus product [ Time Frame: weeks 5-24 ] [ Designated as safety issue: No ]
intact parathyroid hormone [ Time Frame: weeks 5-24 ] [ Designated as safety issue: No ]

Enrollment:	110
Study Start Date:	May 2005
Study Completion Date:	October 2006
Primary Completion Date:	June 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
PhosLo: Experimental	Drug: calcium acetate 667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
placebo: Placebo Comparator	Drug: placebo gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211978

Locations

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

Sponsors and Collaborators

Nabi Biopharmaceuticals

Investigators

Study Chair:

Wajeh Y Qunibi, M.D.

University of Texas Health Science Center, San Antonio

More Information

Responsible Party:	Nabi Biopharmaceuticals ( Paul Kessler, MD, Sr. VP, Clinical, Medical, & Regulatory Affairs )
Study ID Numbers:	Nabi 6402, EUDRACT# 2005-002565-36
Study First Received:	September 13, 2005
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00211978
Health Authority:	United States: Food and Drug Administration

Keywords provided by Nabi Biopharmaceuticals:

PhosLo (Calcium acetate)

Study placed in the following topic categories:

Calcium, Dietary
Renal Insufficiency
Metabolic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic

Hyperphosphatemia
Kidney Diseases
Metabolic disorder
Calcium acetate
Kidney Failure

Additional relevant MeSH terms:

Phosphorus Metabolism Disorders
Molecular Mechanisms of Pharmacological Action
Chelating Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009