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

NCT ID: NCT00211978

Last Updated: 2008-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 110 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-05-31
• Study Completion Date: 2006-10-31

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.

Conditions

Hyperphosphatemia; Kidney Failure

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PhosLo

Group Type: EXPERIMENTAL

calcium acetate

Intervention Type: DRUG

667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)

Interventions

calcium acetate

667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)

Intervention Type: DRUG

placebo

gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)

Intervention Type: DRUG

Other Intervention Names

PhosLo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nabi Biopharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Nabi Biopharmaceuticals

Principal Investigators

Wajeh Y Qunibi, M.D.

Role: STUDY_CHAIR

University of Texas Health Science Center San Antonio

Locations

University of Texas Health Sciences Center

San Antonio, Texas, United States

Countries

United States

References

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)

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.

Reference Type: DERIVED

PMID: 21324193 (View on PubMed)

Other Identifiers

EUDRACT# 2005-002565-36

Identifier Type: -

Identifier Source: secondary_id

Nabi 6402

Identifier Type: -

Identifier Source: org_study_id