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

Nabi Biopharmaceuticals

Status and phase

Completed

Phase 3

Conditions

Kidney Failure

Hyperphosphatemia

Treatments

Drug: placebo

Drug: calcium acetate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00211978

EUDRACT# 2005-002565-36

Nabi 6402

Details and patient eligibility

About

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.

Full 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.

Enrollment

110 patients

Sex

All

Ages

18+ years old

Volunteers

No 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