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

Sponsor

Nabi Biopharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT00211978

Collaborator

(none)

110

Enrollment

Location

Arms

Duration (Months)

6.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperphosphatemia Kidney Failure	Drug: calcium acetate Drug: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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 Start Date :

May 1, 2005

Actual Primary Completion Date :

Jun 1, 2006

Actual Study Completion Date :

Oct 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: PhosLo

Drug: calcium acetate

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

Other Names:

PhosLo

Placebo Comparator: placebo

Drug: placebo

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

Outcome Measures

Primary Outcome Measures

serum phosphorus [weeks 5-24]

Secondary Outcome Measures

calcium x phosphorus product [weeks 5-24]
intact parathyroid hormone [weeks 5-24]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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