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

Kidney Failure Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211978
• Other study ID #: Nabi 6402
• Secondary ID: EUDRACT# 2005-00
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: December 26, 2007
• Start date: May 2005
• Est. completion date: October 2006

Study information

• Verified date: December 2007
• Source: Nabi Biopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: October 2006
• Est. primary completion date: June 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperphosphatemia
• Kidney Diseases
• Kidney Failure
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• calcium acetate
667 mg gelcaps, 1-3 t.i.d. (titrated to serum phosphorus level)
• placebo
gelcap, 1-3 t.i.d. (titrated to serum phosphorus level)

Locations

Country	Name	City	State
United States	University of Texas Health Sciences Center	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nabi Biopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum phosphorus		weeks 5-24	No
Secondary	calcium x phosphorus product		weeks 5-24	No
Secondary	intact parathyroid hormone		weeks 5-24	No