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

This study has been completed.
Sponsor:
Information provided by:
Nabi Biopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00211978
First received: September 13, 2005
Last updated: December 26, 2007
Last verified: December 2007
History of Changes
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

U.S. FDA Resources

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

No publications provided by Nabi Biopharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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

Keywords provided by Nabi Biopharmaceuticals:
PhosLo (Calcium acetate)

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency
Hyperphosphatemia
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
 Phosphorus Metabolism Disorders
Metabolic Diseases
Calcium acetate
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013