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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00211978
First Posted: September 21, 2005
Last Update Posted: January 8, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Nabi Biopharmaceuticals
  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
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

Resource links provided by NLM:


Further study details as provided by Nabi Biopharmaceuticals:

Primary Outcome Measures:
  • serum phosphorus [ Time Frame: weeks 5-24 ]

Secondary Outcome Measures:
  • calcium x phosphorus product [ Time Frame: weeks 5-24 ]
  • intact parathyroid hormone [ Time Frame: weeks 5-24 ]

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

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 13, 2005
First Posted: September 21, 2005
Last Update Posted: January 8, 2008
Last Verified: December 2007

Keywords provided by Nabi Biopharmaceuticals:
PhosLo (Calcium acetate)

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