Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria

This study has been completed.
Sponsor:
Collaborators:
University of Texas
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004284
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: June 2000
  Purpose

OBJECTIVES: I. Evaluate the ability of a slow-releasing formulation of neutral potassium phosphate to correct hypercalciuria and prevent recurrent stone formation in patients with absorptive hypercalciuria.

II. Evaluate the safety of this treatment. III. Compare the efficacy of potassium phosphate to that of potassium citrate.


Condition Intervention Phase
Hypercalciuria
Kidney Calculi
Drug: potassium citrate
Drug: potassium phosphate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 300
Study Start Date: April 1995
Detailed Description:

PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution.

Patients receive potassium phosphate or potassium citrate tablets twice a day for 3 years.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Absorptive hypercalciuria Intestinal hyperabsorption of calcium, i.e.: Exaggerated calciuric response to oral calcium load OR Fractional calcium-47 absorption greater than 0.61 Calciuria greater than 200 mg/day on random and calcium-restricted diet Normal or high fasting urinary calcium Normal serum calcium Normal serum parathyroid hormone No primary hyperparathyroidism At least 1 calcium oxalate stone within the past 3 years No struvite or carbonate apatite stones No noncalcareous stones No numerous stones making precise quantitation difficult No renal tubular acidosis --Prior/Concurrent Therapy-- No concurrent drug therapy for nephrolithiasis --Patient Characteristics-- Creatinine clearance at least 0.7 mL/min per kilogram No hyperkalemia No hyperphosphatemia No urinary tract infection Other: No predisposition to hyperkalemia, including concurrent use of the following drugs: Potassium-sparing diuretics Angiotensin-converting enzyme inhibitors Nonsteroidal anti-inflammatory drugs No active peptic ulcer disease No chronic diarrhea

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004284

Sponsors and Collaborators
University of Texas
Investigators
Study Chair: Charles Y. C. Pak University of Texas
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004284     History of Changes
Other Study ID Numbers: 199/11703, UTSMC-039510400
Study First Received: October 18, 1999
Last Updated: June 23, 2005
Health Authority: United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
hypercalciuria
nephrolithiasis
rare disease
renal and genitourinary disorders

Additional relevant MeSH terms:
Calculi
Hypercalciuria
Kidney Calculi
Pathological Conditions, Anatomical
Urological Manifestations
Signs and Symptoms
Nephrolithiasis
Kidney Diseases
Urologic Diseases
Urolithiasis
Urinary Calculi
Potassium phosphate
Potassium Citrate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Diuretics
Natriuretic Agents
Expectorants
Respiratory System Agents
Therapeutic Uses
Cardiovascular Agents

ClinicalTrials.gov processed this record on August 20, 2014