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Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria
This study has been completed.
First Received: October 18, 1999   Last Updated: June 23, 2005   History of Changes
Sponsors and Collaborators: National Center for Research Resources (NCRR)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Texas
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004284
  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 III

Drug Information available for: Citric acid Potassium citrate Sodium Citrate Potassium chloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Safety/Efficacy Study

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
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

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

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

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Diuretics
Citric Acid
Rare Diseases
Potassium phosphate
Cardiovascular Agents
Calculi
Signs and Symptoms
Potassium Citrate
Urologic Diseases
Expectorants
Hypercalciuria
Kidney Diseases
Nephrolithiasis
Kidney Calculi

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

ClinicalTrials.gov processed this record on May 07, 2009