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NCT00004284 Clinical Trial

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

Kidney Calculi Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004284
Other study ID # 199/11703
Secondary ID UTSMC-039510400
Status Completed
Phase Phase 3
First received October 18, 1999
Last updated June 23, 2005
Start date April 1995

Study information
Verified date June 2000
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• potassium citrate

• potassium phosphate

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Texas
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