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

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

Official Title ^†

Brief 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.

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.

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Safety/Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Hypercalciuria
Kidney Calculi

Intervention ^†

Drug: potassium citrate
Drug: potassium phosphate

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

300

Start Date ^†

April 1995

Completion Date

Primary Completion Date

Eligibility 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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

Administrative Information Fields

NCT ID ^†

NCT00004284

Organization ID

199/11703

Secondary IDs ^††

UTSMC-039510400

Study Sponsor ^†

National Center for Research Resources (NCRR)

Collaborators ^††

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Texas

Investigators ^†

Study Chair:

Charles Y. C. Pak

University of Texas

Information Provided By

Office of Rare Diseases (ORD)

Verification Date

June 2000

First Received Date ^†

October 18, 1999

Last Updated Date

June 23, 2005

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.