Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria
Information source: Office of Rare Diseases (ORD)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypercalciuria; Kidney Calculi
Intervention: potassium citrate (Drug); potassium phosphate (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Center for Research Resources (NCRR) Official(s) and/or principal investigator(s):
Charles Y. C. Pak, Study Chair, Affiliation: University of Texas
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.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Safety/Efficacy Study
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: April 1995
Last updated: June 23, 2005
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