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Sponsors and Collaborators: |
National Center for Research Resources (NCRR) National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) University of Texas |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004284 |
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 |
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Hypercalciuria Kidney Calculi |
Drug: potassium citrate Drug: potassium phosphate |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Safety/Efficacy Study |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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 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 |
hypercalciuria nephrolithiasis rare disease renal and genitourinary disorders |
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 |
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 |