Phase III Randomized, Double-Blind Study of Potassium Phosphate Vs Potassium Citrate for Absorptive Hypercalciuria
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Masking: Double-Blind Primary Purpose: Treatment |
Eligibility| 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
Contacts and Locations More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00004284 History of Changes |
| Other Study ID Numbers: | 199/11703, UTSMC-039510400 |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Federal Government |
Keywords provided by Office of Rare Diseases (ORD):
|
hypercalciuria nephrolithiasis rare disease renal and genitourinary disorders |
Additional relevant MeSH terms:
|
Calculi Hypercalciuria Kidney Calculi Pathological Conditions, Anatomical Urological Manifestations Signs and Symptoms Nephrolithiasis Kidney Diseases Urologic Diseases Urolithiasis Urinary Calculi Potassium phosphate |
Potassium Citrate Cariostatic Agents Protective Agents Physiological Effects of Drugs Pharmacologic Actions Diuretics Natriuretic Agents Expectorants Respiratory System Agents Therapeutic Uses Cardiovascular Agents |
ClinicalTrials.gov processed this record on June 17, 2013