Treatment for Calcium Phosphate Kidney Stone Disease
|Calcium Phosphate Kidney Stones||Drug: Placebo Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
|Official Title:||Pharmacological Therapy for Calcium Phosphate Urolithiasis|
- Urinary calcium phosphate saturation [ Time Frame: 2 weeks ]
|Study Start Date:||July 2012|
|Estimated Study Completion Date:||July 2018|
|Estimated Primary Completion Date:||July 2018 (Final data collection date for primary outcome measure)|
Placebo Comparator: Calcium Phosphate stone formers without hypercalciuria
Each subject will undergo 3 phases, the order of which will be randomized by a simple randomization scheme. The 3 phases will be Placebo, Citric Acid, and Potassium Citrate. Each phase will be 1 week in duration, during which subjects will take assigned study medications. A 1-week washout period is imposed between phases.
Matching placebo for both aims.Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate
Placebo Comparator: Calcium Phosphate stone formers with hypercalciuria
Each hypercalciuric CaP stone former will undergo 3 phases, the order of which will be randomized by a simple randomization scheme.
Matching placebo for both aims.Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide
We will examine in two short-term placebo-controlled cross-over metabolic studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of CaP stone formers. The first study will be conducted in hypocitraturic CaP stone formers without hypercalciuria, and will compare the effects of potassium citrate, citric acid and placebo.
The second study will be conducted in hypercalciuric CaP stone formers on a thiazide diuretic who require potassium supplementation, and will compare the effects of potassium chloride alone, potassium chloride + citric acid, and potassium citrate alone. Physicochemical assays will be applied in addition to computer-based stone risk prediction programs to assess risk of stone recurrence.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754779
|Contact: Ann Heard-Sakhaee, RNfirstname.lastname@example.org|
|United States, Texas|
|UT Southwestern Medical Center||Recruiting|
|Dallas, Texas, United States, 75390-8885|
|Contact: Naim M Maalouf, MD|
|Principal Investigator:||Naim M Maalouf, MD||UT Southwestern Medical Center|