Treatment for Calcium Phosphate Kidney Stone Disease

Phase 2

Completed

• Conditions: Calcium Phosphate Kidney Stones

• Registration Number: NCT01754779
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

The investigators will examine in two studies whether citric acid or potassium citrate can reduce calcium phosphate saturation in urine of Calcium Phosphate stone formers.

Detailed Description

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.

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2012-12-14
• Study First Submitted QC: 2012-12-18
• Study First Posted: 2012-12-21
• Primary Completion: 2023-02-16
• Study Completion: 2023-02-16
• Results First Submitted: 2024-01-23
• Status Verified: 2024-03
• Results First Submitted QC: 2024-03-07
• Last Update Submitted: 2024-03-07
• Results First Posted: 2024-04-04
• Last Update Posted: 2024-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

Aim 1

• Hypocitraturic CaP stone formers
• urine citrate <320mg/d
• elevated pH as 24-hr urine pH above 6.40
• >21 years

Aim 2

• Hypercalciuric CaP stone formers
• 24hr urine calcium >250mg/d in women and >300mg/d in men prior to indapamide use
• high pH as >6.40 in the absence of urinary tract infection
• >21 years

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Urinary Calcium Phosphate Saturation	2 weeks	This variable represents a ratio of the calcium phosphate saturation in a given urine sample to the calcium phosphate saturation at the point of precipitation and hence this measure has no units.

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States