Treatment for Calcium Phosphate Kidney Stone Disease

Calcium Phosphate Kidney Stones Clinical Trial

Official title:

Pharmacological Therapy for Calcium Phosphate Urolithiasis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01754779
• Other study ID #: 032012-058
• Secondary ID: R21DK097476-01
• Status: Completed
• Phase: Phase 2
• Start date: July 2012
• Est. completion date: February 16, 2023

Study information

• Verified date: March 2024
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: February 16, 2023
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Calcium Phosphate Kidney Stones
• Kidney Calculi
• Nephrolithiasis

Intervention

Dietary Supplement:
• Placebo
3 tablets twice daily of matching placebo during the placebo phase.
• Citric Acid
3, 10 mEq tablets of H3Cit twice daily during the H3Cit phase (60 mEq H3Cit per day)
• Potassium Citrate
2, 10 mEq K3Cit tablets and 1 placebo tablet twice daily during the K3Cit phase (40 mEq K3Cit per day)

Locations

Country	Name	City	State
United States	UT Southwestern Medical Center	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Doizi S, Poindexter JR, Pearle MS, Blanco F, Moe OW, Sakhaee K, Maalouf NM. Impact of Potassium Citrate vs Citric Acid on Urinary Stone Risk in Calcium Phosphate Stone Formers. J Urol. 2018 Dec;200(6):1278-1284. doi: 10.1016/j.juro.2018.07.039. Epub 2018 Jul 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinary Calcium Phosphate Saturation	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.	2 weeks