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Treatment for Calcium Phosphate Kidney Stone Disease

Primary Purpose

Calcium Phosphate Kidney Stones

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo
Citric Acid
Potassium Citrate
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Calcium Phosphate Kidney Stones focused on measuring calcium phosphate, urolithiasis, kidney stones, hypercalciuria

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UT Southwestern Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

Placebo

Citric Acid

Potassium Citrate

Arm Description

Placebo tablets twice daily

Citric acid tablets twice daily

Potassium Citrate tablets twice daily

Outcomes

Primary Outcome Measures

Urinary calcium phosphate saturation

Secondary Outcome Measures

Full Information

First Posted
December 14, 2012
Last Updated
February 16, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01754779
Brief Title
Treatment for Calcium Phosphate Kidney Stone Disease
Official Title
Pharmacological Therapy for Calcium Phosphate Urolithiasis
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
July 2012 (Actual)
Primary Completion Date
February 16, 2023 (Actual)
Study Completion Date
February 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Calcium Phosphate Kidney Stones
Keywords
calcium phosphate, urolithiasis, kidney stones, hypercalciuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablets twice daily
Arm Title
Citric Acid
Arm Type
Active Comparator
Arm Description
Citric acid tablets twice daily
Arm Title
Potassium Citrate
Arm Type
Active Comparator
Arm Description
Potassium Citrate tablets twice daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo for both aims.
Intervention Type
Dietary Supplement
Intervention Name(s)
Citric Acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Potassium Citrate
Primary Outcome Measure Information:
Title
Urinary calcium phosphate saturation
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naim M Maalouf, MD
Organizational Affiliation
UT Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UT Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390-8885
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30036516
Citation
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.
Results Reference
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Treatment for Calcium Phosphate Kidney Stone Disease

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