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Treatment for Calcium Phosphate Kidney Stone Disease

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ClinicalTrials.gov Identifier: NCT01754779
Recruitment Status : Recruiting
First Posted : December 21, 2012
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center

Tracking Information
First Submitted Date  ICMJE December 14, 2012
First Posted Date  ICMJE December 21, 2012
Last Update Posted Date November 15, 2018
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 18, 2012)
Urinary calcium phosphate saturation [ Time Frame: 2 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01754779 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment for Calcium Phosphate Kidney Stone Disease
Official Title  ICMJE Pharmacological Therapy for Calcium Phosphate Urolithiasis
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Calcium Phosphate Kidney Stones
Intervention  ICMJE
  • Drug: Placebo
    Matching placebo for both aims.
  • Dietary Supplement: Citric Acid
  • Dietary Supplement: Potassium Citrate
  • Drug: Indapamide
    Aim 2
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Placebo
    • 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.
    Interventions:
    • Drug: Placebo
    • Dietary Supplement: Citric Acid
    • Dietary Supplement: Potassium Citrate
    • Drug: Indapamide
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 18, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2021
Estimated Primary Completion Date July 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Ann Heard-Sakhaee, RN 214-648-4893 ann.heard-sakhaee@utsouthwestern.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01754779
Other Study ID Numbers  ICMJE 032012-058
R21DK097476-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Naim Maalouf, University of Texas Southwestern Medical Center
Study Sponsor  ICMJE University of Texas Southwestern Medical Center
Collaborators  ICMJE National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Naim M Maalouf, MD UT Southwestern Medical Center
PRS Account University of Texas Southwestern Medical Center
Verification Date November 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP