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Treatment for Calcium Phosphate Kidney Stone Disease

This study is currently recruiting participants.
Verified October 2016 by Naim Maalouf, University of Texas Southwestern Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT01754779
First Posted: December 21, 2012
Last Update Posted: October 31, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center
  Purpose
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.

Condition Intervention Phase
Calcium Phosphate Kidney Stones Drug: Placebo Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacological Therapy for Calcium Phosphate Urolithiasis

Resource links provided by NLM:


Further study details as provided by Naim Maalouf, University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Urinary calcium phosphate saturation [ Time Frame: 2 weeks ]

Estimated Enrollment: 50
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)
Arms Assigned Interventions
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.
Drug: Placebo
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.
Drug: Placebo
Matching placebo for both aims.
Dietary Supplement: Citric Acid Dietary Supplement: Potassium Citrate Drug: Indapamide
Aim 2

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01754779


Contacts
Contact: Ann Heard-Sakhaee, RN 214-648-4893 ann.heard-sakhaee@utsouthwestern.edu

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390-8885
Contact: Naim M Maalouf, MD         
Sponsors and Collaborators
University of Texas Southwestern Medical Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Naim M Maalouf, MD UT Southwestern Medical Center
  More Information

Responsible Party: Naim Maalouf, Associate Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01754779     History of Changes
Other Study ID Numbers: 032012-058
R21DK097476-01 ( U.S. NIH Grant/Contract )
First Submitted: December 14, 2012
First Posted: December 21, 2012
Last Update Posted: October 31, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Naim Maalouf, University of Texas Southwestern Medical Center:
calcium phosphate
urolithiasis
kidney stones
hypercalciuria

Additional relevant MeSH terms:
Kidney Calculi
Nephrolithiasis
Urolithiasis
Kidney Diseases
Urologic Diseases
Urinary Calculi
Calculi
Pathological Conditions, Anatomical
Calcium, Dietary
Citric Acid
Potassium Citrate
Indapamide
Bone Density Conservation Agents
Physiological Effects of Drugs
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Expectorants
Respiratory System Agents
Antihypertensive Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators


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