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Treatment for Calcium Phosphate Kidney Stone Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
Naim Maalouf, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01754779
First received: December 14, 2012
Last updated: December 18, 2012
Last verified: December 2012
  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 Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Pharmacological Therapy for Calcium Phosphate Urolithiasis

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Urinary calcium phosphate saturation [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Calcium Phosphate stone formers without hypercalciuria
In this double-blind, placebo-controlled, crossover study, 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
In this double-blind, placebo-controlled crossover study, 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

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01754779

Contacts
Contact: Reena John, RN 214-648-0399 Reena.John@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
Investigators
Principal Investigator: Naim M Maalouf, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: Naim Maalouf, Assistant Professor of Medicine, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01754779     History of Changes
Other Study ID Numbers: 032012-058, R21DK097476-01
Study First Received: December 14, 2012
Last Updated: December 18, 2012
Health Authority: United States: Federal Government
United States: Institutional Review Board
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Nephrolithiasis
Kidney Calculi
Calculi
Kidney Diseases
Pathological Conditions, Anatomical
Urinary Calculi
Urolithiasis
Urologic Diseases
Calcium, Dietary
Citric Acid
Potassium Citrate
Anticoagulants
Bone Density Conservation Agents
Cardiovascular Agents
Chelating Agents
Diuretics
Expectorants
Hematologic Agents
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Respiratory System Agents
Sequestering Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 19, 2014