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Trial record 2 of 3 for:    "Bartter syndrome"

Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00276289
First Posted: January 13, 2006
Last Update Posted: December 3, 2009
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. Read our disclaimer for details.
Information provided by:
Indiana University
  Purpose
Kidney stone formation due to an excess of calcium in the urine is a common problem. It is treated with thiazide diuretics. These drugs often cause excessively low blood potassium levels that in turn require large doses of potassium supplements. These supplements are often large, unpleasant and easy to forget. We are trying the addition of spironolactone to these patients' medications to see if it allows them to take a lower dose of potassium.

Condition Intervention
Idiopathic Hypercalciuria Hypokalemia Caused by Thiazide Diuretics Drug: Spironolactone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Change in serum potassium on spironolactone versus off of it

Secondary Outcome Measures:
  • change in urinary calcium excretion
  • mean reduction in dose of potassium supplements

Estimated Enrollment: 10
Study Start Date: January 2006
Study Completion Date: June 2006
Detailed Description:

See rationale above

Ten patients who have had multiple kidney stones primarily due to hypercalciuria and who are currently on stable dose of thiazide or thiazide plus amiloride will be enrolled in the study. In addition, pts have to require at least 60mEq of K supplementation a day or be on 40mEq and be hypokalemic and unable to tolerate increased K supplements. We will then give them 50mg a day of spironolactone for four weeks. A complete 24-hour urine stone profile will be obtained before and after the drug is administered. After four weeks the patients' serum potassium will be rechecked, and their dose will be lowered according to a nomogram.

Primary end point is the mean change in serum K before and after spironolactone. Secondary endpoints are the change in urine calcium on and off the drug and the mean reduction in K dose on the drug.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18-65
  • History of idiopathic hypercalciuria (>200mg per 24 hours or a Ca/cr ratio of >140) felt to be the primary etiology of patient's kidney stones
  • History of at least three kidney stone events
  • On same dose of thiazide diuretic for at least three months
  • On stable dose of K 60mEq or more a day to maintain serum K >3.5 or unable to tolerate an increase in K supplement with dose at least 40mEq a day

Exclusion Criteria:

  • Use of ACE inhibitor, ACE receptor blocker or other medication known to effect serum potassium levels
  • GFR <80 by MDRD equation
  • Serious cardiac disease, diabetes, CKD , current or planned pregnancy or breastfeeding
  • History of hypertension
  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): NCT00276289


Locations
United States, Indiana
Indiana University Department of Medicine, Division of Nephrology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Principal Investigator: Sharon S Moe, MD Indiana University
  More Information

ClinicalTrials.gov Identifier: NCT00276289     History of Changes
Other Study ID Numbers: 0509-05
First Submitted: January 11, 2006
First Posted: January 13, 2006
Last Update Posted: December 3, 2009
Last Verified: December 2009

Keywords provided by Indiana University:
nephrolithiasis
hypercalciuria
hypokalemia
thiazide diuretics

Additional relevant MeSH terms:
Bartter Syndrome
Hypercalciuria
Hypokalemia
Potassium Deficiency
Urological Manifestations
Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Hyperaldosteronism
Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Diuretics
Spironolactone
Sodium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Mineralocorticoid Receptor Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Diuretics, Potassium Sparing
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action