Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials
Trial record 2 of 3 for:    "Bartter syndrome"

Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

This study has been completed.
Information provided by:
Indiana University Identifier:
First received: January 11, 2006
Last updated: December 2, 2009
Last verified: December 2009

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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: 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.


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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 identifier: NCT00276289

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

No publications provided Identifier: NCT00276289     History of Changes
Other Study ID Numbers: 0509-05
Study First Received: January 11, 2006
Last Updated: December 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
thiazide diuretics

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Cardiovascular Agents
Diuretics, Potassium Sparing
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Mineralocorticoid Receptor Antagonists
Natriuretic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses processed this record on March 03, 2015