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Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

Information source: Indiana University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Hypercalciuria; Hypokalemia Caused by Thiazide Diuretics

Intervention: Spironolactone (Drug)

Phase: N/A

Status: Completed

Sponsored by: Indiana University School of Medicine

Official(s) and/or principal investigator(s):
Sharon S Moe, MD, Principal Investigator, Affiliation: Indiana University


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.

Clinical Details

Official title: Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics

Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in serum potassium on spironolactone versus off of it

Secondary outcome:

change in urinary calcium excretion

mean reduction in dose of potassium supplements

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.


Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.


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


- History of hypertension

Locations and Contacts

Indiana University Department of Medicine, Division of Nephrology, Indianapolis, Indiana 46202, United States
Additional Information

Starting date: January 2006
Last updated: December 2, 2009

Page last updated: August 23, 2015

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