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