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Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00276289
Enrollment
10
Registered
2006-01-13
Start date
2006-01-31
Completion date
2006-06-30
Last updated
2009-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypokalemia Caused by Thiazide Diuretics, Idiopathic Hypercalciuria

Keywords

nephrolithiasis, hypercalciuria, hypokalemia, thiazide diuretics

Brief 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.

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.

Interventions

DRUGSpironolactone

Sponsors

Indiana University School of Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frame
Change in serum potassium on spironolactone versus off of it

Secondary

MeasureTime frame
change in urinary calcium excretion
mean reduction in dose of potassium supplements

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026