Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2006-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Hypercalciuria Hypokalemia Caused by Thiazide Diuretics

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

nephrolithiasis hypercalciuria hypokalemia thiazide diuretics

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spironolactone

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sharon S Moe, MD

Role: PRINCIPAL_INVESTIGATOR

Indiana University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Indiana University Department of Medicine, Division of Nephrology

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

0509-05

Identifier Type: -

Identifier Source: org_study_id