search
Back to results

Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

Primary Purpose

Idiopathic Hypercalciuria, Hypokalemia Caused by Thiazide Diuretics

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spironolactone
Sponsored by
Indiana University School of Medicine
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Hypercalciuria focused on measuring nephrolithiasis, hypercalciuria, hypokalemia, thiazide diuretics

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Indiana University Department of Medicine, Division of Nephrology

Outcomes

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

Full Information

First Posted
January 11, 2006
Last Updated
December 2, 2009
Sponsor
Indiana University School of Medicine
search

1. Study Identification

Unique Protocol Identification Number
NCT00276289
Brief Title
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
Official Title
Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Indiana University School of Medicine

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Hypercalciuria, Hypokalemia Caused by Thiazide Diuretics
Keywords
nephrolithiasis, hypercalciuria, hypokalemia, thiazide diuretics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Spironolactone
Primary Outcome Measure Information:
Title
Change in serum potassium on spironolactone versus off of it
Secondary Outcome Measure Information:
Title
change in urinary calcium excretion
Title
mean reduction in dose of potassium supplements

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sharon S Moe, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Department of Medicine, Division of Nephrology
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

We'll reach out to this number within 24 hrs