Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00276289
Status:
COMPLETED
Last Update Posted:
2009-12-03
First Post:
2006-01-11
Brief Title:
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
Sponsor:
Indiana University School of Medicine
Organization:
Indiana University
Study Overview
Official Title:
Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None