Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics - Full Text View

Purpose

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.

Condition	Intervention
Idiopathic Hypercalciuria Hypokalemia Caused by Thiazide Diuretics	Drug: Spironolactone

MedlinePlus related topics:

Dietary Supplements

ChemIDplus related topics:

Spironolactone Potassium chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Crossover Assignment, Efficacy Study

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

Further study details as provided by Indiana University:

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

Estimated Enrollment:	10
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2006

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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00276289

Contacts


Contact: Harlan C Rust, MD	317 278-2868	hcrust@iupui.edu

Contact: Sharon Moe, MD	317 278-2868	smoe@iupui.edu

Locations


United States, Indiana
	Indiana University Department of Medicine, Division of Nephrology	Recruiting
	Indianapolis, Indiana, United States, 46202
	Contact: Harlan C Rust, MD 317-278-2868 hcrust@iupui.edu

Sponsors and Collaborators

Indiana University School of Medicine

Investigators


Principal Investigator:	Sharon S Moe, MD	Indiana University

More Information

Study ID Numbers:	0509-05
First Received:	January 11, 2006
Last Updated:	May 25, 2006
ClinicalTrials.gov Identifier:	NCT00276289
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

nephrolithiasis

hypercalciuria

hypokalemia

thiazide diuretics

Study placed in the following topic categories:

Bartter's syndrome

Metabolic Diseases

Adrenal Gland Diseases

Endocrine System Diseases

Adrenocortical Hyperfunction

Spironolactone

Signs and Symptoms

Urologic Diseases

Hypokalemia

Hypercalciuria

Water-Electrolyte Imbalance

Endocrinopathy

Kidney Diseases

Metabolic disorder

Nephrolithiasis

Bartter Syndrome

Hyperaldosteronism

Additional relevant MeSH terms:

Urological Manifestations

Aldosterone Antagonists

Natriuretic Agents

Therapeutic Uses

Hormone Antagonists

Physiological Effects of Drugs

Diuretics

Hormones, Hormone Substitutes, and Hormone Antagonists

Cardiovascular Agents

Renal Tubular Transport, Inborn Errors

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

Sponsored by:	Indiana University School of Medicine
Information provided by:	Indiana University
ClinicalTrials.gov Identifier:	NCT00276289