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

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

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

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics

Resource links provided by NLM:

Genetics Home Reference related topics: Bartter syndrome carbamoyl phosphate synthetase I deficiency

MedlinePlus related topics: Dietary Supplements Kidney Stones Potassium

Drug Information available for: Spironolactone

U.S. FDA Resources

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
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

Locations

United States, Indiana
Indiana University Department of Medicine, Division of Nephrology
Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University School of Medicine

Investigators

Principal Investigator:

Sharon S Moe, MD

Indiana University

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00276289 History of Changes
Other Study ID Numbers:	0509-05
Study First Received:	January 11, 2006
Last Updated:	December 2, 2009
Health Authority:	United States: Food and Drug Administration

Keywords provided by Indiana University:

nephrolithiasis
hypercalciuria
hypokalemia
thiazide diuretics

Additional relevant MeSH terms:

Hypercalciuria
Hypokalemia
Potassium Deficiency
Bartter Syndrome
Urological Manifestations
Signs and Symptoms
Water-Electrolyte Imbalance
Metabolic Diseases
Deficiency Diseases
Malnutrition
Nutrition Disorders
Renal Tubular Transport, Inborn Errors
Kidney Diseases
Urologic Diseases
Hyperaldosteronism

Adrenocortical Hyperfunction
Adrenal Gland Diseases
Endocrine System Diseases
Diuretics
Spironolactone
Sodium Chloride Symporter Inhibitors
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Aldosterone Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Cardiovascular Agents

ClinicalTrials.gov processed this record on February 09, 2012