Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics

NCT00276289 | Completed

• 1 other identifier: 0509-05
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Idiopathic Hypercalciuria; Hypokalemia Caused by Thiazide Diuretics

Keywords

nephrolithiasis; hypercalciuria; hypokalemia; thiazide diuretics

Outcome Measures

Primary Outcomes (1)

• Change in serum potassium on spironolactone versus off of it

Secondary Outcomes (2)

• change in urinary calcium excretion

• mean reduction in dose of potassium supplements

Interventions

Spironolactone DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University School of Medicine: lead

Study Sites (1)

Indiana University Department of Medicine, Division of Nephrology

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Nephrolithiasis; Hypercalciuria; Hypokalemia

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Sharon S Moe, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 11, 2006
• First Posted: January 13, 2006
• Study Start: January 1, 2006
• Study Completion: June 1, 2006
• Last Updated: December 3, 2009

Record last verified: 2009-12

Locations

US (1)