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    
Contact: Harlan C Rust, MD     317 278-2868     hcrust@iupui.edu    
Contact: Sharon Moe, MD     317 278-2868     smoe@iupui.edu    
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    
Indiana University School of Medicine
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
Adrenal Gland Diseases
Adrenocortical Hyperfunction
Spironolactone
Hypokalemia
Hypercalciuria
Water-Electrolyte Imbalance
Kidney Diseases
Endocrinopathy
Metabolic disorder
Nephrolithiasis
Bartter Syndrome
Hyperaldosteronism

Additional relevant MeSH terms:
Bartter Syndrome
Metabolic Diseases
Hormone Antagonists
Diuretics
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Endocrine System Diseases
Cardiovascular Agents
Renal Tubular Transport, Inborn Errors
Pharmacologic Actions
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Aldosterone Antagonists
Natriuretic Agents
Therapeutic Uses

Source: National Library of Medicine (NLM) July 03, 2008

  


 
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