- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00276289
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Department of Medicine, Division of Nephrology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Change in serum potassium on spironolactone versus off of it
|
Secondary Outcome Measures
Outcome Measure |
---|
change in urinary calcium excretion
|
mean reduction in dose of potassium supplements
|
Collaborators and Investigators
Investigators
- Principal Investigator: Sharon S Moe, MD, Indiana University
Study record dates
Study Major Dates
Study Start
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Metabolic Diseases
- Urological Manifestations
- Nutrition Disorders
- Deficiency Diseases
- Malnutrition
- Water-Electrolyte Imbalance
- Hypercalciuria
- Hypokalemia
- Potassium Deficiency
- Physiological Effects of Drugs
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Natriuretic Agents
- Diuretics
- Hormone Antagonists
- Mineralocorticoid Receptor Antagonists
- Diuretics, Potassium Sparing
- Spironolactone
Other Study ID Numbers
- 0509-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Idiopathic Hypercalciuria
-
Agnieszka PozdzikCompletedHypercalciuria; IdiopathicBelgium
-
University of ChicagoTerminatedOsteoporosis | Osteopenia | Hypercalciuria | Hypercalciuria, Familial IdiopathicUnited States
-
Hospital Infantil de Mexico Federico GomezUnknownComparison of the Impact of Diet vs Thiazide in BMD in Children With Idiopathic Hypercalciuria (HIC)Nephrolithiasis | Hypercalciuria; IdiopathicMexico
-
University Hospital, MontpellierRecruiting
-
New York Presbyterian HospitalCompletedNephrolithiasis | Vitamin D Deficiency | Urolithiasis | Idiopathic Hypercalciuria | Disorder of Vitamin DUnited States
-
Hospices Civils de LyonCompletedIdiopathic Hypercalciuria | Primary Hyperoxaluria Type 1France
-
Children's Hospital of PhiladelphiaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)RecruitingGenetic Disease | Hypercalciuria | Idiopathic Infantile Hypercalcemia - Mild Form | Idiopathic Infantile Hypercalcaemia - Severe Form | Hypercalcemia, Idiopathic, of Infancy | Hypercalciuric HypercalcemiaUnited States
-
University of ParmaCatholic University of the Sacred Heart; University of Milan; Università Vita-Salute...Completed
-
Assistance Publique - Hôpitaux de ParisMinistry of Health, FranceCompletedAutosomal Dominant Hypocalcemia OR Primary Hypoparathyroidism Related to Other Cause But Complicated by Hypercalciuria Under TreatmentFrance
-
VA New York Harbor Healthcare SystemCompleted
Clinical Trials on Spironolactone
-
Medical University of South CarolinaWithdrawn
-
Medical University of South CarolinaWithdrawnHidradenitis Suppurativa
-
Columbia UniversityCompletedHeart FailureUnited States
-
Asan Medical CenterCompletedHeart FailureKorea, Republic of
-
Yonsei UniversityWithdrawn
-
Instituto Nacional de Ciencias Medicas y Nutricion...TerminatedPatients With Fungic InfectionsMexico
-
Assistance Publique - Hôpitaux de ParisSociété de Dermatologie FrançaiseCompletedCutaneous Atrophy Due to CorticosteroidsFrance
-
Yale UniversityAmerican Heart AssociationRecruitingRegulating Blood Pressure During Recovery From Intracerebral Hemorrhage and Ischemic Stroke (REDUCE)Ischemic Stroke | Intracerebral Hemorrhage | SpironolactoneUnited States
-
Emory UniversityCompleted
-
Instituto Nacional de Cardiologia Ignacio ChavezSuspendedKidney TransplantMexico