Idiopathic HypercalciuriaNCT00276289
Spironolactone to Decrease Potassium Wasting in Hypercalciurics on Thiazides Diuretics
A study testing Spironolactone in people with Idiopathic Hypercalciuria and Hypokalemia Caused by Thiazide Diuretics, run by Indiana University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Hypercalciuria, Hypokalemia Caused by Thiazide Diuretics
- What is being tested?
- Spironolactone
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2006to Jun 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University Department of Medicine, Division of Nephrology
Indianapolis, Indiana, 46202
About this study
Official title: Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
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.
Read the 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.
- Being tested
- Spironolactone
- Keywords
- nephrolithiasis, hypercalciuria, hypokalemia, thiazide diuretics
- Medical subject headings
- Nephrolithiasis, Hypercalciuria, Hypokalemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SpironolactoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startJan 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic HypercalciuriaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Investigators
- Sharon S Moe, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276289
- Sponsor's protocol ID
- 0509-05
- Status last verified
- Dec 2009
- First submitted
- 11 Jan 2006
- Last updated
- 3 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spironolactone to Decrease Potassium Wasting in Hypercalciuric Patients Treated With Thiazide Diuretics
- ClinicalTrials.gov ID
- NCT00276289
- Acronym / sponsor ID
- 0509-05
- Keywords
- nephrolithiasis, hypercalciuria, hypokalemia, thiazide diuretics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Jan 2006
- Study completion
- Jun 2006 (actual)
- First posted
- 13 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spironolactone | Drug | – |
Primary outcome
Change in serum potassium on spironolactone versus off of it
2 secondary outcomes
change in urinary calcium excretion
mean reduction in dose of potassium supplements
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sharon S Moe, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spironolactone in people with Idiopathic Hypercalciuria and Hypokalemia Caused by Thiazide Diuretics, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum potassium on spironolactone versus off of it. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2009.