An interventional study of Spironolactone in Idiopathic Hypercalciuria and Hypokalemia Caused by Thiazide Diuretics, sponsored by Indiana University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2009-12-03.
Sponsored by Indiana University School of Medicine · Not applicable, Interventional, and Treatment
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.
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.
324 studies on the registry are indexed under Nephrolithiasis; 90 are open to participants now.
This study's planned enrollment of 10 is below the median of 92 across 257 interventional studies indexed under Nephrolithiasis.
Browse Nephrolithiasis studies →Indiana University School of Medicine is the lead sponsor of 89 studies on the registry; none are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Change in serum potassium on spironolactone versus off of it
change in urinary calcium excretion
mean reduction in dose of potassium supplements
The record gives a start of Jan 2006 and a completion of Jun 2006. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Dec 2009. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Spironolactone
Indiana University School of Medicine