CompletedPhase 4

The Effects of Spironolactone on Calcineurin Inhibitor Induced Nephrotoxicity

Denmark188 participantsStarted 2013-02

Plain-language summary

The purpose of this study is to assess whether the diuretic drug spironolactone can prevent chronic damage to transplanted kidneys caused by the medication that prevents rejection. Spironolactone prevents the effects of the hormone aldosterone. Aldosterone is suspected of being involved in the processes leading to chronic rejection of transplanted kidneys. Hence, by blocking the effects of aldosterone we hope to be able to prevent loss of kidney function in transplant patients.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Age \> 18 years
✓. Proteinuria \< 3 g/24 hours
✓. Creatinine clearance ≥ 30 mL/min
✓. S-Potassium \< 5,5 mmol/L
✓. Negative pregnancy test at the inclusion and anticonception

Exclusion criteria

✕. Intolerance to spironolactone
✕. Creatinine clearance \< 30 ml/min
✕. S-Potassium ≥ 5,5 mmol/L
✕. Resin or digoxine treatment
✕. Pregnancy or planned pregnancy
✕. Relevant organic, systemic or mental illness
✕. Anticipation of lack of compliance or understanding the study

What they're measuring

Change in Cr EDTA clearance

Timeframe: 0, 1 year, 2 years, 3 years

Trial details

NCT IDNCT01602861

SponsorOdense University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-04

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