NCT01691053

Mineralocorticoid Receptor Antagonists in End Stage Renal Disease

Phase II Trial to Evaluate the Efficacy and Safety of Spironolactone in Hemodialysis Patients

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 118 (actual)
• Sponsor: Wuerzburg University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

End stage renal disease (ESRD) patients exhibit an extraordinarily high annual mortality. Cardiovascular (CV) causes account for almost half of all-cause mortality. Increased left ventricular mass (LVM) is a common finding in ESRD patients on dialysis and is an independent predictor of survival. Yet, to date there is no established medical treatment to reduce CV morbidity and mortality in ESRD patients on hemodialysis. Blockade of aldosterone action by means of mineralocorticoid receptor antagonists (MRA) provides cardioprotection and improves outcome in heart failure patients. Furthermore, the MRA spironolactone has recently been shown to reduce LVM in patients with mild-to-moderate chronic kidney disease (CKD). The investigators here hypothesize that spironolactone treatment is cardioprotective by reducing LVM in ESRD patients on dialysis.

Conditions

• End Stage Renal Disease / Hemodialysis

Interventions

Type	Name	Description
DRUG	Spironolactone	50mg once daily
DRUG	Placebo	Placebo

Timeline

• Start date: 2012-12-01
• Primary completion: 2017-02-14
• Completion: 2018-03-28
• First posted: 2012-09-24
• Last updated: 2019-08-06

Locations

3 sites across 1 country: Germany