drugset / Trial / NCT01510795

Mineralocorticoid Receptor Antagonist and Kidney Allograft Histology

NCT01510795

Phase 4 Unknown 40 enrolled Clinical Hospital Merkur
Non-randomizedSingle-groupOpen-labelTreatment

Summary

Chronic allograft nephropathy is one of dominant causes of long term kidney transplant failure. Its main histological determinant is interstitial fibrosis and tubular atrophy. Mechanisms of these changes are multifactorial and are not completely elucidated. Epithelial mesenchymal transition (EMT) might be one of the mechanisms. On molecular level role of renin angiotensin aldosterone system (RAAS) has been recognized. Recently, mineralocorticoid hormone aldosterone has been proposed as a possible direct contributor to the progression of renal injury and fibrosis, beside his well known role as a regulator of extracellular fluid volume and sodium and potassium balance. In this study the investigators will determine the impact of mineralocorticoid receptor antagonist use on progression of chronic scores in transplanted kidney over one year. The investigators hypothesis is that spironolactone use in kidney transplant patients will slow down progression of chronic histological changes- interstitial fibrosis, tubular atrophy and arteriolar hyalinosis.

Timeline

Start
2012-01
Primary completion
2013-06
Completion
2014-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Spironolactone Small molecule 50 mg