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Mineralocorticoid Receptor Antagonist and Kidney Allograft Histology

NCT01510795 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2012-01-18

No results posted yet for this study

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.

Conditions

  • Kidney Failure, Chronic

Interventions

DRUG

spironolactone

Spironolactone initiated at 3 months posttransplant at 25 mg qd and up-titrated to 50 mg qd after 14 days. Spironolactone therapy will be maintained for 9 months.

Sponsors & Collaborators

  • Clinical Hospital Merkur

    lead OTHER

Principal Investigators

  • Bojana Maksimović, MD · Clinical Hospital Merkur

  • Mladen Knotek, MD, PhD · Clinical Hospital Merkur

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2013-06-30
Completion
2014-01-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01510795 on ClinicalTrials.gov