Mineralocorticoid Receptor Antagonist and Kidney Allograft Histology

NCT01510795 | Unknown Phase 4

• 1 other identifier: CHMN1012
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Kidney transplantation; Mineralocorticoid receptors; Spironolactone

Outcome Measures

Primary Outcomes (1)

• Difference in 6-month changes in chronic Banff scores between spironolactone and retrospective control group

  6 months

Secondary Outcomes (1)

• Difference in chronic Banff scores between spironolactone and retrospective control group at 12 months, eGFR at 6 and 12 months, urinary protein/creatinine ratio and urinary albumin/creatinine ratio at 6 and 12 months

  6-12 months

Study Arms (2)

retrospective control

NO INTERVENTION

spironolactone

ACTIVE COMPARATOR

Drug: spironolactone

Interventions

spironolactone DRUG

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.

Also known as: Aldactone

spironolactone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• kidney and kidney-pancreas recipients, including patients with delayed graft function ( DGF). DGF will be defined as the dialysis need in first 7 days after transplantation

You may not qualify if:

• Baseline plasma potassium level above 5.1 µmol/L
• Patients on ACE inhibitor or ARB-s therapy
• Patients with eGFR \< 30 ml/min (estimated by MDRD formula)
• Patents younger than 18 yr
• Patients with hypersensitivity to spironolacton

Sponsors & Collaborators

• Clinical Hospital Merkur: lead

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Spironolactone

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lactones; Organic Chemicals; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Bojana Maksimović, MD

  Clinical Hospital Merkur

  PRINCIPAL INVESTIGATOR

• Mladen Knotek, MD, PhD

  Clinical Hospital Merkur

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2012
• First Posted: January 18, 2012
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 18, 2012

Record last verified: 2012-01