Recurrent Glomerulonephritis After Renal Transplantation

Completed

• Conditions: Glomerulonephritis

• Registration Number: NCT02700516
• Lead Sponsor: Istanbul University

Brief Summary

Glomerulonephritis (GN) is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. The exact prevalence of either recurrent or de novo GN is unknown since a considerable number of patients never undergo allograft biopsy, leaving GN underdiagnosed. The aim of this study is to evaluate the effects of recurrent GN on the prevalence, risk factors, clinicopathological features, and outcome of renal transplant recipients.

Detailed Description

Glomerulonephritis is the leading cause of end-stage renal disease in 30% to 50% of patients who receive a renal transplant. Even though recurrent or de novo posttransplant primary GN is the third most frequent cause of renal allograft loss after renal transplantation, different recurrence rates have been reported in different patient series worldwide. With the implementation of diverse and improved immunosuppressive treatment regimens and prolongation of graft survival, renal allograft loss caused by recurrent or de novo GN will be more important than ever. Data obtained from comparing patients who have recurrent primary GN against patients with non-recurrent GN and renal transplant recipients with non-GN etiology shall bring new approaches to the daily practice of managing patients with GN and renal failure, assessing them as transplant candidates and applying new therapies.

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2016-02-25
• Primary Completion: 2016-03
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Status Verified: 2016-04
• Study Completion: 2016-04
• Last Update Submitted: 2016-04-03
• Last Update Posted: 2016-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have biopsy-proven recurrent primary glomerulonephritis (Recurrent GN group)
• Patients who underwent a renal transplantation because of an end-stage renal disease caused by primary glomerulonephritis and have no signs of recurrence (Non-recurrent GN group)
• Patients who underwent a renal transplantation because of an end-stage renal disease linked to an etiology other than primary glomerulonephritis (Non-GN group)

Exclusion Criteria

• Patients who are unwilling or unable to consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Allograft survival	1 - 5 years

Secondary Outcome Measures

Name	Time	Method
Allograft rejection	1 - 5 years

Trial Locations

Locations (2)

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey

Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine; 🇹🇷 Istanbul, Turkey