Recurrent Glomerulonephritis After Renal Transplantation

Glomerulonephritis Clinical Trial

Official title:

Recurrent Primary Glomerulonephritis After Renal Transplantation: Effects on Renal Allografts and Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02700516
• Other study ID #: 32364/200
• Status: Completed
• Phase: N/A
• First received: February 25, 2016
• Last updated: April 3, 2016
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 360
• Est. completion date: April 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Glomerulonephritis

Locations

Country	Name	City	State
Turkey	Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Briganti EM, Russ GR, McNeil JJ, Atkins RC, Chadban SJ. Risk of renal allograft loss from recurrent glomerulonephritis. N Engl J Med. 2002 Jul 11;347(2):103-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allograft survival		1 - 5 years	Yes
Secondary	Allograft rejection		1 - 5 years	Yes