Clinical trial NCT02700516: Recurrent Glomerulonephritis After Renal Transplantation
Official title: Recurrent Primary Glomerulonephritis After Renal Transplantation: Effects on Renal Allografts and Transplant Recipients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glomerulonephritis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-03-07
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Renal transplant recipients

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.

Eligibility criteria: 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

Primary outcomes:
measure: Allograft survival
timeFrame: 1 - 5 years
Secondary outcomes:
measure: Allograft rejection
timeFrame: 1 - 5 years
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
city: Istanbul
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
name: Yasar Caliskan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1056/NEJMoa013036.