Recurrent Glomerulonephritis After Renal Transplantation

NCT ID: NCT02700516

Last Updated: 2016-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

360 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Glomerulonephritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Recurrent GN

Renal transplant recipients with biopsy-confirmed recurrent primary glomerulonephritis.

No interventions assigned to this group

Non-recurrent GN

Renal transplant recipients with non-recurrent primary glomerulonephritis.

No interventions assigned to this group

Non-GN

Renal transplant recipients with etiologies other than primary glomerulonephritis.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Yasar Caliskan

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasar Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Locations

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Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 12110738 (View on PubMed)

Other Identifiers

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32364/200

Identifier Type: -

Identifier Source: org_study_id

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