NCT02700516

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2016

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
25 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 5, 2016

Status Verified

April 1, 2016

Enrollment Period

1 year

First QC Date

February 25, 2016

Last Update Submit

April 3, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Allograft survival

    1 - 5 years

Secondary Outcomes (1)

  • Allograft rejection

    1 - 5 years

Study Arms (3)

Recurrent GN

Renal transplant recipients with biopsy-confirmed recurrent primary glomerulonephritis.

Non-recurrent GN

Renal transplant recipients with non-recurrent primary glomerulonephritis.

Non-GN

Renal transplant recipients with etiologies other than primary glomerulonephritis.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant recipients

You may qualify if:

  • 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)

You may not qualify if:

  • Patients who are unwilling or unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

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

Istanbul, 34093, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

Related 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. doi: 10.1056/NEJMoa013036.

    PMID: 12110738BACKGROUND

MeSH Terms

Conditions

Glomerulonephritis

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Yasar Caliskan, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

February 25, 2016

First Posted

March 7, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

April 1, 2016

Last Updated

April 5, 2016

Record last verified: 2016-04

Locations