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Clinical Trials/NCT02704065
NCT02704065
Completed
Not Applicable

Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival

Istanbul University4 sites in 1 country54 target enrollmentStarted: February 2016Last updated:
ConditionsAA Amyloidosis

Overview

Phase
Not Applicable
Status
Completed
Enrollment
54
Locations
4
Primary Endpoint
Allograft survival

Overview

Brief Summary

End-stage renal disease related to AA amyloidosis is well characterized but there is limited data concerning patient and graft outcomes after renal transplantation. The aim of this study is to evaluate the clinical features of, and risk factors for recurrent AA amyloidosis, as well as the effects of these factors on the ultimate outcome of renal allografts.

Detailed Description

AA amyloidosis is a rare but serious complication of several chronic inflammatory diseases including recurrent hereditary periodic fever syndromes. Although end-stage renal disease related to AA amyloidosis is well characterized, there is limited data concerning patient and graft outcomes after renal transplantation, with most of the findings reported from small series. Recurrence of amyloidosis in the renal allograft might be underdiagnosed, assessing graft and patient outcomes in larger study groups will bring better understanding and new strategies in daily practice.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Renal transplantation recipients whose primary renal disease is AA amyloidosis; patients with allograft biopsy-confirmed AA amyloidosis (for study group) and patients with no clinical or laboratory signs of recurrence in the renal allograft (for control group 1)
  • Renal transplantation recipients whose primary diseases are other than AA amyloidosis (for control group 2)

Exclusion Criteria

  • Patients who are unwilling or unable to consent

Outcomes

Primary Outcomes

Allograft survival

Time Frame: 1 - 5 years

Secondary Outcomes

  • Allograft rejection(1 - 5 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Yasar Caliskan

Associate Professor of Medicine

Istanbul University

Study Sites (4)

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