Recurrent AA Amyloidosis After Renal Transplantation

Completed

• Conditions: AA Amyloidosis

• Registration Number: NCT02704065
• Lead Sponsor: Istanbul University

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 Timeline

• Study Start: 2016-02
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-09
• Primary Completion: 2016-10
• Study Completion: 2016-12
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-15
• Last Update Posted: 2017-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Allograft survival	1 - 5 years

Secondary Outcome Measures

Name	Time	Method
Allograft rejection	1 - 5 years

Trial Locations

Locations (4)

Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine; 🇹🇷 Bursa, Turkey

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine; 🇹🇷 Istanbul, Turkey

Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine; 🇹🇷 Istanbul, Turkey

Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital; 🇹🇷 Istanbul, Turkey