Clinical trial NCT02704065: Recurrent AA Amyloidosis After Renal Transplantation
Official title: Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: AA Amyloidosis
Keywords: amyloidosis
renal transplantation
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2016-03-09
Enrollment: 54
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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Allograft survival
timeFrame: 1 - 5 years
Secondary outcomes:
measure: Allograft rejection
timeFrame: 1 - 5 years
Other outcomes:
Locations:
city: Bursa
country: Turkey
facility: Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine
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
city: Istanbul
country: Turkey
facility: Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital
Study officials:
affiliation: Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine
name: Yasar Caliskan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kofman T, Grimbert P, Canoui-Poitrine F, Zuber J, Garrigue V, Mousson C, Frimat L, Kamar N, Couvrat G, Bouvier N, Albano L, Le Thuaut A, Pillebout E, Choukroun G, Couzi L, Peltier J, Mariat C, Delahousse M, Buchler M, Le Pogamp P, Bridoux F, Pouteil-Noble C, Lang P, Audard V. Renal transplantation in patients with AA amyloidosis nephropathy: results from a French multicenter study. Am J Transplant. 2011 Nov;11(11):2423-31. doi: 10.1111/j.1600-6143.2011.03620.x. Epub 2011 Jun 30.