Recurrent AA Amyloidosis After Renal Transplantation

AA Amyloidosis Clinical Trial

Official title:

Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704065
• Other study ID #: 32447/199
• Status: Completed
• Phase: N/A
• First received: March 4, 2016
• Last updated: April 15, 2017
• Start date: February 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• AA Amyloidosis
• Amyloidosis

Locations

Country	Name	City	State
Turkey	Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine	Bursa
Turkey	Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine	Istanbul
Turkey	Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine	Istanbul
Turkey	Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Kofman T, Grimbert P, Canouï-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Allograft survival		1 - 5 years
Secondary	Allograft rejection		1 - 5 years