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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02704065
Other study ID # 32447/199
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
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