Recurrent AA Amyloidosis After Renal Transplantation

NCT ID: NCT02704065

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2016-12-31

Brief Summary

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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

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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.

Conditions

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AA Amyloidosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Recurrent AA amyloidosis

Renal transplant recipients with biopsy-confirmed AA amyloidosis in the renal allograft

No interventions assigned to this group

Control group 1

Renal transplant recipients whose primary diseases are amyloidosis with no clinical or laboratory signs of recurrence in the renal allograft

No interventions assigned to this group

Control group 2

Renal transplant recipients whose primary diseases are other than amyloidosis

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul University

OTHER

Sponsor Role lead

Responsible Party

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Yasar Caliskan

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasar Caliskan, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Locations

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Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine

Bursa, , Turkey (Türkiye)

Site Status

Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Division of Nephrology, Department of Internal Medicine, Cerrahpasa Faculty of Medicine

Istanbul, , Turkey (Türkiye)

Site Status

Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 21714848 (View on PubMed)

Other Identifiers

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32447/199

Identifier Type: -

Identifier Source: org_study_id

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