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Recurrent AA Amyloidosis After Renal Transplantation

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ClinicalTrials.gov Identifier: NCT02704065
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : April 18, 2017
Sponsor:
Information provided by (Responsible Party):
Yasar Caliskan, 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.

Condition or disease
AA Amyloidosis

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 Type : Observational
Actual Enrollment : 54 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival
Actual Study Start Date : February 2016
Actual Primary Completion Date : October 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Recurrent AA amyloidosis
Renal transplant recipients with biopsy-confirmed AA amyloidosis in the renal allograft
Control group 1
Renal transplant recipients whose primary diseases are amyloidosis with no clinical or laboratory signs of recurrence in the renal allograft
Control group 2
Renal transplant recipients whose primary diseases are other than amyloidosis



Primary Outcome Measures :
  1. Allograft survival [ Time Frame: 1 - 5 years ]

Secondary Outcome Measures :
  1. Allograft rejection [ Time Frame: 1 - 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Renal transplant recipients
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704065


Locations
Turkey
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, 34093
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
Sponsors and Collaborators
Istanbul University
Investigators
Principal Investigator: Yasar Caliskan, MD Division of Nephrology, Department of Internal Medicine, Istanbul Faculty of Medicine

Publications:
Responsible Party: Yasar Caliskan, Associate Professor of Medicine, Istanbul University
ClinicalTrials.gov Identifier: NCT02704065     History of Changes
Other Study ID Numbers: 32447/199
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: April 18, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yasar Caliskan, Istanbul University:
amyloidosis
renal transplantation

Additional relevant MeSH terms:
Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases