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Completed

NCT Number: NCT02704065

Recurrent AA Amyloidosis After Renal Transplantation

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.

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Key information

Conditions

AA Amyloidosis Amyloidosis Metabolic Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Nephrology, Department of Internal Medicine, Uludag University Faculty of Medicine, Bursa, Turkey (Türkiye)

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Allograft survival

    Time frame: 1 - 5 years

Secondary outcomes

  1. Allograft rejection

    Time frame: 1 - 5 years

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Registry information

Official study title

Recurrent AA Amyloidosis After Renal Transplantation: Effects on Allograft Survival

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 9, 2016
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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