NCT02704065

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2016

Shorter than P25 for all trials

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

8 months

First QC Date

March 4, 2016

Last Update Submit

April 15, 2017

Conditions

AA Amyloidosis

Keywords

amyloidosisrenal transplantation

Outcome Measures

Primary Outcomes (1)

  • Allograft survival

    1 - 5 years

Secondary Outcomes (1)

  • Allograft rejection

    1 - 5 years

Study Arms (3)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Renal transplant recipients

You may qualify if:

  • 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)

You may not qualify if:

  • Patients who are unwilling or unable to consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

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

Bursa, Turkey (Türkiye)

Location

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

Istanbul, 34093, Turkey (Türkiye)

Location

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

Istanbul, Turkey (Türkiye)

Location

Division of Nephrology, Sisli Hamidiye Etfal Training and Education Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • 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.

    PMID: 21714848BACKGROUND

MeSH Terms

Conditions

AA amyloidosisAmyloidosis

Condition Hierarchy (Ancestors)

Proteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yasar Caliskan, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 9, 2016

Study Start

February 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

TU(4)