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NCT05124444 Clinical Trial

TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material

Kidney Transplantation Clinical Trial

— TOMOGRAM  

Official title:
TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05124444
Other study ID # 2015/379
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 22, 2015
Est. completion date September 29, 2021

Study information
Verified date November 2021
Source Université Libre de Bruxelles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

TOMOGRAM is a European multicentric, prospective, experimental, controlled study that aims to increase our understanding of the causative mechanisms of operational tolerance in kidney transplantation through the achievement of several multimodal whole-genomic analysis in human biological samples.

Recruitment information / eligibility
Status Completed
Enrollment 18
Est. completion date September 29, 2021
Est. primary completion date October 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - recipient of an allogenic renal allograft, - have experienced (whatever ongoing or not) at least a whole year with blood creatinine <1.7 mg/dL and proteinuria </=1g/day or /g creatinine despite the COMPLETE discontinuation of immunosuppressive drugs, - alternatively, have experienced (whatever ongoing or not) at least a whole year with stable blood creatinine (max 20% variation) and proteinuria above these criteria despite the COMPLETE discontinuation of immunosuppressive drugs Exclusion Criteria: - Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation

Study Design

Related Conditions & MeSH terms

Intervention

Genetic:
• High throughput DNA and RNA sequencing
High throughput DNA and RNA sequencing

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Université Libre de Bruxelles DESCARTES Working Group On Transplantation

Outcome
Type Measure Description Time frame Safety issue
Primary Number of moderately to highly damaging exonic variants Through study completion, an average of 2 year
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