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

Université Libre de Bruxelles

Status: Completed

Conditions: Kidney Transplantation

Treatments: Genetic: High throughput DNA and RNA sequencing

Study type: Interventional

Funder types: Other

Identifiers

NCT05124444

2015/379

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 2 patient groups

Cases (tolerant patients)

Experimental group

Treatment:

Genetic: High throughput DNA and RNA sequencing

Controls

Experimental group

Treatment:

Genetic: High throughput DNA and RNA sequencing