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

Sponsor

Université Libre de Bruxelles (Other)

Overall Status

Completed

CT.gov ID

NCT05124444

Collaborator

DESCARTES Working Group On Transplantation (Other)

Enrollment

Arms

73.3

Actual Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Kidney Transplantation	Genetic: High throughput DNA and RNA sequencing	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Exome-wide association study Transcriptomic analysesExome-wide association study Transcriptomic analyses

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

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

Actual Study Start Date :

Aug 22, 2015

Actual Primary Completion Date :

Oct 29, 2019

Actual Study Completion Date :

Sep 29, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cases (tolerant patients)	Genetic: High throughput DNA and RNA sequencing High throughput DNA and RNA sequencing
Experimental: Controls	Genetic: High throughput DNA and RNA sequencing High throughput DNA and RNA sequencing

Arm

Intervention/Treatment

Experimental: Cases (tolerant patients)

Genetic: High throughput DNA and RNA sequencing

High throughput DNA and RNA sequencing

Experimental: Controls

Genetic: High throughput DNA and RNA sequencing

High throughput DNA and RNA sequencing

Outcome Measures

Primary Outcome Measures

Number of moderately to highly damaging exonic variants [Through study completion, an average of 2 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Université Libre de Bruxelles
DESCARTES Working Group On Transplantation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Annick Massart, Principal investigator, Université Libre de Bruxelles

ClinicalTrials.gov Identifier:

NCT05124444

Other Study ID Numbers:

2015/379

First Posted:

Nov 18, 2021

Last Update Posted:

Nov 18, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Nov 18, 2021