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

NCT ID: NCT05124444

Last Updated: 2021-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-22

Study Completion Date

2021-09-29

Brief Summary

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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.

Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

1. Exome-wide association study
2. Transcriptomic analyses
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cases (tolerant patients)

Group Type EXPERIMENTAL

High throughput DNA and RNA sequencing

Intervention Type GENETIC

High throughput DNA and RNA sequencing

Controls

Group Type EXPERIMENTAL

High throughput DNA and RNA sequencing

Intervention Type GENETIC

High throughput DNA and RNA sequencing

Interventions

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High throughput DNA and RNA sequencing

High throughput DNA and RNA sequencing

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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DESCARTES Working Group On Transplantation

OTHER

Sponsor Role collaborator

Université Libre de Bruxelles

OTHER

Sponsor Role lead

Responsible Party

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Annick Massart

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

References

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Massart A, Danger R, Olsen C, Emond MJ, Viklicky O, Jacquemin V, Soblet J, Duerinckx S, Croes D, Perazzolo C, Hruba P, Daneels D, Caljon B, Sever MS, Pascual J, Miglinas M; Renal Tolerance Investigators; Pirson I, Ghisdal L, Smits G, Giral M, Abramowicz D, Abramowicz M, Brouard S. An exome-wide study of renal operational tolerance. Front Med (Lausanne). 2023 May 17;9:976248. doi: 10.3389/fmed.2022.976248. eCollection 2022.

Reference Type DERIVED
PMID: 37265662 (View on PubMed)

Other Identifiers

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2015/379

Identifier Type: -

Identifier Source: org_study_id