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Completed

NCT Number: NCT05124444

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

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.

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Key information

Conditions

Kidney Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High throughput DNA and RNA sequencing

Genetic

High throughput DNA and RNA sequencing

Primary outcomes

  1. Number of moderately to highly damaging exonic variants

    Time frame: Through study completion, an average of 2 year

Sponsors and collaborators

Lead sponsor

Université Libre de Bruxelles

Other

Collaborators

  • DESCARTES Working Group On Transplantation

Registry information

Acronym: TOMOGRAM

Important dates

Study start
2015
Primary completion
2019
Study completion
2021
First posted
Nov 18, 2021
Registry last updated
Nov 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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