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

November 10, 2021 updated by: Annick Massart, Université Libre de Bruxelles
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of moderately to highly damaging exonic variants
Time Frame: Through study completion, an average of 2 year
Through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université Libre de Bruxelles

Collaborators

DESCARTES Working Group On Transplantation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 22, 2015

Primary Completion (ACTUAL)

October 29, 2019

Study Completion (ACTUAL)

September 29, 2021

Study Registration Dates

First Submitted

November 1, 2021

First Submitted That Met QC Criteria

November 10, 2021

First Posted (ACTUAL)

November 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

November 18, 2021

Last Update Submitted That Met QC Criteria

November 10, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2015/379

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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