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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05124444
Other study ID # 2015/379
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 22, 2015
Est. completion date September 29, 2021

Study information

Verified date November 2021
Source Université Libre de Bruxelles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date September 29, 2021
Est. primary completion date October 29, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Genetic:
High throughput DNA and RNA sequencing
High throughput DNA and RNA sequencing

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
Université Libre de Bruxelles DESCARTES Working Group On Transplantation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of moderately to highly damaging exonic variants Through study completion, an average of 2 year
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