NCT05124444

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2015

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 29, 2019

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 29, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 2021

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
Last Updated

November 18, 2021

Status Verified

November 1, 2021

Enrollment Period

4.2 years

First QC Date

November 1, 2021

Last Update Submit

November 10, 2021

Conditions

Kidney Transplantation

Outcome Measures

Primary Outcomes (1)

  • Number of moderately to highly damaging exonic variants

    Through study completion, an average of 2 year

Study Arms (2)

Cases (tolerant patients)

EXPERIMENTAL
Genetic: High throughput DNA and RNA sequencing

Controls

EXPERIMENTAL
Genetic: High throughput DNA and RNA sequencing

Interventions

High throughput DNA and RNA sequencingGENETIC

High throughput DNA and RNA sequencing

Cases (tolerant patients)Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 37265662DERIVED

MeSH Terms

Interventions

Sequence Analysis, RNA

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: 1. Exome-wide association study 2. Transcriptomic analyses
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 1, 2021

First Posted

November 18, 2021

Study Start

August 22, 2015

Primary Completion

October 29, 2019

Study Completion

September 29, 2021

Last Updated

November 18, 2021

Record last verified: 2021-11