Kidney TransplantationTOMOGRAMNCT05124444
TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material
A study testing High throughput DNA and RNA sequencing in people with Kidney Transplantation, run by Université Libre de Bruxelles.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplantation
- What is being tested?
- High throughput DNA and RNA sequencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 22 Aug 2015to 29 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation
About this study
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.
- Conditions
- Kidney Transplantation
- Being tested
- High throughput DNA and RNA sequencing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High throughput DNA and RNA sequencingGenetic
High throughput DNA and RNA sequencing
| Study group | Role | What they receive |
|---|---|---|
| Cases (tolerant patients) | Experimental | Not described Receives: Genetic: High throughput DNA and RNA sequencing |
| Controls | Experimental | Not described Receives: Genetic: High throughput DNA and RNA sequencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of moderately to highly damaging exonic variants
Measured: Through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2021
- Study start22 Aug 2015
- Primary completion29 Oct 2019
- Study completion29 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- 1. Exome-wide association study 2. Transcriptomic analyses
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université Libre de Bruxelles
- Sponsor type
- University, hospital or other
- Collaborators
- DESCARTES Working Group On Transplantation
- Responsible party
- Principal investigator, Annick Massart, Université Libre de Bruxelles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05124444
- Sponsor's protocol ID
- 2015/379
- Acronym
- TOMOGRAM
- Status last verified
- Nov 2021
- First submitted
- 1 Nov 2021
- Last updated
- 18 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37265662
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOlerance MOlecular and Genome-wide Studies With Renal Allograft Recipient Material
- ClinicalTrials.gov ID
- NCT05124444
- Acronym / sponsor ID
- TOMOGRAM / 2015/379
- Conditions
- Kidney Transplantation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Université Libre de BruxellesUniversity, hospital or other
- Collaborators
- DESCARTES Working Group On Transplantation
- Study start
- 22 Aug 2015 (actual)
- Primary completion
- 29 Oct 2019 (actual)
- Study completion
- 29 Sep 2021 (actual)
- First posted
- 18 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1. Exome-wide association study 2. Transcriptomic analyses
| Arm | Type | Receives |
|---|---|---|
| Cases (tolerant patients) | Experimental | Genetic: High throughput DNA and RNA sequencing |
| Controls | Experimental | Genetic: High throughput DNA and RNA sequencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Past medical history of allogeneic bone-marrow transplantation / combined organ transplantation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High throughput DNA and RNA sequencingHigh throughput DNA and RNA sequencing | Genetic | Cases (tolerant patients), Controls |
Primary outcome
Number of moderately to highly damaging exonic variants
Time frame: Through study completion, an average of 2 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2021.
- Derived from this study: PubMed 37265662Massart 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing High throughput DNA and RNA sequencing in people with Kidney Transplantation, run by Université Libre de Bruxelles.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of moderately to highly damaging exonic variants (time frame: Through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05124444, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2021.