InfectionTAOISTNCT06829719
TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation
A study testing TTV DNAemia, EQ-5D-5L questionnaire and Biological tests in people with Infection and Cancer, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- TTV DNAemia, EQ-5D-5L questionnaire and Biological tests
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 4 sitesFrance
- Study dates
- 23 Apr 2025to 2 Feb 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult ≥ 18 years-old
- Recipient of a kidney allograft (third graft at most)
- 12 to 48 months post-transplantation
- Stable graft function (defined as: delta creatininemia over the previous 6 months < 20% and proteinuria < 30mg/mmol)
- On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids
- Detectable TTV DNAemia at enrollment
Show all 9Show fewer
- No circulating DSA in solid phase assay
- Undetectable BKV DNAemia at enrollment
- Written informed consent
Who cannot join
- Recipient of an HLA identical graft
- Mutiple organ transplantation or functional transplant other than kidney
- Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel
- Presence of histological sign of active rejection (i+t > 2 and g+cpt > 2) on graft biopsy performed within 3 months before enrollment
- Uncontrolled infection at inclusion
- Infection requiring hospitalization within 3 months before inclusion
Show all 10Show fewer
- Diagnosis of a cancer of interest between the (current) transplantation and inclusion
- Pregnant, unwillingness to practice adequate contraception or patient with a pregnancy plan during 3 years of study
- Person not affiliated to a social security scheme or beneficiary of a similar scheme
- Person subject to a legal protection measure (guardianship, curatorship) or deprived of liberty
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France4 sites, 4 recruiting
- Not yet recruiting
Service de Néphrologie-Transplantation-Dialyse I Hôpital Pellegrin I - CHU Bordeaux
Bordeaux (France), 33000
Lionel COUZI, MD, PhD, +335.56.79.55.38, lionel.couzi@chu-bordeaux.fr
- Recruiting
Service de transplantation, néphrologie et immunologie clinique Hospices Civils de Lyon, Hôpital Edouard Herriot
Lyon, 69003
Olivier THAUNAT, Professor, 04.72.11.69.28 ext. +33, olivier.thaunat@chu-lyon.fr
Olivier THAUNAT, Professor
- Not yet recruiting
Service de Néphrologie, Dialyse et Transplantation Rénale Nouvel Hôpital Civil
Strasbourg (france), 67091
Sophie CAILLARD OHLMANN, MD, PhD, +333.69.55.13.20, Sophie.OHLMANN@chru-strasbourg.fr
- Recruiting
Département de Néphrologie et Transplantation d'Organes Hôpital Rangueil - CHU de Toulouse
Toulouse (France), 31059
Nassim KAMAR, MD, PhD, +335.61.32.23.35, kamar.n@chu-toulouse.fr
About this study
Official title: Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation
Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.
Torque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.
The TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.
- Conditions
- Infection, Cancer, Rejection, Kidney Transplantation
- Being tested
- TTV DNAemia, EQ-5D-5L questionnaire, Biological tests
- Keywords
- TTV, Biomarker, immunosuppression, precision medicine, kidney transplantation
- Medical subject headings
- Infections, Neoplasms, Rejection, Psychology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TTV DNAemiaBiological
Every 6 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia
EQ-5D-5L questionnaireOther
Completed every 6 months and each time a complication of interest occurs
Biological testsBiological
Biological tests as routine care procedure (creatinine, CNI pre-dose trough level) will be performed every 6 months
| Study group | Role | What they receive |
|---|---|---|
| TTV-guided immunosuppression | Experimental | The adaptation of the dose of maintenance immunosuppressive drugs will be based on TTV DNAemia measured on site in the plasma of patients every 6 months (at distance of an infection or a vaccination). The physicians will be free to change the dose of calcineurin inhibitors (CNI) and/or the mycophenolate mofetil (MMF) to maintain TTV DNAemia between 3.8 and 5.1 log10 cp/mL as long as the trough levels remain between 3-12 ng/mL for tacrolimus (50-250 ng/mL for cyclosporin) and the daily dose of MMF is comprise between 250 and 1500 mg bid for Cellcept (180 and 900 mg for Myfortic). Receives: Biological: TTV DNAemia; Other: EQ-5D-5L questionnaire; Biological: Biological tests |
| Standard Immunosuppression | Other | TTV DNAemia will also be measured every 6 months but the results will not be communicated to the physicians. Instead, the adaptation of the dose of maintenance immunosuppressive drugs will be performed according to the current standard of care: i) the dose of the CNI will be adapted to maintain the trough levels, monitored in the circulation every 3 month, between 5-10 ng/mL for tacrolimus (75-150 ng/mL for cyclosporin) and ii) the dose of MMF will be adjusted to maintain the AUC, measured every year, between 30-60 h.mg/L. Receives: Biological: TTV DNAemia; Other: EQ-5D-5L questionnaire; Biological: Biological tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the time from randomization to first complication of inadequate immunosuppression between the experimental group, whose treatment is tailored on quarterly TTV viral load results, and the control group.
Time from randomization to occurrence of the first complication of inadequate immunosuppression: development of dnDSA, biopsy-proven rejection, infection, cancer, graft loss. Patients lost to follow-up or died without an event before will be right censored at this date.
Measured: through study completion, an average of 6 years
Secondary outcomes (8)
Proportion of patients with at least one complication of inadequate immunosuppression between the experimental and control groups at 36 months
Percentage of patients with at least one complication of inadequate immunosuppression during the 36 months of follow-up.
Measured: through study completion, an average of 6 years
Compare the rate of complications of inadequate immunosuppression between patients in the experimental and control groups.
Number of complications of inadequate immunosuppression/patient/month of follow-up
Measured: through study completion, an average of 6 years
Describe the nature and timing of various complications of inadequate immunosuppression in the experimental and control groups.
Percentage of patients (at 36 months) and time to first complication for each of the complications of interest: development of dnDSA, biopsy-proven rejection, infection, cancer, graft loss.
Measured: through study completion, an average of 6 years
Compare the proportion of patients with adequate immunosuppressive therapy between the experimental and control groups.
Percentage of patients with TTV viral load between 3.8 and 5.1 log cp/ml at the majority (>6/12) of quarterly routine controls.
Measured: through study completion, an average of 6 years
Compare the proportion of quarterly systematic checks of TTV DNAemia in the target between patients in the experimental and control groups.
Percentage of quarterly routine TTV viral load tests between 3.8 and 5.1 log cp/ml.
Measured: Every 6 months
Model the impact of variations in dose and residual rates (pre-dose trough levels or AUC) of the various immunosuppressive drugs on TTV viral load.
Joint analysis of the evolution of dose variations, residual immunosuppression rates of immunosuppressive drugs and TTV viral load.
Measured: every 6 months
Evaluate how nephrologists and biologists feel about using the new test in clinical practice.
Questionnaires specific to each sub-populations (nephrologists and biologists) using open-ended questions and Likert scale-coded responses.
Measured: 6th year
Assess the cost-effectiveness of the intervention compared to standard care at 36 months from the French Health care System perspective
Cost-effectiveness ratio (ICER) is defined as the difference in cost between the intervention and the standard care, divided by the difference in their effect (QALY).
Measured: through study completion, an average of 6 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2025
- Study start23 Apr 2025
- Primary completion1 May 2028 (estimated)
- Study completion2 Feb 2031 (estimated)
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 InfectionStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, interventional, multicentric, open-label, parallel group, superiority randomized controlled trial. Kidney transplant recipients from the 4 enrollment centers will be randomly assigned with a 1:1 allocation into experimental and control groups between 12- and 48-months post-transplantation, and prospectively followed for 36 months for the occurrence of a complication due to inadequate (over or under) immunosuppression.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06829719
- Sponsor's protocol ID
- 69HCL23_0834
- Acronym
- TAOIST
- Status last verified
- May 2026
- First submitted
- 3 Feb 2025
- Last updated
- 27 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Doberer K, Kapps S, Haupenthal F, Bond G. Immune Monitoring Goes Viral - Torque Teno Virus for Immunologic Risk Stratification After Kidney Transplantation. Transpl Int. 2025 Nov 14;38:15074. doi: 10.3389/ti.2025.15074. eCollection 2025.
PubMed 41323957
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalization of Maintenance Immunosuppression Based on TTV Viral Load to Prevent Long-term Complications in Renal Transplantation
- ClinicalTrials.gov ID
- NCT06829719
- Acronym / sponsor ID
- TAOIST / 69HCL23_0834
- Conditions
- Infection, Cancer, Rejection, Kidney Transplantation
- Keywords
- TTV, Biomarker, immunosuppression, precision medicine, kidney transplantation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 23 Apr 2025 (actual)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 2 Feb 2031 (estimated)
- First posted
- 17 Feb 2025 (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.
Long-term outcomes in kidney transplantation remain a significant challenge, as complications such as donor-specific antibodies (DSA), antibody-mediated rejection, infections, and cancer increasingly threaten graft and patient survival over time. The development of non-invasive biomarkers to guide the management of therapeutic immunosuppression beyond the first year post-transplantation is therefore a crucial unmet need.
Torque Teno Virus (TTV), a non-pathogenic virus with a high prevalence worldwide, has emerged as a promising biomarker in this context. Its replication inversely reflects immune control by T cells, correlating with the depth of therapeutic immunosuppression. Additionally, its slow replication kinetics make TTV DNAemia a useful marker for evaluating patient adherence to immunosuppressive treatments.
The TAOIST study tests whether longitudinal monitoring of TTV DNAemia every six months, starting from the second year after transplantation, can guide the personalization of immunosuppressive therapy. The primary endpoint is the time to the first occurrence of complications linked to inadequate immunosuppression, including dnDSA, biopsy-proven rejection, infection, cancer, or graft loss. Secondary objectives include evaluating the acceptability of TTV DNAemia among healthcare professionals and assessing its cost-effectiveness compared to standard care. An ancillary objective examines the link between TTV DNAemia and the immunosuppressant possession ratio (IPR) to explore its potential as a marker of treatment adherence.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, interventional, multicentric, open-label, parallel group, superiority randomized controlled trial. Kidney transplant recipients from the 4 enrollment centers will be randomly assigned with a 1:1 allocation into experimental and control groups between 12- and 48-months post-transplantation, and prospectively followed for 36 months for the occurrence of a complication due to inadequate (over or under) immunosuppression.
| Arm | Type | Receives |
|---|---|---|
| TTV-guided immunosuppression | Experimental | Biological: TTV DNAemia, Other: EQ-5D-5L questionnaire, Biological: Biological testsThe adaptation of the dose of maintenance immunosuppressive drugs will be based on TTV DNAemia measured on site in the plasma of patients every 6 months (at distance of an infection or a vaccination). The physicians will be free to change the dose of calcineurin inhibitors (CNI) and/or the mycophenolate mofetil (MMF) to maintain TTV DNAemia between 3.8 and 5.1 log10 cp/mL as long as the trough levels remain between 3-12 ng/mL for tacrolimus (50-250 ng/mL for cyclosporin) and the daily dose of MMF is comprise between 250 and 1500 mg bid for Cellcept (180 and 900 mg for Myfortic). |
| Standard Immunosuppression | Other | Biological: TTV DNAemia, Other: EQ-5D-5L questionnaire, Biological: Biological testsTTV DNAemia will also be measured every 6 months but the results will not be communicated to the physicians. Instead, the adaptation of the dose of maintenance immunosuppressive drugs will be performed according to the current standard of care: i) the dose of the CNI will be adapted to maintain the trough levels, monitored in the circulation every 3 month, between 5-10 ng/mL for tacrolimus (75-150 ng/mL for cyclosporin) and ii) the dose of MMF will be adjusted to maintain the AUC, measured every year, between 30-60 h.mg/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult ≥ 18 years-old
- Recipient of a kidney allograft (third graft at most)
- 12 to 48 months post-transplantation
- Stable graft function (defined as: delta creatininemia over the previous 6 months < 20% and proteinuria < 30mg/mmol)
- On maintenance immunosuppression, which includes CNI (cyclosporin or tacrolimus) and MMF (Cellcept or Myfortic) with or without corticosteroids
Key exclusion criteria (10 listed)
- Recipient of an HLA identical graft
- Mutiple organ transplantation or functional transplant other than kidney
- Maintenance immunosuppression that includes a mTOR inhibitor, belatacept or imurel
- Presence of histological sign of active rejection (i+t > 2 and g+cpt > 2) on graft biopsy performed within 3 months before enrollment
- Uncontrolled infection at inclusion
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 |
|---|---|---|
| TTV DNAemiaEvery 6 months, one sample added at the same time (7mL) of a routine laboratory analysis for TTV DNAemia | Biological | Standard Immunosuppression, TTV-guided immunosuppression |
| EQ-5D-5L questionnaireCompleted every 6 months and each time a complication of interest occurs | Other | Standard Immunosuppression, TTV-guided immunosuppression |
| Biological testsBiological tests as routine care procedure (creatinine, CNI pre-dose trough level) will be performed every 6 months | Biological | Standard Immunosuppression, TTV-guided immunosuppression |
Primary outcome
Compare the time from randomization to first complication of inadequate immunosuppression between the experimental group, whose treatment is tailored on quarterly TTV viral load results, and the control group.
Time frame: through study completion, an average of 6 years
Time from randomization to occurrence of the first complication of inadequate immunosuppression: development of dnDSA, biopsy-proven rejection, infection, cancer, graft loss. Patients lost to follow-up or died without an event before will be right censored at this date.
8 secondary outcomes
Proportion of patients with at least one complication of inadequate immunosuppression between the experimental and control groups at 36 months
Time frame: through study completion, an average of 6 years
Compare the rate of complications of inadequate immunosuppression between patients in the experimental and control groups.
Time frame: through study completion, an average of 6 years
Describe the nature and timing of various complications of inadequate immunosuppression in the experimental and control groups.
Time frame: through study completion, an average of 6 years
Compare the proportion of patients with adequate immunosuppressive therapy between the experimental and control groups.
Time frame: through study completion, an average of 6 years
Compare the proportion of quarterly systematic checks of TTV DNAemia in the target between patients in the experimental and control groups.
Time frame: Every 6 months
Model the impact of variations in dose and residual rates (pre-dose trough levels or AUC) of the various immunosuppressive drugs on TTV viral load.
Time frame: every 6 months
Evaluate how nephrologists and biologists feel about using the new test in clinical practice.
Time frame: 6th year
Assess the cost-effectiveness of the intervention compared to standard care at 36 months from the French Health care System perspective
Time frame: through study completion, an average of 6 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2026.
- Derived from this study: PubMed 41323957Doberer K, Kapps S, Haupenthal F, Bond G. Immune Monitoring Goes Viral - Torque Teno Virus for Immunologic Risk Stratification After Kidney Transplantation. Transpl Int. 2025 Nov 14;38:15074. doi: 10.3389/ti.2025.15074. eCollection 2025.
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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.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TTV DNAemia, EQ-5D-5L questionnaire and Biological tests in people with Infection and Cancer, run by Hospices Civils de Lyon at 4 sites in France.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 27 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olivier THAUNAT, Professor MD, PhD (+334.72.11.69.28, olivier.thaunat@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the time from randomization to first complication of inadequate immunosuppression between the experimental group, whose treatment is tailored on quarterly TTV viral load results, and the control group. (time frame: through study completion, an average of 6 years). 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 NCT06829719, 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 27 May 2026.