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New treatment option for Infection
Official title TTV-based mAnagement Of Long-term ImmunosuppreSsion in Kidney Transplantation
ClinicalTrials.gov ID: NCT06829719
What this study is testing
What is TTV DNAemia?
TTV DNAemia is an investigational medicine, being studied as a potential treatment for infection.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
See the full eligibility criteria
- 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
- No circulating DSA in solid phase assay
- Undetectable BKV DNAemia at enrollment
- Written informed consent
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Bordeaux (France), France
- Lyon, France
- Strasbourg (france), France
- Toulouse (France), France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bordeaux (France), France; Lyon, France; Strasbourg (france), France; Toulouse (France), France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.