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Personalized dosing of immunosuppression after kidney transplantation by measuring the immune system functionality
EU CTIS ID: 2022-500024-30-00
What this study is testing
To demonstrate non-inferiority with respect to safety, tolerability and preliminary efficacy of TTV-guided immunosuppression compared to standard TAC dosing in stable adult kidney transplant patients with low immunological risk in the first year after transplantation.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Recipient of a kidney allograft
- Adult (≥18 years of age)
- Post day 93 following transplantation
- TAC-based immunosuppression
- Standard target TAC trough level (as defined by local centre; might exclude patients with e.g. a lung transplantation or de novo DSA or thrombotic microangiopathy [TMA] if the centre applies non-standard TAC trough levels in these circumstances)
- Written informed consent
You likely can't join if
- HLA incompatible transplantation (as defined by local centre; e.g. preformed DSA and/or crossmatch conversion)
- Women of childbearing potential, except women who meet one of the following criteria: a) post-menopausal (12 months natural amenorrhoea) b) postoperative (6 weeks after bilateral ovarectomy with or with- out hysterectomy, bilateral salpingectomy) c) regular and correct use of a contraceptive method with an Pearl Index < 1% per year d) sexual abstinence e) vasectomy of the partner
- Treatment with T-cell depleting drugs within 2 months before the randomization (e.g. anti-thymocyte globulin)
- Unstable angina, cardiac decompensation with the necessity of inpatient treatment
- Current infection or allograft rejection as defined by the primary end-point
- Biopsy proven antibody mediated rejection (ABMR) or BK vi- rus PCR ≥104 c/ml (or corresponding U/mL) in the blood until randomisation.
See the full eligibility criteria
- Recipient of a kidney allograft
- Adult (≥18 years of age)
- Post day 93 following transplantation
- TAC-based immunosuppression
- Standard target TAC trough level (as defined by local centre; might exclude patients with e.g. a lung transplantation or de novo DSA or thrombotic microangiopathy [TMA] if the centre applies non-standard TAC trough levels in these circumstances)
- Written informed consent
- HLA incompatible transplantation (as defined by local centre; e.g. preformed DSA and/or crossmatch conversion)
- Women of childbearing potential, except women who meet one of the following criteria: a) post-menopausal (12 months natural amenorrhoea) b) postoperative (6 weeks after bilateral ovarectomy with or with- out hysterectomy, bilateral salpingectomy) c) regular and correct use of a contraceptive method with an Pearl Index < 1% per year d) sexual abstinence e) vasectomy of the partner
- Treatment with T-cell depleting drugs within 2 months before the randomization (e.g. anti-thymocyte globulin)
- Unstable angina, cardiac decompensation with the necessity of inpatient treatment
- Current infection or allograft rejection as defined by the primary end-point
- Biopsy proven antibody mediated rejection (ABMR) or BK vi- rus PCR ≥104 c/ml (or corresponding U/mL) in the blood until randomisation.
- Unstable graft function: eGFR <25 mL/min/1.73m2 (this limit might be ignored if creatinine clearance is >25 mL/min/1.73m2) or rapid and relevant eGFR decline (as defined by local centre), urinary protein/creatinine ratio >2000 mg/g, or rapid and rele- vant increase (as defined by the local centre)
- Advanced liver failure (CHILD-Pugh score C)
- History of malignancy other than squamous cell carcinoma or basal cell carcinoma of the skin or carcinoma in situ or ade- noma of the colon within the last 5 years unless in complete re- mission since at least 3 years
- Leukopenia <2000/mm3 or neutropenia <1000/mm3
- Severe tremor (as defined by local centre) due to TAC
- Combined transplantation
- ABO incompatible transplantation (as defined by local centre; e.g. relevant ABO incompatible blood group combination)
- Inability to perform study visits at the trial centre
- Any state that excludes adherence with the trial protocol, such as serious medical or psychiatric illness, language barrier, alcohol or illicit substance abuse or non-adherence
- Addictions or other illnesses that do not allow the person concerned to assess the nature and extent of the clinical trial and its possible consequences
- Simultaneous participation in another interventional clinical trial
- Pregnant or breastfeeding women
- History of HIV or active Hep B/C infection
- No standard immunosuppression according to local centre definition; e.g. necessity of significant additional long term im- munosuppression or immune modulation (e.g. disease modify- ing agents in autoimmune disease or immune modulators for cancer)
- Donor history of HIV or Hep B/C infection
- TTV load always below 4.6 log10 c/mL during screening phase
- No stable TAC trough levels achieved during screening phase (as defined by local centre)
- Hypersensitivity to TAC or other macrolides and hypersensitivity to any excipients
- Cyclosporine, mTor inhibitor or Co-stimulation blocker based immunosuppression.
The study team makes the final eligibility decision.
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, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.