CTIS2022-500024-30-00
Recruiting
Phase 1
A non-inferiority, randomised and controlled trial to compare the safety, tolerability and preliminary efficacy between standard and Torque Teno virus-guided immunosuppression in stable adult kidney transplant recipients with low immunological risk in the first year after transplantation - TTV GUIDE IT
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Post Kidney transplantation
- Sponsor
- Medical University Of Vienna
- Enrollment
- 260
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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