kidney transplantation/ niertransplantatie rejection/ rejectie immunologic profiling/ immunologisch risico tacrolimus advagraf infectious compications/ infectieuze complicaties
Conditions
Interventions
Participants are converted from Prograft to Advagraf one week after kidney transplantation. Six months after transplantation participants with stable renal function (eGFR >30 ml/min and proteinuria &#
0.5 gram per 10 mmol creatinin in spot urine) are randomized to either continue standard therapy with Advagraf and Cellcept or gradually decrease the Cellcept, to Advagraf monotherapy at 9 months. A r
Sponsors
Erasmus Medical Center, Rotterdam, The Netherlands
Eligibility
Inclusion criteria
Inclusion criteria: - Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and: - Historical PRA 30 in mL/min with proteinuria ≤0.5 gram per 10 mmol creatinin in spot urine.
Exclusion criteria
Exclusion criteria: - HLA identical living-related transplant recipients. - Patients with an indication to continue MMF or other immunosuppressive drugs, e.g. vasculitis, SLE etc. (according to judgement of treating physician). - Recipient of an ABO-incompatible allograft or with a positive crossmatch (complement-dependent cytotoxicity or flow cytometry). - Biopsy proven rejection three months and later after transplantation. - Recipient of multiple organ transplants. - Females of childbearing potential who are planning to become pregnant, who are pregnant and/or lactating or who are unwilling to use effective means of contraception. - T-cell depleting therapy (anti-thymocyte globulin and alemtuzumab) after transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility objectives are consent rate, BPAR-rate and biological plausibility. The primary objective of the pilot study consists of the following immunological markers: I.Number of cytokine-producing alloreactive CD137+ T cells. II.Total number of infectious episodes. III.Vaccination response score. Eight secondary objectives are described in the protocol. Criteria for success of pilot study: 1.A total of 100 patients is recruited within three years. 2.Consent is given in 70% of eligible patients. 3.The descriptive outcomes in general immune responses provide for a biological plausible benefit of TACmono over dual therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. BPAR rate 15 months after kidney transplantation. 2. Assessment of de novo (complement-fixating) alloantibody formation as detected by Luminex. 3. Kidney allograft function (eGFR with MDRD formula and proteinuria expressed in urine protein/creatinine ratio). 4. Detection of donor-specific CD137+ T cells. 5. Composition of leucocyte subsets. 6. Blood pressure levels and number of antihypertensive drugs after discontinuation of MMF as compared to continuation with dual TAC/MMF therapy. 7. Histological findings in renal transplant biopsy at time of randomisation (6 months) and its correlation with BPAR-rate 15 months after transplantation. 8. Gastrointestinal symptom score and quality of life outcomes. | — |
Contacts
Public ContactA.E. Weerd, de
Internist-nephrologist Erasmus Medical Center Room D-411 Postbus 2040
Outcome results
None listed