kidney transplantation
Conditions
Interventions
Trade Name: Advagraf
Product Name: Advagraf
Pharmaceutical Form: Tablet
Trade Name: CellCept
Product Name: CellCept
Pharmaceutical Form: Tablet
Sponsors
Erasmus Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 30
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: - 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 |
|---|---|
| Timepoint(s) of evaluation of this end point: Follow-up will be 15 months after transplantation.;Main Objective: Feasibility objectives: 1. Methodology: Outcome in the control group: what is the BPAR-rate in the control group? 2. Process: Consent rates. How many patients can be included, what is the rate of consent, determining centre willingness and capacity? 3. Scientific (biological plausibility): The primary objective of the pilot study is to estimate the treatment effect using surrogate endpoints with the following immunological parameters: I. Detection of total alloreactive T-cell compartment by CD137+ T staining. II. Leucocyte subsets. III. In vivo assessment of general immune responses: - Vaccination responses: Tetanus, pneumococcus, influenza. IV. The incidence of infection as measured by: a. detection of polyoma BK viral load in serum. b. detection of CMV viral load in serum. c. hospital admission for infection-related problems. d. antibiotic prescriptions (treatment episode defined as 5 or more consecutive days of antibiotic treatment). ;Secondary Objective: 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 CKD-EPI formula and proteinuria expressed in urine protein/creatinine ratio). 4. Detection of donor-specific CD137+ T cells. 5. Blood pressure levels and number of antihypertensive drugs after discontinuation of MMF as compared to continuation with dual TAC/MMF therapy. 6. Gastrointestinal symptom score and quality of life outcomes. Criteria for success of pilot study: 1. A total of 120 patients is recruited within four 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.;Primary end point(s): This pilot study is an exploratory, randomized-controlled trial. The primary endpoint of | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary study parameters/endpoints The secondary study parameters will be: - BPAR rate 15 months after kidney transplantation - presence of complement-fixating alloantibodies. - renal allograft function (eGFR with MDRD formula and proteinuria expressed in urine protein/creatinine ratio). - number of donor-specific CD137+ T cells - blood pressure levels and number of antihypertensive drugs after discontinuation of MMF versus controls - gastrointestinal symptom score and adherence. ;Timepoint(s) of evaluation of this end point: Follow-up will be 15 months after transplantation. | — |
Countries
Netherlands
Contacts
Public ContactA. (Annelies) E. de Weerd
Erasmus Medical Center
Outcome results
None listed