Tacrolimus monotherapy in low-risk kidney transplant recipients.
Recruiting
- Conditions
- kidney transplantation/ niertransplantatierejection/ rejectieimmunologic profiling/ immunologisch risicotacrolimusadvagrafinfectious compications/ infectieuze complicaties
- Registration Number
- NL-OMON26543
- Lead Sponsor
- Erasmus Medical Center, Rotterdam, The Netherlands
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Adult patients receiving a deceased or living kidney transplant in the Erasmus Medical Center Rotterdam, The Netherlands and:
-Historical PRA <5% and
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).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Feasibility objectives are consent rate, BPAR-rate and biological plausibility. <br /><br>The primary objective of the pilot study consists of the following immunological markers:<br /><br>I.Number of cytokine-producing alloreactive CD137+ T cells. <br /><br>II.Total number of infectious episodes.<br /><br>III.Vaccination response score.<br /><br>Eight secondary objectives are described in the protocol.<br /><br>Criteria for success of pilot study:<br /><br>1.A total of 100 patients is recruited within three years.<br /><br>2.Consent is given in 70% of eligible patients.<br /><br>3.The descriptive outcomes in general immune responses provide for a biological plausible benefit of TACmono over dual therapy.<br>
- Secondary Outcome Measures
Name Time Method 1.BPAR rate 15 months after kidney transplantation.<br /><br>2.Assessment of de novo (complement-fixating) alloantibody formation as detected by Luminex.<br /><br>3.Kidney allograft function (eGFR with MDRD formula and proteinuria expressed in urine protein/creatinine ratio).<br /><br>4.Detection of donor-specific CD137+ T cells.<br /><br>5.Composition of leucocyte subsets.<br /><br>6.Blood pressure levels and number of antihypertensive drugs after discontinuation of MMF as compared to continuation with dual TAC/MMF therapy. <br /><br>7.Histological findings in renal transplant biopsy at time of randomisation (6 months) and its correlation with BPAR-rate 15 months after transplantation.<br /><br>8.Gastrointestinal symptom score and quality of life outcomes.<br>