kidney transplant patients
Conditions
Interventions
Pharmaceutical Form: Capsule
INN or Proposed INN: TACROLIMUS
CAS Number: 104987-11-3
Current Sponsor code: Tacrolimus
Other descriptive name: Tacrolimus
Concentration unit: mg milligram(s)
Concentrati
Sponsors
Charité - Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women, age =18 years. 2) Subject must be a recipient of a first renal transplant from a deceased or living donor. 3) Subject must have a current documented PRA 35 mIU/mL]. WOCBP must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of clinical trial. 6) Sexually active (including vasectomised) men taking mycophenolate are willing to use condoms for sex during MMF treatment and for 90 days thereafter; partners of childbearing potential have to use highly effective contraception for the same period. 7) Subjects are willing not to donate blood during and for 6 weeks after MMF treatment, and men could not donate sperm during MMF treatment and for 90 days after stopping MMF treatment. 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 447 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 222
Exclusion criteria
Exclusion criteria: 1) Subjects undergoing renal transplant with a current documented PRA >20% and/or detectable anti-class I and II HLA antibodies by solid phase assay (Luminex®). 2) CDC positive cross match. 3) Subjects receiving an allograft from a donor older than 65 years with elevated creatinine levels and/or treated diabetes. 4) Cold ischemia time (CIT) higher than 24h. 5) Subjects with a prior solid organ transplant (SOT), including renal re-transplantation, or receiving a concurrent SOT. 6) Patients previously treated with daclizumab or basiliximab. 7) Subjects with underlying renal disease of: a. Primary focal segmental glomerulosclerosis. b. Type I or II membranoproliferative glomerulonephritis c. Atypical Haemolytic uremic syndrome (HUS) / thrombotic thrombocytopenic purpura syndrome. 8) Subject with Hepatitis B chronic infection and/or active infection by Hepatitis C virus (positive PCR result) at the moment of transplant. 9) Subjects with known human immunodeficiency virus (HIV) infection. 10) Patients with active systemic infection that requires the continued use of antibiotics. 11) Patients with neoplasia except localized skin cancer receiving appropriate treatment. 12) Patients with severe anemia (hemoglobin 6 g/dl. 14) Patients with intestinal pathology or severe diarrhoea that can hinder absorption according to medical criteria. 15) Subjects with a known hyper sensibility to any of the drugs used in this protocol. 16) Subjects who have used any investigational drug within 30 days prior to enrolment in this clinical trial. 17) WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period, women who are pregnant or breastfeeding or women with a positive pregnancy test on enrolment. 18) Subjects who are legally detained in an official institution
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the study is to demonstrate the utility and safety of the IFN-? ELISPOT marker for the stratification of kidney transplant recipients into low and high IS regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 15%.;Secondary Objective: - To investigate differences across treatment arms in the following secondary outcomes: e.g. eGFR (ml/min) at 6 and 12 months etc. - Health economics, H-R QoL and treatment cost (cost/benefit) at 1, 3, 6, 12 and 24 months.;Primary end point(s): The main objective of the study is to demonstrate the utility and safety of the IFN-? ELISPOT marker for the stratification of kidney transplant recipients into low and high IS regimens. The enrichment study will test non-inferiority of low IS regimen compared to high IS regimen, assuming 10% of BPAR at 6-months in the control group, and allowing a non-inferiority limit of maximum 15%.;Timepoint(s) of evaluation of this end point: 12 months post-transplantation | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To investigate differences across treatment arms in the following secondary outcomes: - eGFR (ml/min) assessed by the CKD-EPI formula at 6 and 12 months - Prevalence of biomarkers* of tolerance/hyporesponsiveness at 3 and 12 months. - Incidence, type, severity, treatment, and outcome of BPAR by 6 and 12 months after transplantation. - Prevalence, type, severity, treatment, and outcome of subclinical rejection by 6 and 12 months after transplantation. - Prevalence of death, and graft loss by 6 and 12 months. - Prevalence of metabolic and cardiovascular co-morbidity (new onset diabetes mellitus (NODAT), dyslipidemias, hypertension) by 12 months. - Prevalence of subjects that remain MMF and steroid-free at 6 and 12 months after transplantation - Prevalence of Acute and chronic histologic lesions assessed by the Bannf’11 score in protocol biopsies at months 3 and 12 post-transplantation. - Prevalence of patients that remain on Therapy at 12 months after transplantation. - Distribution of patients in distinct chronic kidney diseases (CKD) stages by 12 months. - Health economics, H-R QoL and treatment cost (cost/benefit) at 1, 3, 6, 12 and 24 months.;Timepoint(s) of evaluation of this end point: - eGFR (ml/min) assessed by the CKD-EPI formula at 6 and 12 months - Prevalence of biomarkers* of tolerance/hyporesponsiveness at 3 and 12 months. - Incidence, type, severity, treatment, and outcome of BPAR by 6 and 12 months after transplantation. - Prevalence, type, severity, treatment, and outcome of subclinical rejection by 6 and 12 months after transplantation. - Prevalence of death, and graft loss by 6 and 12 months. | — |
Countries
Czech Republic, Germany, Netherlands, Spain
Contacts
Public ContactProject manager
Charité - Universitätsmedizin Berlin
Outcome results
None listed