immuneresponse renal transplantation
Conditions
Interventions
alloresponse
kidney
minimalization of medication
transplantation
Sponsors
Charite Universiteitskliniek Berlijn
Eligibility
Age
18 Years to 64 Years
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The main objective of the study is to demonstrate the utility and safety of the IFN-γ 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
| Measure | Time frame |
|---|---|
| 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 posttransplantation. - 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. E.5.2.1 | — |
Countries
Czechia, France, Germany, Netherlands, Spain, United Kingdom
Outcome results
None listed