Kidney allograft rejection following living-donor renal transplantation. MedDRA version: 14.1 Level: LLT Classification code 10051366 Term: Kidney graft dysfunction System Organ Class: 100000004863 MedDRA version: 14.1 Level: LLT Classification code 10049581 Term: Graft rejection episode System Organ Class: 100000004870 MedDRA version: 14.1 Level: LLT Classification code 10050436 Term: Prophylaxis against renal transplant rejection System Organ Class: 100000004865 MedDRA version: 14.1 Level:
Conditions
Interventions
Trade Name: Simulect
Pharmaceutical Form: Powder and solvent for solution for injection/infusion
INN or Proposed INN: Basiliximab
CAS Number: 179045-86-4
Other descriptive name: BASILIXIMAB
Concentrat
Sponsors
Free State of Bavaria, represented by the University of Regensburg, represented by Prof. Edward K. Geissler
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: The main inclusion criteria for trial patients (organ recipients) are: • Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor • Aged at least 18 years • Signed and dated written informed consent. 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 60 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: The main exclusion criteria for trial patients (organ recipients) are: • Patient has previously received, or is scheduled to receive, any tissue or organ transplant other than the planned kidney graft • Known sensitivity to tacrolimus, mycophenolate or corticosteroids • Genetically identical to the prospective organ donor at the HLA loci • PRA grade > 40% within 6 months prior to enrolment • Previous treatment with any desensitisation procedure (with or without IVIg) • Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully-treated non-metastatic basal/squamous cell carcinoma of the skin) • Evidence of significant local or systemic infection • HIV-positive, EBV-negative or suffering chronic viral hepatitis • Significant liver disease (persistently elevated AST and/or ALT levels > 2 x ULN) • Malignant or pre-malignant haematological conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): The primary endpoint is the incidence of biopsy-confirmed acute rejection (BCAR).;Main Objective: To confirm the rate of acute kidney graft rejection in the study population under standard immunosuppressive therapy in order to corroborate historical renal transplantation statistics and generate reference ranges for future clinical research within The ONE Study. The Reference Group Trial is the first clinical trial planned within the context of The ONE Study, an international, non-commercial research project that ultimately aims in subsequent trials to test several alternative GMP cell products as adjunct immunosuppressive treatments in kidney transplantation. Future trials will assess whether immunoregulatory cell infusion could allow for a reduction in the use of pharmacological maintenance therapy in transplant recipients and alleviate the drawbacks associated with traditional immunosuppressive agents.;Secondary Objective: The Reference Group Trial will also measure various clinical, immunological and health-economic parameters to generate reference ranges for future cell therapy studies within The ONE Study project. An Immune Monitoring Subproject will use scientific laboratory assays to investigate the progression of the immunological response in trial patients by measuring functional and molecular correlates of immune reactivity. Results will be used as a reference data set to screen patients for evidence of harm or benefit caused by administering cell products in future ONE Study cell therapy trials. A Health-Economics Subproject will collect patient-reported outcomes using quality-of-life questionnaires and record healthcare resource use data to assess the costs of standard immunosuppressive treatment. These reference results will be used to gauge the health-economic impact of alternative cell products in the future ONE Study cell therapy trials.;Timepoint(s) of evaluation of this end point: Incidences of BCAR occurring within 60 week | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary endpoints include: • Time to first acute rejection episode • Severity of acute rejection episodes (based on response to treatment and histological scoring) • Total immunosuppressive burden at 60 weeks post-transplantation • Incidence of chronic graft dysfunction • Incidence of graft loss through rejection (acute/chronic) • Incidence of adverse drug reactions • Incidence of major infections • Incidence of neoplasia.;Timepoint(s) of evaluation of this end point: Secondary endpoints occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis. | — |
Countries
France, Germany, Italy, United Kingdom, United States
Contacts
Public ContactClinical Study Center Surgery
University Hospital Regensburg
Outcome results
None listed