Kidney allograft rejection following living-donor renal transplantation. MedDRA version: 17.0 Level: LLT Classification code 10051366 Term: Kidney graft dysfunction System Organ Class: 100000004863 MedDRA version: 17.0 Level: LLT Classification code 10049581 Term: Graft rejection episode System Organ Class: 100000004870
Conditions
Interventions
Product Name: Mreg_UKR
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: Not available (see D.3.9.3)
Other descriptive name: M REG
Sponsors
University Hospital Regensburg
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 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 16
Exclusion criteria
Exclusion criteria: The main exclusion criteria for trial patients (organ recipients) are: • Patient has previously received any tissue or organ transplant other than the planned kidney graft • Known contraindication to the protocol-specified treatments / medications • 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 • CMV-negative and receiving a kidney from a CMV-positive donor • Significant liver disease (persistently elevated AST and/or ALT levels > 2 x ULN) • Malignant or pre-malignant haematological conditions • Known IgA or IgG deficiency • Any pro-coagulant disposition, as evidenced by a past history of thromboembolic disease or abnormal laboratory coagulation parameters which, in the judgement of the Investigator, would place the subject at undue risk • Previous history of transfusion-associated disease which, in the judgement of the Investigator, would place the subject at undue risk • Any condition resulting in a substantial reduction in the volume of the pulmonary vasculature or an increase in the pulmonary vascular resistance. Any disease or disease process leading to substantially elevated pulmonary arterial pressure (as evidenced by electrocardiography, echocardiography, radiology or cardiac catheterisation) or right heart hypertrophy or dysfunction • Known atrial or ventricular septal defects posing a risk of paradoxical embolism of infused cells or cell aggregates • Known hypersensitivity to any component of the cell product or components used in the manufacture of the cell product.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect further evidence of the safety of administering donor-derived M reg preparations to living-donor renal transplant recipients. In addition, the study will determine whether pre-transplant M reg infusion allows some degree of tapering of conventional maintenance immunosuppression within 60 weeks after transplantation.; Secondary Objective: To measure various clinical, immunological and health-economic parameters for comparison against reference ranges previously generated in the preceding ONE Study Reference Group Trial (ONErgt11; EudraCT number: 2011-004301-24). 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 to screen patients for evidence of harm or benefit caused by administering the Mreg_UKR cell product. A Health-Economics Subproject will collect patient-reported outcomes using quality-of-life questionnaires and record healthcare resource use data to assess the total cost of the protocol treatment and gauge the health-economic impact of M reg therapy in ONEmreg12. ;Primary end point(s): The primary endpoint is the incidence of biopsy-confirmed acute rejection (BCAR).;Timepoint(s) of evaluation of this end point: Incidences of BCAR occurring within 60 weeks following kidney transplantation will be evaluated in the final analysis. | — |
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 patients treated for subclinical acute rejection • Incidence of chronic graft dysfunction • Incidence of graft loss through rejection (acute/chronic) • Incidence of adverse drug reactions • Incidence of acute toxicities associated with infusion of the cell product • Incidence of major and/or opportunistic 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
Germany
Contacts
Public ContactClinical Study Centre Surgery
University Hospital Regensburg
Outcome results
None listed