The ONE Study: A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation – Reference Group Trial

Conditions: Kidney allograft rejection following living-donor renal transplantation.
MedDRA version: 14.1Level: LLTClassification code 10051366Term: Kidney graft dysfunctionSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10049581Term: Graft rejection episodeSystem Organ Class: 100000004870
MedDRA version: 14.1Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865
MedDRA version: 14.1Level: LLTClassification code 10069030Term: Graft failureSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10038297Term: Rejection acute renalSystem Organ Class: 100000004870
MedDRA version: 14.1Level: LLTClassification code 10021510Term: Immunosuppression NOSSystem Organ Class: 100000004870
MedDRA version: 14.1Level: LLTClassification code 10038299Term: Rejection chronic renalSystem Organ Class: 100000004863
MedDRA version: 14.1Level: LLTClassification code 10066543Term: Acute allograft rejectionSystem Organ Class: 100000004870
Therapeutic area: Body processes [G] - Immune system processes [G12]

Registration Number: EUCTR2011-004301-24-DE

Lead Sponsor: Free State of Bavaria, represented by the University of Regensburg, represented by Prof. Edward K. Geissler

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 60

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

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.