A randomised controlled trial of regulatory immune cells (Tregs) to allow reduction of immunosuppression following renal transplantation.

Phase 1

• Conditions: Renal (allograft) transplant; MedDRA version: 20.0Level: LLTClassification code 10050436Term: Prophylaxis against renal transplant rejectionSystem Organ Class: 100000004865; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2017-001421-41-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-11
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

Kidney Donor:-
- aged at least 18
- ABO blood group compatible with the recipient
- eligible for live kidney donation
- willing and able to give informed consent for participation in the trial

Kidney Recipient
- Chronic renal insufficiency necessitating kidney transplantation and approved to receive a primary kidney allograft from a living donor
- Willing and able to give informed consent for participation in the trial
- Aged over 18 years

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 28

Exclusion Criteria

Kidney Donor
- Participation in another interventional clinical trial during the study or within 28 days prior to planned study entry
- Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated personnel

Kidney Recipient

•The potential participant has previously received any other type of tissue or organ transplant
•Known contraindication to the protocol-specified treatments or medications
•ABO blood group incompatible with donor
•Calculated reaction frequency (CRF) of >40% within 6 months prior to transplant
•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 or squamous cell carcinomas of the skin)
•Serologically positive for anti-HIV-1/2 Ab, HbsAg, anti-HBcAb, antiHCV Ab, anti-HTLV-1/2 Ab or syphilis (treponema palladium)
•Significant liver disease, defined as persistently elevated ALT levels >3 x upper limit of normal range (ULN)
•Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
•Participation in another interventional clinical trial during the study or within 28 days prior to planned study entry
•Female participant who is pregnant, lactating or planning pregnancy during the course of the trial
•Psychological, familial, sociological, or geographical factors potentially hampering compliance with the study protocol and follow-up visit schedule
•Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the investigator, may invalidate communication with the investigator and/or designated personnel

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified