TAR:GET-1
Research type
Research Study
Full title
A multicentre randomised controlled trial to assess the efficacy of adding rituximab to standard of care in treating acute antibody-mediated rejection in kidney transplantation (Transplant Antibody-mediated Rejection: Guiding Effective Treatments-1 (TAR:GET-1))
IRAS ID
201748
Contact name
Michelle Willicombe
Contact email
Sponsor organisation
Imperial College London
Eudract number
2018-002882-20
ISRCTN Number
ISRCTN18179652
Clinicaltrials.gov Identifier
Duration of Study in the UK
7 years, 10 months, 1 days
Research summary
Chronic antibody-mediated rejection (cAMR) is the leading cause of kidney transplant failure. Fifty percent of kidney transplant patients who develop acute antibody-mediated rejection (aAMR) will develop evidence of cAMR within 1 year of the acute rejection episode. There is currently no evidence on how to treat aAMR.
The planned research is a randomised controlled trial, which compares an acceptable and commonly used therapy, which will be referred to as "standard of care", with an additional agent, rituximab, added to the "standard of care" treatment. The participants with be randomised in a 1:1 ratio.
"Standard of care" will include optimisation of the participant's baseline anti-rejection medications and therapy to remove the antibodies which have developed against the kidney transplant, which are causing the damage. This is called plasma exchange. The participants will also receive therapy to reduce inflammation and reduce their immune response to their kidney transplant. This will be achieved using corticosteroids and intravenous immunoglobulins, respectively. These therapies have been used to treat aAMR for many decades.
The intervention arm will consist of the "standard of care" treatment, with the addition of a drug called rituximab, which will be administered in 2 separate doses. Rituximab is itself an antibody, which binds to certain cells in the body involved in antibody production, called B cells. Following the administration of rituximab, the number of B cells is reduced, which affects antibody production. Rituximab is commonly used in transplantation for this indication, as well as for other conditions.
Participants in both arms will be followed up to determine if there is a difference in the time to transplant failure and/or transplant function.REC name
London - West London & GTAC Research Ethics Committee
REC reference
19/LO/0180
Date of REC Opinion
17 Apr 2019
REC opinion
Further Information Favourable Opinion