Immune Tolerance Network   

A clinical research consortium sponsored by NIAID

What is RESTARRT?

Father and son at the beach smiling.The RESTARRT Study

RESTARRT is a clinical research study that is testing whether a combination of several medications can reset your immune system and help it accept your new kidney without the need for life-long immunosuppression.

The medications used in RESTARRT: anti-thymocyte globulin (ATG), rituximab, mycophenolate mofetil (MMF), tacrolimus and sirolimus are not new. ATG is used to treat transplant rejection and rituximab is an approved treatment for some blood cancers, rheumatoid arthritis and a rare type of blood vessel inflmamatiion. MMF, sirolimus and tacrolimus are immunosuppressant drugs used to prevent rejection in organ transplantation. Because they have not been used together to prevent transplant rejection, this combination is considered experimental.

Participants in the RESTARRT study will receive these medications before, during, and after their transplant. Standard immunosuppressive drugs will initially be prescribed. Eligible participants will be asked to undergo a gradual reduction of their immunosuppressive medication with the goal of stopping these drugs permanently. This will be done under the close supervision of the RESTARRT transplant team.