RESTARRT: Immunosuppression with Anti-thymocyte Globuline, Rituximab, Tacrolimus, and Sirolimus, Followed by Withdrawal of Tacrolimus and Sirolimus, in Living-donor Renal Transplant Recipients

Study Status

Open to Enrollment

Study Description

If you are considering a kidney transplant...

One of the most important parts of a successful kideny transplant takes place after the surgery--the choice and use of anti-rejection medications. These medications must be taken for life, and as time goes on, they risk harming your new kidney and other organs.

RESTARRT is a clinical trial testing whether a unique combination of two drugs will allow kidney transplant recipients to reduce or completely stop taking anti-rejection medications long term.

The medications used in RESTARRT--ATG and rituximab--are not new. ATG is currently used to treat transplant rejection and rituximab is an approved treatment for rheumatoid arthritis. Because they have not been used together to prevent transplant rejection in people before, this is considered an expirimental treatment.

Subjects participating in the RESTARRT study will receive these medications around the time of their transplant. Standard oral immunosuppressive drugs will be prescribed for one year. Then, eligibile participants will be asked to begin slowly and methodically reducing their anti-rejection medication. This will be done under the close supervision of the transplant team.

As a participant in RESTARRT, you will receive:

  • all study medications at no cost to you
  • regular and frequent monitoring of your health and the health of your transplanted kidney by our team of transplant experts
  • the opportunity to gradually reduce immunosuppression levels under close medical supervision

Participation may last up to four years.

Disease Status and/or Stage

Renal Transplant Recipients

Sponsor

NIAID; Immune Tolerance Network (ITN)

Key Eligibility

  • If you are between the ages of 18 to 65 years old and planning to receive a first kidney transplant from a living-related donor you may be eligibile to participate in RESTARRT
  • Contact us at the number below for more information on the study and to help you decide whether participating in RESTARRT is the right decision for you

Principal Investigator

Choli Hartono, MD

Contact

Healthy Volunteers

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Contact Us

For general inquiries, or if you need assistance finding a study, please contact:

Robert Hagerty
Subject Recruitment Manager
Tel: (646) 962-9340
[email protected]

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