Abstract
Background: Immunosuppression in transplantation continues to be associated with a multitude of adverse effects. Induction of immune tolerance may be a viable strategy to reduce dependence on immunosuppression. Various trials are currently underway to assess the efficacy of this strategy. However, long-term safety data for these immune tolerance regimes has yet to be established. Methods/design: At the completion of primary follow-up of various Medeor kidney transplant studies, subjects receiving cellular immunotherapy products will be followed annually as per protocolized schedule for up to an additional 84 months (7 years) to evaluate long-term safety. Long-term safety will be assessed by summarizing incidence of serious adverse events, adverse events leading to study withdrawal and hospitalization rates. Discussion: This extension study will be an important step in evaluating safety issues pertaining to immune tolerance regimens, long-term effects of which are largely unknown. These data are essential for furthering an unrealized goal of kidney transplantation- graft longevity without the adverse effects from long-term immunosuppression. The study design utilizes the methodology of a master protocol, wherein multiple therapies can be assessed simultaneously with accompanied gathering of long-term safety data.
Original language | English (US) |
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Article number | 178 |
Journal | Trials |
Volume | 24 |
Issue number | 1 |
DOIs | |
State | Published - Dec 2023 |
Keywords
- Immunosuppression
- Immunotherapy
- Kidney transplantation
- Tolerance
ASJC Scopus subject areas
- Pharmacology (medical)
- Medicine (miscellaneous)