Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE
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. Ho...
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| Format: | Article |
| Language: | English |
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BMC
2023-03-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07204-4 |
| _version_ | 1797863611775844352 |
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| author | Sam Kant Dixon B. Kaufman Lenuta Micsa Daniel C. Brennan |
| author_facet | Sam Kant Dixon B. Kaufman Lenuta Micsa Daniel C. Brennan |
| author_sort | Sam Kant |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-09T22:39:26Z |
| format | Article |
| id | doaj.art-7d5b5218a6a741709b1817eccac19c17 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-04-09T22:39:26Z |
| publishDate | 2023-03-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-7d5b5218a6a741709b1817eccac19c172023-03-22T12:17:40ZengBMCTrials1745-62152023-03-0124111010.1186/s13063-023-07204-4Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAESam Kant0Dixon B. Kaufman1Lenuta Micsa2Daniel C. Brennan3Department of Medicine, Johns Hopkins University School of MedicineDepartment of Surgery, School of Medicine and Public Health, University of Wisconsin-MadisonMedeor Therapeutics, Inc.Medeor Therapeutics, Inc.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.https://doi.org/10.1186/s13063-023-07204-4ToleranceKidney transplantationImmunotherapyImmunosuppression |
| spellingShingle | Sam Kant Dixon B. Kaufman Lenuta Micsa Daniel C. Brennan Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE Trials Tolerance Kidney transplantation Immunotherapy Immunosuppression |
| title | Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE |
| title_full | Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE |
| title_fullStr | Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE |
| title_full_unstemmed | Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE |
| title_short | Master protocol to assess the long-term safety in kidney transplant recipients who previously received Medeor’s cellular immunotherapy products: the MDR-105-SAE |
| title_sort | master protocol to assess the long term safety in kidney transplant recipients who previously received medeor s cellular immunotherapy products the mdr 105 sae |
| topic | Tolerance Kidney transplantation Immunotherapy Immunosuppression |
| url | https://doi.org/10.1186/s13063-023-07204-4 |
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