News & Events
-
October 11, 2023
Applying propensity methods to the United States transplant registry for external real-world evidence control arms for 5-year survival in the BENEFIT study
Amanda Klein, Alice Toll, Darren Stewart, William E. Fitzsimmons Abstract To address the challenges of assessing the impact of a reasonably likely surrogate endpoint on long-term graft survival in prospective kidney transplant clinical trials, the Transplant Therapeutics Consortium established a real-world evidence workgroup evaluating the scientific value of using transplant registry data as an external...... -
September 25, 2023
Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn B. Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons. on behalf of the Transplant Therapeutics Consortium Abstract New immunosuppressive therapies that improve long-term graft survival are...... -
September 25, 2023
Qualifying a novel clinical trial endpoint (iBOX) predictive of long-term kidney transplant outcomes
Amanda Klein, Alexandre Loupy, Mark Stegall, Ilkka Helanterä, Luke Kosinski, Eric Frey, Olivier Aubert, Gillian Divard, Kenneth Newell, Herwig-Ulf Meier-Kriesche, Roslyn B. Mannon, Thomas Dumortier, Varun Aggarwal, Jagdeep T. Podichetty, Inish O’Doherty, Ahmed Osama Gaber, William E. Fitzsimmons. on behalf of the Transplant Therapeutics Consortium Abstract New immunosuppressive therapies that improve long-term graft survival are...... -
July 25, 2023
Longitudinal estimated glomerular filtration rate (eGFR) modeling in long-term renal function to inform clinical trial design in kidney transplantation
Authored by: Luke Kosinski, Eric Frey, Amanda Klein, Inish O’Doherty, Klaus Romero, Mark Stegall, Ilkka Helanterä, Ahmed Osama Gaber, William E. Fitzsimmons, Varun Aggarwal, Transplant Therapeutics Consortium (TTC) Abstract Kidney transplantation is the preferred treatment for individuals with end-stage kidney disease. From a modeling perspective, our understanding of kidney function trajectories after transplantation remains limited....... -
July 20, 2023
Acute Rejection After Kidney Transplant—An Endpoint Not Predictive of Treatment Effect on Graft Survival
Fitzsimmons, William E. PharmD, MS1,2; Naesens, Maarten MD, PhD3,4...