A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants
Not yet recruiting
Phase of Trial: Phase III
Latest Information Update: 11 Dec 2017
At a glance
- Drugs MDR 101 (Primary)
- Indications Renal transplant rejection
- Focus Registrational; Therapeutic Use
- Sponsors Medeor Therapeutics
- 30 Nov 2017 Status changed from planning to not yet recruiting.
- 10 May 2017 New trial record
- 28 Apr 2017 According to a Medeor Therapeutics media release, the company has received clearance from the U.S. Food and Drug Administration (FDA) for an Investigational New Drug (IND) application for the company's lead product candidate MDR-101. In addition, the FDA has agreed to a Special Protocol Assessment (SPA) for the design of a pivotal Phase III clinical study of MDR-101.