A pivotal Phase 3 clinical study of MDR-101 in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants.
Phase of Trial: Phase III
Latest Information Update: 10 May 2017
At a glance
- Drugs MDR 101 (Primary)
- Indications Renal transplant rejection
- Focus Registrational; Therapeutic Use
- Sponsors Medeor Therapeutics
- 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.
- 28 Apr 2017 According to a Medeor Therapeutics media release, company plans to initiate this trial in the second half of 2017.