First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 26, 2019

Primary Completion Date

March 28, 2022

Study Completion Date

March 28, 2022

Conditions
Kidney Transplant
Interventions
BIOLOGICAL

LIS1

LIS1 is an induction treatment on top of maintenance immunosuppressive regimen. All patients from AD and TD cohort will receive the conventional immunosuppressive regimen: tacrolimus (0.2 mg/kg) / mycophenolic acid (MMF, 2x1000 mg) / prednisone (20 mg from day 2). This conventional treatment should be started and monitored for all patients independently of their participation in the clinical trial. Methylprednisolone 500 mg / 100 mL saline / 30 minutes will be administered before reperfusion during the surgery and on post operation day 1 just before LIS1 administration.

Trial Locations (1)

140 21

Institut klinické a experimentální medicíny, Prague

All Listed Sponsors
lead

Xenothera SAS

INDUSTRY

NCT04431219 - First in Human Study: LIS1, an Induction Treatment in Kidney Transplanted Patients | Biotech Hunter | Biotech Hunter