Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.

NAActive, not recruitingINTERVENTIONAL
Enrollment

249

Participants

Timeline

Start Date

October 12, 2016

Primary Completion Date

October 30, 2025

Study Completion Date

October 30, 2026

Conditions
Lung TransplantationAllografts
Interventions
DRUG

Cyclosporine

"Cyclosporin A (Sandimmun Neoral® or similar):~* Cyclosporin A given orally pretransplant in the dose of 2-3 mg/kg.~* Continued postop day 1 in the dose of 3mg/kgx2, according to local practice and blood concentration: 0-3 months 250-300; 3-6 months 200-250; 6-12 months 150-200; \>12 months 100-150 ng/ml. Cyclosporine A will be administered twice daily."

DRUG

Mycophenolate mofetil (MMF)

"MMF target dose: 2000 mg/day (1gx2):~o Controlled by a single Area Under the Curve (AUC) measurement day 90 with a target AUC between 40 and 60 mg.h/L and corrected accordingly."

DRUG

Rabbit Anti thymocyte globulin

Induction therapy: Thymoglobulin® (Rabbit Anti thymocyte globulin)(1.5 mg/kg given immediately postoperatively).

DRUG

Corticosteroids

"Corticosteroids:~* Day 0 (day of lung transplantation); 500+500mg methylprednisolone iv. before reperfusion, i.e. restoration of blood flow into the transplanted allograft.~* From day 1: Initiated at 0.2 mg/kg/day; tapered to 0.1 mg/kg 3-6 months; less than 0,1 mg/kg \> 6 months."

DRUG

Tacrolimus

"* Tacrolimus should be given orally pretransplant in the dose of 0.1 mg/kg.~* Continued postop day 1 according to local practice and blood concentration: 0-3 months 10-14, 3-6 months 8-12, 6-12 months 8-10, \>12 months 6-8 ng/ml. Tacrolimus will be administered once daily."

Trial Locations (5)

Unknown

Rigshospitalet, Copenhagen

Helsinki University Hospital, Helsinki

Oslo University Hospital, Oslo

Sahlgrenska Univ Hospital, Gothenburg

Skåne University Hospital, Lund

All Listed Sponsors
collaborator

Oslo University Hospital

OTHER

collaborator

Helsinki University Central Hospital

OTHER

collaborator

Skane University Hospital

OTHER

collaborator

Copenhagen University Hospital, Denmark

OTHER

lead

Vastra Gotaland Region

OTHER_GOV

NCT02936505 - Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD. | Biotech Hunter | Biotech Hunter