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ACTIVE NOT RECRUITING
NCT02936505
NA

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

Sponsor: Vastra Gotaland Region

View on ClinicalTrials.gov

Summary

A controlled randomized, open-label, multi-centre study evaluating if an immunosuppressive protocol, based on ATG-induction, once daily tacrolimus-dose (Advagraf®), mycophenolate mofetil and corticosteroid reduces the incidence of chronic lung allograft dysfunction (CLAD) after lung transplantation, in comparison with a standard cyclosporin-based protocol.

Official title: A Scandinavian Controlled, Randomized, Open-label, and Multi-centre Study Evaluating if Once-daily Tacrolimus or Twice-daily Cyclosporin, Reduces the 3-year Incidence of Chronic Lung Allograft Dysfunction After Lung Transplantation

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

249

Start Date

2016-10-12

Completion Date

2026-10-30

Last Updated

2023-04-26

Healthy Volunteers

No

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.

Locations (5)

Rigshospitalet

Copenhagen, Denmark

Helsinki University Hospital

Helsinki, Finland

Oslo University Hospital

Oslo, Norway

Sahlgrenska Univ Hospital

Gothenburg, Sweden

Skåne University Hospital

Lund, Sweden