NCT02936505

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Vastra Gotaland Region · Other Government
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Study purpose: To evaluate whether the use of a once-daily tacrolimus-dose regimen (Advagraf®), based on anti-thymocyte globulin (Thymoglobulin®) induction, mycophenolate mofetil (MMF) and corticosteroids, reduces the cumulative incidence of CLAD after de novo lung transplantation at 36 months, in comparison with a twice-daily cyclosporin-based protocol, otherwise identical between groups.

Conditions

• Lung Transplantation
• Allografts

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-10-12
• Primary completion: 2025-10-30
• Completion: 2026-10-30
• First posted: 2016-10-18
• Last updated: 2023-04-26

Locations

5 sites across 4 countries: Denmark, Finland, Norway, Sweden