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

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.

Conditions

• Lung Transplantation
• Allografts

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.

Sponsors & Collaborators

• Oslo University Hospital

  collaborator OTHER

• Helsinki University Central Hospital

  collaborator OTHER

• Skane University Hospital

  collaborator OTHER

• Copenhagen University Hospital, Denmark

  collaborator OTHER

• Vastra Gotaland Region

  lead OTHER_GOV

Principal Investigators

• Göran Dellgren, MD, PhD · Sahlgrenska Univ Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-12

Primary Completion

2025-10-30

Completion

2026-10-30

Countries

• Denmark
• Finland
• Norway
• Sweden

Study Locations