Active — Not RecruitingNot Applicable

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

Denmark, Finland, Norway249 participantsStarted 2016-10-12

Plain-language 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.

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
✓. Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 36 months.

Exclusion criteria

✕. Recipients of multiorgan transplant, and or previously transplanted with any organ, including previous lung transplantation.
✕. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study.
✕. Donor lung cold ischemic time \> 12 hours.
✕. Patients who previously have been treated with anti-thymocyte globulin preparations (e.g. ATG-Fresenius®, Thymoglobulin®).
✕. Patients who are recipients of ABO-incompatible transplants.
✕. Patients with platelet count \< 50,000/mm3 at the evaluation before transplantation.
✕. Patients who are unlikely to comply with the study requirements.
✕. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.

What they're measuring

Number of patients with incidence of CLAD

Timeframe: 36 months is primary outcome

Number of patients with incidence of CLAD

Timeframe: 48 months is outcome for the continuation study

Number of patients with incidence of CLAD

Timeframe: 60 months is outcome for continuation study

Number of patients with incidence of CLAD

Timeframe: 72 months is outcome for continuation study

Trial details

NCT IDNCT02936505

SponsorVastra Gotaland Region

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-10-30

View on ClinicalTrials.gov More Lung Transplantation trials

Plain-language summary

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
✓. Patient willing and capable of giving written informed consent for study participation and anticipated to be able to participate in the study for 36 months.

Exclusion criteria

✕. Recipients of multiorgan transplant, and or previously transplanted with any organ, including previous lung transplantation.
✕. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study.
✕. Donor lung cold ischemic time \> 12 hours.
✕. Patients who previously have been treated with anti-thymocyte globulin preparations (e.g. ATG-Fresenius®, Thymoglobulin®).
✕. Patients who are recipients of ABO-incompatible transplants.
✕. Patients with platelet count \< 50,000/mm3 at the evaluation before transplantation.
✕. Patients who are unlikely to comply with the study requirements.
✕. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.

What they're measuring

Number of patients with incidence of CLAD

Timeframe: 36 months is primary outcome

Number of patients with incidence of CLAD

Timeframe: 48 months is outcome for the continuation study

Number of patients with incidence of CLAD

Timeframe: 60 months is outcome for continuation study

Number of patients with incidence of CLAD

Timeframe: 72 months is outcome for continuation study