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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

249 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-12

Study Completion Date

2026-10-30

Brief Summary

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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.

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Detailed Description

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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

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Lung Transplantation Allografts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A:Cyclosporine

Group A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.

Group Type ACTIVE_COMPARATOR

Cyclosporine

Intervention Type DRUG

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.

Mycophenolate mofetil (MMF)

Intervention Type DRUG

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.

Rabbit Anti thymocyte globulin

Intervention Type DRUG

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

Corticosteroids

Intervention Type DRUG

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.

Arm B:Tacrolimus

Group B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.

Group Type EXPERIMENTAL

Mycophenolate mofetil (MMF)

Intervention Type DRUG

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.

Rabbit Anti thymocyte globulin

Intervention Type DRUG

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

Corticosteroids

Intervention Type DRUG

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.

Tacrolimus

Intervention Type DRUG

* 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Rabbit Anti thymocyte globulin

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

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Sandimmun Neural Cellcept Thymoglobulin® Methylprednisolon Advagraf®

Eligibility Criteria

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Inclusion Criteria

1. Male or female lung recipients 18-70 years of age undergoing primary double (including size reduction) lung transplantation.
2. 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

1. Recipients of multiorgan transplant, and or previously transplanted with any organ, including previous lung transplantation.
2. Patients with hypersensitivity to, or other reasons to not be able to take the immunosuppressive drugs used in the study.
3. Donor lung cold ischemic time \> 12 hours.
4. Patients who previously have been treated with anti-thymocyte globulin preparations (e.g. ATG-Fresenius®, Thymoglobulin®).
5. Patients who are recipients of ABO-incompatible transplants.
6. Patients with platelet count \< 50,000/mm3 at the evaluation before transplantation.
7. Patients who are unlikely to comply with the study requirements.
8. Patients, and/or those receiving organs from donors, who are positive for HIV, Hepatitis B surface antigen or Hepatitis C virus.
9. Patients with donor greater than 75 years.
10. Patient who have received an unlicensed drug or therapy within one month prior to study entry or if such therapy is to be instituted post-transplantation.
11. Patient unable to participate in the study for the full 36-month period
12. Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
13. Females capable of becoming pregnant must have a negative pregnancy test prior to randomization.

Females are recommended to practice a medically approved method of birth control for the duration of the study and a period of 8 weeks following discontinuation of study medication, even where there has been a history of infertility

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Göran Dellgren

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Göran Dellgren, MD, PhD

Role: STUDY_CHAIR

Sahlgrenska Univ Hospital

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status

Helsinki University Hospital

Helsinki, , Finland

Site Status

Oslo University Hospital

Oslo, , Norway

Site Status

Sahlgrenska Univ Hospital

Gothenburg, , Sweden

Site Status

Skåne University Hospital

Lund, , Sweden

Site Status

Countries

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Denmark Finland Norway Sweden

References

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Dellgren G, Lund TK, Raivio P, Leuckfeld I, Svahn J, Magnusson J, Riise GC. Design and Rationale of a Scandinavian Multicenter Randomized Study Evaluating if Once-Daily Tacrolimus Versus Twice-Daily Cyclosporine Reduces the 3-year Incidence of Chronic Lung Allograft Dysfunction After Lung Transplantation (ScanCLAD Study). Adv Ther. 2020 Mar;37(3):1260-1275. doi: 10.1007/s12325-020-01224-1. Epub 2020 Jan 28.

Reference Type BACKGROUND

PMID: 31993943 (View on PubMed)

Dellgren G, Lund TK, Raivio P, Leuckfeld I, Svahn J, Holmberg EC, Olsen PS, Halme M, Fiane A, Lindstedt S, Riise GC, Magnusson J. Effect of once-per-day tacrolimus versus twice-per-day ciclosporin on 3-year incidence of chronic lung allograft dysfunction after lung transplantation in Scandinavia (ScanCLAD): a multicentre randomised controlled trial. Lancet Respir Med. 2024 Jan;12(1):34-44. doi: 10.1016/S2213-2600(23)00293-X. Epub 2023 Sep 10.

Reference Type DERIVED

PMID: 37703908 (View on PubMed)