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AzTrials

Lung TransplantationScanCLADNCT02936505

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

A study testing Cyclosporine, Mycophenolate mofetil (MMF) and Rabbit Anti thymocyte globulin in people with Lung Transplantation and Allografts, run by Vastra Gotaland Region at 5 sites in 4 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Lung Transplantation, Allografts
What is being tested?
Cyclosporine, Mycophenolate mofetil (MMF) and Rabbit Anti thymocyte globulin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
249 participants
Where
5 sitesin 4 countries
Study dates
12 Oct 2016to 30 Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 14Show fewer
  • 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.
  • Patients with donor greater than 75 years.
  • 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.
  • Patient unable to participate in the study for the full 36-month period
  • Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
  • 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

Trial locations and contacts

5 sites in 4 countries.

5 sites in 4 countries

Sweden2 sites

  • Sahlgrenska Univ Hospital

    Gothenburg

  • Skåne University Hospital

    Lund

Other trials in Sweden

Denmark1 site

  • Rigshospitalet

    Copenhagen

Other trials in Denmark

Finland1 site

  • Helsinki University Hospital

    Helsinki

Other trials in Finland

Norway1 site

  • Oslo University Hospital

    Oslo

Other trials in Norway

About this study

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

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.

Read the 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.

Being tested
Cyclosporine, Mycophenolate mofetil (MMF), Rabbit Anti thymocyte globulin, Corticosteroids, Tacrolimus
Keywords
chronic lung allograft dysfunction, cyclosporin, tacrolimus, Bronchiolitis Obliterans Syndrome, Restrictive Allograft Syndrome, CLAD, immunization, renal function, survival
Medical subject headings
Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclosporineDrug

    Also called Sandimmun Neural

    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)Drug

    Also called Cellcept

    MMF target dose: 2000 mg/day (1gx2):

    • 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 globulinDrug

    Also called Thymoglobulin®

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

  • CorticosteroidsDrug

    Also called Methylprednisolon

    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.

  • TacrolimusDrug

    Also called Advagraf®

    • 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.
Study groups in NCT02936505
Study groupRoleWhat they receive
Arm A:CyclosporineActive comparatorGroup A: Cyclosporine A, Mycophenolate mofetil (MMF) and corticosteroids according to local practice and approved label.
Receives: Drug: Cyclosporine; Drug: Mycophenolate mofetil (MMF); Drug: Rabbit Anti thymocyte globulin; Drug: Corticosteroids
Arm B:TacrolimusExperimentalGroup B: Tacrolimus (Advagraf), Mycophenolate mofetil (MMF) and corticosteroids.
Receives: Drug: Mycophenolate mofetil (MMF); Drug: Rabbit Anti thymocyte globulin; Drug: Corticosteroids; Drug: Tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients with incidence of CLAD

    The cumulative incidence of CLAD (including both BOS and RAS, as defined in the Appendix II) after lung transplantation.

    Measured: 36 months is primary outcome

  2. Number of patients with incidence of CLAD

    The cumulative incidence of CLAD (including both BOS and RAS, as defined by the Appendix II) at 48 months after lung transplantation.

    Measured: 48 months is outcome for the continuation study

  3. Number of patients with incidence of CLAD

    The cumulative incidence of CLAD (including both BOS and RAS, as defined by the Appendix II) at 60 months after lung transplantation.

    Measured: 60 months is outcome for continuation study

  4. Number of patients with incidence of CLAD

    The cumulative incidence of CLAD (including both BOS and RAS, as defined by the Appendix II) at 72 months after lung transplantation.

    Measured: 72 months is outcome for continuation study

Secondary outcomes (66)

  1. Glomerular Filtration Rate

    Renal function evaluated by measured glomerular filtration rate

    Measured: 3 months

  2. Primary graft dysfunction

    Cumulative incidence of primary graft dysfunction

    Measured: 72 hours

  3. Composite measure of freedom from AR, CLAD, graft and patient survival

    Composite measure of freedom from first event of AR, CLAD, graft survival, and patient survival

    Measured: 12 months

  4. Composite measure of freedom from AR, CLAD, graft and patient survival

    Composite measure of freedom from first event of AR, CLAD, graft survival, and patient

    Measured: 24 months

  5. Composite measure of freedom from AR, CLAD, graft and patient survival

    Composite measure of freedom from first event of AR, CLAD, graft survival, and patient

    Measured: 36 months

  6. Incidence of primary graft dysfunction

    cumulative incidence of primary graft dysfunction

    Measured: 72 hours

  7. Patient survival

    Patient survival

    Measured: 1 year

  8. Patient survival

    Patient survival

    Measured: 3 year

  9. Cumulative incidence of acute allograft rejection and CLAD

    The cumulative incidence of acute allograft rejection (AR) and CLAD. - Determined by clinical criteria, computed tomography (CT) and trans bronchial lung biopsy with broncho-alveolar lavage (BAL). - Number of rejections (cellular and antibody mediated), stratified by biopsy and non-biopsy verified rejections.

    Measured: 6 months

  10. Cumulative incidence of acute allograft rejection and CLAD

    The cumulative incidence of acute allograft rejection (AR) and CLAD. - Determined by clinical criteria, computed tomography (CT) and trans bronchial lung biopsy with broncho-alveolar lavage (BAL). - Number of rejections (cellular and antibody mediated), stratified by biopsy and non-biopsy verified rejections.

    Measured: 1 year

  11. Cumulative incidence of acute allograft rejection and CLAD

    The cumulative incidence of acute allograft rejection (AR) and CLAD. - Determined by clinical criteria, computed tomography (CT) and trans bronchial lung biopsy with broncho-alveolar lavage (BAL). - Number of rejections (cellular and antibody mediated), stratified by biopsy and non-biopsy verified rejections.

    Measured: 3 year

  12. Cumulative incidence of BOS and RAS

    The cumulative incidence of BOS and RAS

    Measured: 6 months

  13. Cumulative incidence of BOS and RAS

    The cumulative incidence of BOS and RAS

    Measured: 1 year

  14. Cumulative incidence of BOS and RAS

    The cumulative incidence of BOS and RAS

    Measured: 3 year

  15. Development of donor specific antibodies

    Development of donor specific antibodies (DSA) according to specific protocol.

    Measured: 12 months

  16. Development of donor specific antibodies

    Development of donor specific antibodies (DSA) according to specific protocol.

    Measured: 24 months

  17. Development of donor specific antibodies

    Development of donor specific antibodies (DSA) according to specific protocol.

    Measured: 36 months

  18. Renal function mGFR

    Renal function evaluated by measured glomerular filtration rate (mGFR), by Iohexol or Cr-EDTA clearance.

    Measured: 12 months

  19. Renal function mGFR

    Renal function evaluated by measured glomerular filtration rate (mGFR), by Iohexol or Cr-EDTA clearance.

    Measured: 24 months

  20. Renal function mGFR

    Renal function evaluated by measured glomerular filtration rate (mGFR), by Iohexol or Cr-EDTA clearance.

    Measured: 36 months

  21. Renal function cGFR

    Renal function evaluated by calculated glomerular filtration rate (cGFR), by three different Formulas.

    Measured: 3 months

  22. Renal function cGFR

    Renal function evaluated by calculated glomerular filtration rate (cGFR), by three different Formulas.

    Measured: 12 months

  23. Renal function cGFR

    Renal function evaluated by calculated glomerular filtration rate (cGFR), by three different Formulas.

    Measured: 24 months

  24. Renal function cGFR

    Renal function evaluated by calculated glomerular filtration rate (cGFR), by three different Formulas.

    Measured: 36 months

  25. Post Transplantation Diabetes Mellitus

    The cumulative incidence of Post Transplantation Diabetes Mellitus (PTDM) after transplantation as defined below. Cumulative incidence of

    ≥2 Fasting Plasma Glucose (FPG) ≥7,0 mmol/L ≥ 30 consecutive days apart. Oral hypoglycaemic treatment ≥30 consecutive days. Insulin ≥30 consecutive days. HgbA1c ≥6.5% (according to American Diabetes Association - ADA)Symptoms of Diabetes and Random Plasma Glucose (RPG) ≥ 11.1 mmol/L.

    2-hour Plasma Glucose (2-hPG) ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). Baseline OGTT will be performed pre-transplant.

    Measured: 6 months

  26. Post Transplantation Diabetes Mellitus

    The cumulative incidence of Post Transplantation Diabetes Mellitus (PTDM) after transplantation as defined below. Cumulative incidence of

    ≥2 Fasting Plasma Glucose (FPG) ≥7,0 mmol/L ≥ 30 consecutive days apart. Oral hypoglycaemic treatment ≥30 consecutive days. Insulin ≥30 consecutive days. HgbA1c ≥6.5% (according to American Diabetes Association - ADA) Symptoms of Diabetes and Random Plasma Glucose (RPG) ≥ 11.1 mmol/L. 2-hour Plasma Glucose (2-hPG) ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). Baseline OGTT will be performed pre-transplant.

    Measured: 12 months

  27. Post Transplantation Diabetes Mellitus

    The cumulative incidence of Post Transplantation Diabetes Mellitus (PTDM) after transplantation as defined below. Cumulative incidence of

    ≥2 Fasting Plasma Glucose (FPG) ≥7,0 mmol/L ≥ 30 consecutive days apart. Oral hypoglycaemic treatment ≥30 consecutive days. Insulin ≥30 consecutive days. HgbA1c ≥6.5% (according to American Diabetes Association - ADA) Symptoms of Diabetes and Random Plasma Glucose (RPG) ≥ 11.1 mmol/L. 2-hour Plasma Glucose (2-hPG) ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). Baseline OGTT will be performed pre-transplant.

    Measured: 24 months

  28. Post Transplantation Diabetes Mellitus

    The cumulative incidence of Post Transplantation Diabetes Mellitus (PTDM) after transplantation as defined below -Cumulative incidence of:

    ≥2 Fasting Plasma Glucose (FPG) ≥7,0 mmol/L ≥ 30 consecutive days apart. Oral hypoglycaemic treatment ≥30 consecutive days. Insulin ≥30 consecutive days. HgbA1c ≥6.5% (according to American Diabetes Association - ADA)Symptoms of Diabetes and Random Plasma Glucose (RPG) ≥ 11.1 mmol/L.

    2-hour Plasma Glucose (2-hPG) ≥ 11.1 mmol/L during an oral glucose tolerance test (OGTT). Baseline OGTT will be performed pre-transplant.

    Measured: 36 months

  29. Antidiabetic medication

    Use of antidiabetic medication

    Measured: 6 months

  30. Antidiabetic medication

    Use of antidiabetic medication

    Measured: 12 months

  31. Antidiabetic medication

    Use of antidiabetic medication

    Measured: 24 months

  32. Antidiabetic medication

    Use of antidiabetic medication

    Measured: 36 months

  33. Antihypertensive and lipid lowering drugs

    Incidence and number of antihypertensive and lipid lowering drug

    Measured: 12 months

  34. Antihypertensive and lipid lowering drugs

    Incidence and number of antihypertensive and lipid lowering drug

    Measured: 24 months

  35. Antihypertensive and lipid lowering drugs

    Incidence and number of antihypertensive and lipid lowering drug

    Measured: 36 months

  36. Proteinuria

    Development and magnitude of proteinuria

    Measured: 12 months

  37. Proteinuria

    Development and magnitude of proteinuria

    Measured: 24 months

  38. Proteinuria

    Development and magnitude of proteinuria

    Measured: 36 months

  39. Lipid profile

    Lipid profile (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, TSH, T4, HbA1c)

    Measured: 12 months

  40. Lipid profile

    Lipid profile (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, TSH, T4, HbA1c)

    Measured: 24 months

  41. Lipid profile

    Lipid profile (Total cholesterol, LDL-cholesterol, HDL-cholesterol, Triglycerides, TSH, T4, HbA1c)

    Measured: 36 months

  42. Cytomegalovirus

    Incidence of Cytomegalovirus (CMV) that required treatment (CMV-infection and CMV syndrome).

    Measured: 0-36 months

  43. Malignancy stratified by post-transplant lymphoproliferative disorder (PTLD) and all other cancers.

    Cumulative incidence of malignancy stratified by post-transplant lymphoproliferative disorder (PTLD) and all other cancers.

    Measured: 36 months

  44. Safety and tolerability

    Safety and tolerability

    Measured: 0-36 months

  45. Quality of life assessed by EQ5D Questionnaire

    Quality of life, the relative difference over time will be investigated after LTx, where 5 questions are raised and answer is between 11111 (no problems) and 33333 (extreme problems in all dimensions)

    Measured: 12 months

  46. Quality of life assessed by St Georges Respiratory Questionnaire (SGRQ)

    Quality of life, the relative difference over time will be investigated after LTx. The SGRQ total score ranges from 0 to 100 where 100 indicates the worst quality of life.

    Measured: 12 months

  47. Quality of life, assessed by EQ5D Questionnaire

    Quality of life, the relative difference over time will be investigated after LTx, where 5 questions are raised and answer is between 11111 (no problems) and 33333 (extreme problems in all dimensions).

    Measured: 24 months

  48. Quality of life, assessed by St Georges Respiratory Questionnaire (SGRQ)

    Quality of life, the relative difference over time will be investigated after LTx. The SGRQ total score ranges from 0 to 100 where 100 indicates the worst quality of life.

    Measured: 24 months

  49. Quality of life, assessed by EQ5D Questionnaire (SGRQ)

    Quality of life, the relative difference over time will be investigated after LTx, where 5 questions are raised and answer is between 11111 (no problems) and 33333 (extreme problems in all dimensions).

    Measured: 36 months

  50. Quality of life, assessed by St Georges Respiratory Questionnaire (SGRQ)

    Quality of life, the relative difference over time will be investigated after LTx. The SGRQ total score ranges from 0 to 100 where 100 indicates the worst quality of life.

    Measured: 36 months

  51. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 0h after administration, of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  52. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 1h after administration of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  53. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 2h after administration of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  54. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 3h after administration of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  55. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 4h after administration of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  56. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 6h after administration of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  57. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics (from whole blood concentrations from at 8h after administration and of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  58. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics (from whole blood concentrations from at 10h after administration and of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  59. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics (from whole blood concentrations at 12h after administration and of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  60. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 23h after administration and of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  61. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics from whole blood concentrations at 24h after administration and of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  62. Pharmacokinetics, of the Tacrolimus drug in patients in the CF sub group population

    Define the pharmacokinetics as an AUC construction, of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: week 4

  63. Pharmacokinetics of the Tacrolimus drug in patients in the CF sub group

    Define the pharmacokinetics as an AUC construction, of Tacrolimus in non-CF patients (n=12) and all included CF patients (n=15-20) undergoing primary lung transplantation (LTx) treated with an Advagraf® based-immunosuppression.

    Measured: 6 months

  64. Immunological equipotency of tacrolimus and cyclosporine A

    Immunological equipotency of tacrolimus once daily (OD) and cyclosporine A twice daily (BiD) in vivo and in vitro, according to separate protocol.

    Measured: 0-36 months

  65. Occurrence of treatment failures

    Occurrence of treatment failures up to or at 36 months; defined as a composite endpoint of graft loss, death, loss to follow up or discontinuation due to lack of efficacy or toxicity (at least one condition must be present).

    Measured: 0-36 months

  66. Recovery of right heart function

    Recovery of right heart function irrespective of diagnosis in patients with pulmonary arterial hypertension (PAH, categories 1-5 according to WHO 1-5).

    Measured: 0-36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2016 (estimated)
  2. Study start12 Oct 2016
  3. Primary completion30 Oct 2025 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
249 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02936505
Sponsor's protocol ID
Version 8.0
Other IDs
154-16, 2015-004137-27, T-798-16 (amendement), T002-17 (amendement), T 055-18 (amendement), T568-18 (amendement), 2019-06057 (amendement), 2021-05380-02 (amendement)
Acronym
ScanCLAD
Status last verified
Apr 2023
First submitted
15 Oct 2016
Last updated
26 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Potentially this can be done, but needs to be according to GDPR. Figures with pulmonary function tests over time and related to CLAD are constructed in the study.

Publications

  • 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.

    PubMed 31993943

  • Joo S, Dhaygude K, Krebs R, Holmstrom E, Puhka M, Laitinen S, Dellgren G, Magnusson J, Holmberg EC, Svahn J, Lund TK, Leuckfeld I, Raivio P, Helantera I, Aberg F, Syrjala SO, Nykanen AI, Lemstrom KB. Extracellular vesicles in lung donor plasma: Potential indicators of donor organ quality. J Thorac Cardiovasc Surg. 2025 Sep;170(3):902-913. doi: 10.1016/j.jtcvs.2025.03.012. Epub 2025 Mar 19.

    PubMed 40118141

  • 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.

    PubMed 37703908

Questions about this trial

What is this clinical trial studying?

A study testing Cyclosporine, Mycophenolate mofetil (MMF) and Rabbit Anti thymocyte globulin in people with Lung Transplantation and Allografts, run by Vastra Gotaland Region at 5 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Sweden, Denmark, Finland, Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients with incidence of CLAD (time frame: 36 months is primary outcome). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02936505, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.

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