drugset / Trial / NCT02936505
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
Active not recruiting
249 enrolled
Vastra Gotaland Region
Copenhagen University Hospital, Denmark · collabHelsinki University Central Hospital · collabOslo University Hospital · collabSkane University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-10-12
- Primary completion
- 2025-10-30
- Completion
- 2026-10-30
Outcome
Met primary endpoint
paper CLAD occurred in 48 patients (cumulative incidence 39% [95% CI 31-48]) in the ciclosporin group and 16 patients (13% [8-21]) in the tacrolimus group PMID 37703908 ↗
paper hazard ratio [HR] 0·28 [95% CI 0·15-0·52], log-rank p<0·0001 PMID 37703908 ↗
Publications
- Background 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclosporine | Peptide | 3 mg/kg | Oral |
| Subject | Tacrolimus | Small molecule | 0.1 mg/kg | Oral |
| Background | Methylprednisolone | Other / unclassified | 0.1 mg/kg | — |
| Background | Mycophenolate mofetil (MMF) | Unknown | 2000 mg | — |
| Background | rabbit anti-thymocyte globulin | Protein / enzyme biologic | 1.5 mg/kg | — |
Indications
No indication recorded.