Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2026-02-27 @ 4:33 PM
Study NCT ID:
NCT02936505
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-04-26
First Post:
2016-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study Evaluating Two Treatment Protocols for Immunosuppressive Drugs. Looking at 3-year Incidence of CLAD.
Sponsor:
Vastra Gotaland Region
Organization:
Study Overview
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ScanCLAD
Brief 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.
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 154-16 | OTHER | EC, Gothenburg, Sweden | View | |
| 2015-004137-27 | EUDRACT_NUMBER | None | View | |
| T-798-16 (amendement) | OTHER | EC, Gothenburg, Sweden | View | |
| T002-17 (amendement) | OTHER | EC, Gothenburg, Sweden | View | |
| T 055-18 (amendement) | OTHER | EC, Gothenburg, Sweden | View | |
| T568-18 (amendement) | OTHER | EC, Gothenburg, Sweden | View | |
| 2019-06057 (amendement) | OTHER | EC (EPM), Gothenburg, Sweden | View | |
| 2021-05380-02 (amendement) | OTHER | EC (EPM), Gothenburg, Sweden | View |