Ignite Creation Date:
2024-05-06 @ 2:45 PM
Last Modification Date:
2024-10-26 @ 1:36 PM
Study NCT ID:
NCT04415476
Status:
WITHDRAWN
Last Update Posted:
2023-05-06
First Post:
2020-05-13
Brief Title:
Standard Therapy Using Tacrolimus Mycophenolate Mofetil and Prednisone For Chronic Lung Transplant Rejection BOS
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
A Randomized Open-labelControlled Phase II b Study to Demonstrate Efficacy and Safety of Sirolimus Chronic Rejection After Lung Transplant
Status:
WITHDRAWN
Status Verified Date:
2020-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study did not proceed to IRB approval
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a prospective single-center open-label randomized controlled pilot
study in the treatment of chronic rejection CR defined as grade 1 and 2
BOS in adult recipients of a pulmonary allograft single or double lungsTo assess the efficacy and safety of sirolimus plus tacrolimus and prednisone
S compared to standard therapy tacrolimus mycophenolate mofetil
MMF and prednisone ST for chronic rejection defined as grades 1 and 2
bronchiolitis obliterans syndrome BOS BOS defined as 20 decline
from maximal post-transplant FEV1
study in the treatment of chronic rejection CR defined as grade 1 and 2
BOS in adult recipients of a pulmonary allograft single or double lungsTo assess the efficacy and safety of sirolimus plus tacrolimus and prednisone
S compared to standard therapy tacrolimus mycophenolate mofetil
MMF and prednisone ST for chronic rejection defined as grades 1 and 2
bronchiolitis obliterans syndrome BOS BOS defined as 20 decline
from maximal post-transplant FEV1
Detailed Description:
This is a prospective single-center open-label randomized controlled pilot
study in the treatment of chronic rejection CR defined as grade 1 and 2
BOS in adult recipients of a pulmonary allograft single or double lungs
Patients meeting entry criteria shall demonstrate a sustained decline in FEV1
having met stage 1 or 2 BOS Patients randomized to the study arm will be
treated with Sirolimus S orally in place of MMF in addition to tacrolimus
and prednisone compared to those patients randomized to defined ST alone
tacrolimus MMF and prednisone The trial duration will be approximately
Primary endpoints will include
Efficacy failure between ST and S randomized group investigational treatment regimens will be determined at 96 weeks after the last patient is randomization and enrolled at approximately study year 2 The control arm will receive standard of care treatment ST and immunosuppression according to the University of Maryland lung transplant protocol Efficacy failure will be defined as the combined end point of progression of BOS defined as at least a 20 decline from the initial randomization FEV1 value confirmed by two separate measurements three weeks apart or more or re-transplantation or death The co-primary end point of FEV1 and FVC changes to define functional stabilization in the S arm compared to ST is to be completed when the last patient randomized patient 30 has been enrolled for 2 years as well
Efficacy of S is to be assessed using following parameters to determine its effect on lung function
1 Forced expiratory volume in one second FEV1
2 Forced vital capacity FVC
3 FEF 25-75
Secondary endpoints will include
General S tolerability
Incidence and severity of adverse events AE
Changes in clinical laboratory parameters from baseline after randomization
Changes in vital signs
Changes in physical examinations
Incidence of infections
Average maintenance doses of calcineurin inhibitors antimetabolite agents and corticosteroids
Number of courses of augmented immunosuppressants
Number and days of hospitalization
Incidence of malignancies
Overall mortality including transplant-related mortality
Retransplantation
study in the treatment of chronic rejection CR defined as grade 1 and 2
BOS in adult recipients of a pulmonary allograft single or double lungs
Patients meeting entry criteria shall demonstrate a sustained decline in FEV1
having met stage 1 or 2 BOS Patients randomized to the study arm will be
treated with Sirolimus S orally in place of MMF in addition to tacrolimus
and prednisone compared to those patients randomized to defined ST alone
tacrolimus MMF and prednisone The trial duration will be approximately
Primary endpoints will include
Efficacy failure between ST and S randomized group investigational treatment regimens will be determined at 96 weeks after the last patient is randomization and enrolled at approximately study year 2 The control arm will receive standard of care treatment ST and immunosuppression according to the University of Maryland lung transplant protocol Efficacy failure will be defined as the combined end point of progression of BOS defined as at least a 20 decline from the initial randomization FEV1 value confirmed by two separate measurements three weeks apart or more or re-transplantation or death The co-primary end point of FEV1 and FVC changes to define functional stabilization in the S arm compared to ST is to be completed when the last patient randomized patient 30 has been enrolled for 2 years as well
Efficacy of S is to be assessed using following parameters to determine its effect on lung function
1 Forced expiratory volume in one second FEV1
2 Forced vital capacity FVC
3 FEF 25-75
Secondary endpoints will include
General S tolerability
Incidence and severity of adverse events AE
Changes in clinical laboratory parameters from baseline after randomization
Changes in vital signs
Changes in physical examinations
Incidence of infections
Average maintenance doses of calcineurin inhibitors antimetabolite agents and corticosteroids
Number of courses of augmented immunosuppressants
Number and days of hospitalization
Incidence of malignancies
Overall mortality including transplant-related mortality
Retransplantation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None