Delayed Graft Function Clinical Trial
Official title:
Comparison of a Tacrolimus/Sirolimus/Prednisone Regimen Versus Tacrolimus/Azathioprine/Prednisone Immunosuppressive Regimen in Lung Transplantation
The purpose of this study is to compare the safety and effectiveness of two different anti-rejection drug regimens.
This multicenter prospective, randomized controlled clinical trial compared the open label
use of sirolimus with that of azathioprine in a tacrolimus-based immunosuppression regimen.
Eligible patients were identified during a 90-day screening period immediately after
transplantation and randomized via a computer-generated scheme. Patient randomization was
stratified according to center and rejection status in the first 90 days after
transplantation. All patients received IL-2 receptor antagonist induction therapy,
tacrolimus, azathioprine, and corticosteroids until 90 days after transplantation. At 90
days after transplantation, patients were randomized at a 1:1 ratio to either continue
azathioprine or change from azathioprine to sirolimus.
The dosing and levels of immunosuppressive medications were standardized for all patients
included in this study. Tacrolimus was dosed at 0.04 mg/kg twice daily with target trough
levels between 5 and 15 ng/ml, azathioprine was administered at 2 mg/kg daily with dose
adjustments for leukopenia, sirolimus was initially dosed at 2 mg/day with target trough
levels between 5 and 15 ng/ml, and prednisone was tapered to not more than 10 mg/day by 3
months after transplantation. All patients received induction therapy with either daclizumab
or basiliximab as per the product package insert.
In addition, prophylactic antimicrobials were standardized among the participating sites.
All patients with either donor and/or recipient cytomegalovirus (CMV)-positive serostatus
received either intravenous ganciclovir or oral valganciclovir for a total of 90 days. Lung
transplant recipients who were negative for both donor and recipient CMV serostatus received
valacyclovir for 90 days. Antifungal prophylaxis was determined by each site. Pneumocystis
jiroveci prophylaxis was continued throughout the study. Lipid-lowering medications were
recommended according to the National Cholesterol Education Program guidelines.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Withdrawn |
NCT02312115 -
Delayed Renal Allograft Function and Furosemide Treatment
|
Phase 2 | |
Completed |
NCT02134314 -
C1INH Inhibitor Preoperative and Post Kidney Transplant to Prevent DGF & IRI
|
Phase 1/Phase 2 | |
Completed |
NCT02346968 -
Evaluation of CAF22 After Renal Transplantation
|
||
Completed |
NCT01794663 -
Placebo-Controlled Study to Evaluate the Safety and Efficacy of OPN-305 in Preventing Delayed Renal Graft Function
|
Phase 2 | |
Completed |
NCT00298181 -
YSPSL for Prevention of Delayed Graft Function Part A
|
Phase 1/Phase 2 | |
Not yet recruiting |
NCT05166460 -
Novel Cooling Device for the Elimination of Warm Ischemia During Renal Transplantation
|
N/A | |
Recruiting |
NCT03071536 -
Furosemide Stress Test Predicting Early Graft Function in Kidney Transplantation
|
N/A | |
Not yet recruiting |
NCT05513807 -
Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant
|
Phase 3 | |
Recruiting |
NCT04005469 -
Safety and Efficacy of Treprostinil (Remodulin®) In Reducing Ischemia-Reperfusion Injury During Kidney Transplantation
|
Phase 1/Phase 2 | |
Completed |
NCT01848249 -
Deceased Donor Biomarkers and Recipient Outcomes
|
||
Active, not recruiting |
NCT02474667 -
Reduce the Severity of DGF in Recipients of a Deceased Donor Kidney
|
Phase 3 | |
No longer available |
NCT02026934 -
CliniMACS® CD34+ Reagent System for Expanded Access Use
|
N/A | |
Terminated |
NCT00217152 -
A Kidney Transplant Study to Look at the Effects of Taking Fixed Doses of CellCept Versus Taking Doses of CellCept Based on the Concentration of CellCept in the Blood When Taking Full or Reduced Dose Calcineurin Inhibitors
|
Phase 4 | |
Recruiting |
NCT05430620 -
Intermittent Versus Continuous Surface O2 During HMP of DCD Kidneys
|
Phase 3 | |
Completed |
NCT03864926 -
Envarsus in Delayed Graft Function (E-DGF)
|
Phase 4 | |
Recruiting |
NCT06367205 -
Norepinephrine Infusion Combined With Goal-directed Fluid Therapy in Patients Undergoing Kidney Transplantations
|
N/A | |
Completed |
NCT02610296 -
QPI-1002 for Prevention of Delayed Graft Function in Recipients of an Older Donor Kidney Transplant
|
Phase 3 | |
Active, not recruiting |
NCT02568696 -
Intra-graft Coagulation Events in Clinical Renal Transplantation and Delayed Graft Function
|
||
Recruiting |
NCT01837043 -
Early Conversion From CNI to Belatacept in Renal Transplant Recipients With Delayed and Slow Graft Function
|
Phase 2 | |
Terminated |
NCT01878786 -
A Pilot Study Comparing the Safety and Efficacy of Everolimus With Other Medicines in Recipients of ECD/DCD Kidneys
|
Phase 2/Phase 3 |