Phase 4
N=501
Safety/Efficacy of Induction Agents With Tacrolimus, MMF, and Rapid Steroid Withdrawal in Renal Transplant Recipients
Kidney Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00113269 ↗Enrolled (actual)
501
Serious AEs
51.7%
Results posted
Jul 2011
Primary outcome: Primary: Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months — 6.2; 9.4; 1.9; 17.5 Percentage of Patients — p=0.4889
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- basiliximab (Drug); rabbit anti-thymocyte globulin (Drug); tacrolimus (Drug); alemtuzumab (Drug); mycophenolate mofetil (Drug); steroids (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Astellas Pharma Inc
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Incidence of Biopsy-confirmed Acute Rejection (BCAR) at 6 Months |
6.2; 9.4; 1.9; 17.5 | 0.4889 |
| SECONDARY Overall Patient Incidence of BCAR |
15.7; 13.0; 9.8; 21.6 | 0.6533 |
| SECONDARY Efficacy Failure |
22.9; 29.0; 15.9; 24.6 | 0.4087 |
| SECONDARY Clinically Treated Acute Rejection |
22.9; 21.7; 12.8; 26.9 | 0.8742 |
| SECONDARY Time to First BCAR |
226; 49; 469; 13 | — |
| SECONDARY Graft Survival at 12 Months |
95.6; 92.1; 97.5; 95.1 | 0.4134 |
| SECONDARY Overall Graft Survival |
88.6; 82.6; 90.9; 91.2 | 0.3155 |
| SECONDARY Patient Survival at 12 Months |
98.6; 96.9; 98.1; 98.7 | 0.5265 |
| SECONDARY Overall Patient Survival |
95.7; 89.9; 93.9; 95.3 | 0.1797 |
| SECONDARY Renal Function Abnormalities Based on Creatinine Clearance |
0.882; 0.833; 0.906; 0.891; 0.976; 0.862 | 0.4735 |
| SECONDARY Renal Function Abnormalities Based on Serum Creatinine |
151.7; 155.9; 139.0; 138.2; 136.6; 152.0 | 0.5231 |
Summary
The purpose of this study is to compare the safety and efficacy of different induction agents (alemtuzumab, basiliximab or rabbit anti-thymocyte globulin) in renal transplant recipients treated with tacrolimus, mycophenolate mofetil (MMF) and a rapid steroid withdrawal.
Eligibility Criteria
Inclusion Criteria
- Recipient of a primary or re-transplanted deceased donor kidney or a primary or re-transplanted non-human leukocyte antigen (HLA) living donor kidney (ie., HLA identical or 0 antigen mismatch deceased donor kidneys are allowed).
Exclusion Criteria
- Patient has previously received an organ transplant other than a kidney
- Patient receiving chronic steroid therapy at time of transplant
Data sourced from ClinicalTrials.gov (NCT00113269). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.