N/A
Completed N=170
Study Cyclosporine (CsA) Versus Tacrolimus (Tacro) After Campath Induction in Kidney Transplantation
Acute Graft Rejection · Chronic Allograft Nephropathy · Polyomavirus-related Transplant Nephropathy
Source: ClinicalTrials.gov NCT01346397 ↗
Enrolled (actual)
170
Serious AEs
14.7%
Results posted
Nov 2016
Primary outcomePrimary: Patient Survival — 96.4; 96.3 percentage of participants
Summary
After alemtuzumab induction, followed with kidney transplantation, patients will be randomly assigned to receive either tacrolimus or cyclosporine microemulsion in combination with mycophenolates. Patients will be followed including protocol biopsy at 1, 12, 36, 60 month posttransplant, regular nuclein acid testing (NAT) for cytomegalovirus (CMV), Epstein-Barr virus (EBV) and BK virus (BKV) in urine and blood.
The investigation is undertaken to clarify the reason for equal survival rates for patients on cyclosporine and tacrolimus despite the lower rejection rate on tacrolimus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patient Survival |
96.4; 96.3 | — |
| PRIMARY Graft Survival |
84.6; 86.2 | — |
Eligibility Criteria
Inclusion Criteria
- first kidney allograft recipients
- alemtuzumab induction
Exclusion Criteria
- CNI intolerance
Data sourced from ClinicalTrials.gov (NCT01346397). 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. Informational only — not medical advice.