Phase 4
Completed N=40
Safety and Efficacy Study of Everolimus to Treat BK Virus Infection in Kidney Transplant Recipients
BK Virus Infection
Source: ClinicalTrials.gov NCT01624948 ↗
Enrolled (actual)
40
Serious AEs
12.5%
Results posted
Aug 2016
Primary outcomePrimary: Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia — 11; 8 participants — p=0.53
◆ Published Evidence
Emerging
8citations · ~4 / year
Interventions for BK virus infection in kidney transplant recipients.
Summary
This study is examining the safety and efficacy of converting anti-rejection therapy from mycophenolic acid (MPA) to Zortress (everolimus) in renal transplant recipients with BK virus infection.
The study will also determine if immune monitoring tests can detect an association between BK virus infection and transplant rejection episodes, based on the specific BKV infection treatment regimen.
The investigators hypothesize that an anti-rejection regimen with Zortress (everolimus) and tacrolimus + prednisone will be superior to a standard regimen of reduced dose MPA and tacrolimus + prednisone in patients who have undergone renal transplantation and have active BKV infections.
Linked Publications
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Interventions for BK virus infection in kidney transplant recipients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Reduction of BK Viruria and/or Clearance of BK Viremia |
11; 8 | 0.53 |
| SECONDARY Evaluation for the Development of BK Virus Nephropathy or Doubling of BK Viremia Levels |
2; 2 | — |
| SECONDARY p70S6 Kinase Phosphorylation |
5002; 4353 | 0.67 |
| SECONDARY Cholesterol |
212; 170 | 0.01 sig |
| SECONDARY Proteinuria |
0.16; 0.23 | — |
| SECONDARY Median Between the Calculated Mean Residual Expression of NFAT-regulated Genes |
46.35; 29.12 | 0.49 |
Eligibility Criteria
Inclusion Criteria
- Male or female renal transplant recipients 18-75 years of age (primary or re-transplant)
- Recipients of cadaveric, living unrelated or living related donor kidney
- Baseline immunosuppression (IS) consisting of tacrolimus, MPA, and prednisone
- Patients with BK viruria ≥ 1 million copies/mL and/or viremia (> 500 copies/mL) found on routine BKV screening.
- Patients who have given written informed consent to participate in the study
Exclusion Criteria
- Patients who are ABO incompatible transplants
- Patients with an abnormal liver profile such as Alanine Aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase, or total bilirubin > 3x ULN at the time of randomization
- Patients with severe total hypercholesterolemia (> 350 mg/dL) or total hypertriglyceridemia (> 500 mg/dL). Patients on lipid lowering drugs with controlled hyperlipidemia are acceptable.
- Patients with a platelet count 40 mIU/mL and estradiol 500mg/day
- Patients with Estimated Glomerular Filtration Rate (eGFR) < 40 ml/min
- Patients who have undergone desensitization
Data sourced from ClinicalTrials.gov (NCT01624948) and the linked publication. 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.