Comparing Everolimus and Reduced-dose Tacrolimus for BK Virus Infection in Kidney Transplant Patients
The Efficacy of Everolimus With Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus and Leflunomide in Treatment of BK Virus Infection in Kidney Transplantation Recipient
This study is testing if adding Everolimus to a lower dose of Tacrolimus can help kidney transplant patients with a stubborn BK virus infection feel better compared to just using the lower dose of Tacrolimus alone.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | King Chulalongkorn Memorial Hospital Academic / other |
| Locations | 1 site (Bangkok, Bangkok) |
| Trial ID | NCT04542733 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of Everolimus combined with reduced-dose Tacrolimus compared to reduced-dose Tacrolimus alone in treating BK virus infections in kidney transplant recipients. The study focuses on patients who have persistent BK viremia and have not responded to standard immunosuppression reduction. By utilizing an mTOR inhibitor like Everolimus, the trial seeks to determine if this approach can improve outcomes for patients suffering from this viral infection.
Who should consider this trial
Good fit: Ideal candidates for this study are kidney transplant recipients aged 18 and older with persistent BK viremia.
Not a fit: Patients with extremely high BK viral loads or those who have previously received treatment for BK virus-associated nephropathy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for kidney transplant recipients suffering from BK virus infections, potentially preserving kidney function and improving patient outcomes.
How similar studies have performed: Previous studies have shown promising results with mTOR inhibitors and leflunomide in treating BK virus infections, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Kidney transplant recipients at King Chulalongkorn Memorial Hospital * age \>= 18 years * persistent BK viremia \>1000 copies/mL at least 2 times in 3 weeks or single time \> 10000 copies/mL Exclusion Criteria: * BK VL \>10\^5 log * Previous BKVAN treatment * Drug hypersensitivity to mTORi or leflunomide
Where this trial is running
Bangkok, Bangkok
- King Chulalongkorn Memorial Hospital — Bangkok, Bangkok, Thailand (Recruiting)
Study contacts
- Principal investigator: Suwasin Udomkarnjananun, MD, MSc — Chulalongkorn University
- Study coordinator: Suwasin Udomkarnjananun, MD, MSc
- Email: suwasin.u@gmail.com
- Phone: +66899679885
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.