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The Efficacy of Everolimus with Reduced-dose Tacrolimus Versus Reduced-dose Tacrolimus in Treatment of BK Virus Infection in Kidney Transplantation Recipient

Launched by KING CHULALONGKORN MEMORIAL HOSPITAL · Sep 2, 2020

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Kidney Transplantation M Tor Inhibitor Leflunomide Bk Virus

ClinConnect Summary

This clinical trial is studying how effective a medication called everolimus, combined with a lower dose of another drug called tacrolimus, is in treating BK virus infections in kidney transplant recipients. BK virus can lead to serious kidney problems in patients who have received a transplant, and the usual treatment involves reducing the medications that help prevent the body from rejecting the new kidney. However, this trial is exploring whether adding everolimus can help patients who continue to have high levels of the virus after reducing their immunosuppressive drugs.

To be eligible for the trial, participants must be at least 18 years old and have had a kidney transplant at King Chulalongkorn Memorial Hospital. They should have persistent high levels of the BK virus in their blood, specifically more than 1,000 copies/mL on multiple tests. However, those with extremely high virus levels or a history of specific treatments for BK virus will not be able to participate. If you join the trial, you will receive careful monitoring and support throughout the study. This research could help find better ways to manage BK virus infections, ultimately improving the health of kidney transplant recipients.

Gender

ALL

Eligibility 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

About King Chulalongkorn Memorial Hospital

King Chulalongkorn Memorial Hospital, a leading medical institution in Thailand, is renowned for its commitment to advancing healthcare through innovative research and clinical trials. Affiliated with Chulalongkorn University, the hospital integrates cutting-edge medical practices with a robust academic framework, fostering an environment conducive to pioneering clinical studies. With a focus on improving patient outcomes and contributing to global medical knowledge, the hospital engages in a diverse range of clinical trials across various therapeutic areas, ensuring adherence to the highest ethical standards and regulatory guidelines. Through collaboration with healthcare professionals and researchers, King Chulalongkorn Memorial Hospital aims to enhance the quality of care while driving forward the frontiers of medical science.

Locations

Bangkok, , Thailand

Patients applied

0 patients applied

Trial Officials

Suwasin Udomkarnjananun, MD, MSc

Principal Investigator

Chulalongkorn University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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