NCT05293704

An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Lee's Pharmaceutical Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. All patients who met the inclusion criteria were treated with mizoribine to place MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) for 12 months as directed. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.

Detailed description

This study is divided into two parts: ① Part I was a retrospective observational study. Kidney transplant recipients infected with BK virus (BKV) in the First Affiliated Hospital of Sun Yat-sen University from 2015 to 2021 were retrospectively collected and divided into case group and control group whether to convert MPA drug to mizoribine. The basic data of the two groups, the concentration of mizoribine, the clinical benefit after conversion and the outcome of BKV infection were analyzed, and the clinical improvement rate and preliminary safety of mizoribine conversion on BKV infection were determined. ② The second part was a prospective, open and interventional clinical trial. Thirty patients with positive urinary BK virus after kidney transplantation using Mycophenolic acid (MPA) were enrolled in the First Affiliated Hospital of Sun Yat-sen University. The patients and their families voluntarily participated in the experiment and signed the Informed Consent on the premise of fully understanding the treatment plan. The treatment was approved by the hospital ethics Committee. All patients who met the inclusion criteria were treated with MPA (Mycophenolate or mycophenolate sodium enteric coated tablets) replaced with mizoribine for 12 months. At the baseline of follow-up (before enrollment) and at each follow-up point, clinical indicators of patients were recorded, and renal biopsy was performed to evaluate the occurrence of BKV nephropathy in patients with persistent elevated BK viruria or persistent BK viremia after conversion and patients with BK viruria after 12 months, and to judge the progress after early activation of BKV and the safety of mizoribine.

Conditions

• Kidney Transplant Recipients
• BK Virus

Interventions

Type	Name	Description
DRUG	Mizoribine	Orally administered at 3-4 mg/kg/d, once every 12 hours; When body weight ≤50 kg, each dose of 75 mg; Weight \& gt At 50 kg, the dosage was 100 mg each time.

Timeline

• Start date: 2022-05-01
• Primary completion: 2023-12-01
• Completion: 2024-05-01
• First posted: 2022-03-24
• Last updated: 2022-03-24

Locations

1 site across 1 country: China