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

NCT05293704 | Unknown Phase 4

• 1 other identifier: BLDN-LEES-2022-3
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Kidney Transplant Recipients; BK Virus

Outcome Measures

Primary Outcomes (1)

• Number of Participants who had BKV-related nephropathy occurred

  During the follow-up, patients with urinary BKV-DNA increase of more than 10 times for 3 consecutive months after dressing change, or viremia (serum BKV-DNA load ≥10\^4/ mL) for 3 consecutive months after dressing change, as well as patients with urinary BKV positive 12 months after dressing change, were evaluated by renal biopsy pathology. The number of Participants who had BKV-related nephropathy occurred will be counted.（BKV stands for BK polyoma virus）

  12 month

Secondary Outcomes (3)

• Number of Participants in who Serum and urine BK viral load were cleared

  12 month

• Number of Participants with Acute rejection

  12 month

• Number of Participants with Renal graft loss

  12 month

Interventions

Mizoribine DRUG

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Kidney transplant recipients;
• Postoperative maintenance therapy with glucocorticoid + tacrolimus +MPA;
• Urinary BKV-DNA load ≥10\^7/L;
• No gender limitation for recipients \> 18 years of age;
• Voluntarily sign written informed consent.

You may not qualify if:

• Multiple organ transplantation;
• Acute rejection occurred within 1 week before enrollment;
• Recipients with signs of active infection;
• Recipients with white blood cell count below 3,000 /cubic metre;
• Women who are pregnant, breast-feeding, or unwilling to use appropriate contraceptive methods during the study period;
• Patients with serious gastrointestinal diseases and active peptic ulcer disease;
• Suffering from any mental illness;
• Patients with severe heart disease and abnormal cardiac function;
• Subjects with known allergy to the test drug;

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

Location

MeSH Terms

Interventions

mizoribine

Central Study Contacts

Yang huan

CONTACT

15626450204; huan.yang@leespharm.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2022
• First Posted: March 24, 2022
• Study Start: May 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: May 1, 2024
• Last Updated: March 24, 2022

Record last verified: 2022-03

Locations

CN (1)