Status:
UNKNOWN
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
Lead Sponsor:
Lee's Pharmaceutical Limited
Conditions:
Kidney Transplant Recipients
BK Virus
Eligibility:
All Genders
18+ years
Phase:
PHASE4
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 Univer...
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 Univer...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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;
- Other competent physicians judged that the recipients were not suitable for inclusion.
Key Trial Info
Start Date :
May 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05293704
Start Date
May 1 2022
End Date
May 1 2024
Last Update
March 24 2022
Active Locations (1)
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1
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou, China