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NCT05293704
An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients
Phase 4 trial testing Mizoribine in Kidney Transplant Recipients in 30 participants. Status unknown.
1 December 2023
Quick facts
| Lead sponsor | Lee's Pharmaceutical Limited |
|---|---|
| Phase | Phase 4 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 1 May 2022 |
| Primary completion | 1 December 2023 |
| Estimated completion | 1 May 2024 |
| Sites | 1 location across China |
Drugs / interventions tested
- Mizoribine (MIZORIBINE) — full drug profile →
Conditions studied
- Kidney Transplant Recipients — all drugs for Kidney Transplant Recipients →
- BK Virus — all drugs for BK Virus →
Sponsor
Lee's Pharmaceutical Limited — full company profile →
Who can join
18 and older, any sex, with Kidney Transplant Recipients or BK Virus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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. 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05293704 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Lee's Pharmaceutical Limited
- Last refreshed: 24 March 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05293704.
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