CLINICAL TRIALS PROFILE FOR MIZORIBINE
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Clinical Trials for Mizoribine
| Trial ID | Title | Status | Sponsor | Phase | Summary |
|---|---|---|---|---|---|
| NCT02005757 ↗ | Efficacy and Safety Study of Mizoribine in Active Rheumatoid (AMOLED) | Unknown status | Chong Kun Dang Pharmaceutical | Phase 2 | The purpose of this study is to access the efficacy and safety of Mizoribine 150mg qid and 50mg tid in active rheumatoid arthritis patients unsuccessfully treated with disease-modifying antirheumatic drug. |
| NCT02256150 ↗ | A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Lupus Nephritis | Completed | Asahi Kasei Pharma Corporation | Phase 3 | To demonstrate that the treatment effect in lupus nephritis of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment. |
| NCT02257697 ↗ | A Study to Evaluate the Efficacy and Safety of Mizoribine in the Treatment of Refractory Nephrotic Syndrome | Completed | Asahi Kasei Pharma Corporation | Phase 3 | To demonstrate that the treatment effect in refractory nephrotic syndrome of MZR is non-inferior to that of standard therapy CTX through analyzing overall remission rate after treatment. |
| NCT02373202 ↗ | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) | Completed | Regeneron Pharmaceuticals | Phase 3 | Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy. |
| NCT02373202 ↗ | A Study Assessing the Safety and Efficacy of Sarilumab Added to Non-MTX DMARDs or as Monotherapy in Japanese Patients With Active Rheumatoid Arthritis (SARIL-RA-HARUKA) | Completed | Sanofi | Phase 3 | Primary Objective: To document the long-term safety of sarilumab added to non-methotrexate (non-MTX) disease-modifying antirheumatic drugs (DMARDs) or as monotherapy. Secondary Objective: To document the long term efficacy of sarilumab added to non-MTX DMARDs or as monotherapy. |
| NCT05293704 ↗ | An Open Study on the Preventive Effect of Early Mizoribine Conversion on BKV Nephropathy in Renal Transplant Recipients | Not yet recruiting | Lee's Pharmaceutical Limited | Phase 4 | 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. |
| NCT06114953 ↗ | Comparative Efficacy of Mizoribine With Mycophenolate Mofetil for Living Related Kidney Transplantation Recipients | Recruiting | Lee's Pharmaceutical Limited | Phase 4 | This prospective, randomized controlled study is intended to enroll 152 patients in the early stages of donor kidney transplantation at six clinical centers in China between January 2023 and January 2024. All patients meeting the inclusion criteria were randomly assigned 1:1 to either Mizoribine or Mycophenolate Mofetil for 12 months. At the baseline of follow-up (before enrollment) and each follow-up point, all clinical indicators of patients were recorded to measure the therapeutic effect. |
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