drugset / Trial / NCT03418779
Treatment Effects of Chinese Medicine (Yi-Qi-Qing-Jie Herbal Compound) Combined With Immunosuppression Therapies in IgA Nephropathy Patients With High-risk of ESRD
Phase 2/3
Active not recruiting
60 enrolled
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
China Academy of Chinese Medical Sciences · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The TCM-WINE study is a single-center, prospective, double-blind randomized placebo-controlled trial. Based on optimal supportive care, the trial is aiming to assess superiority with regard to renal protection and reduction of severe treatment-related adverse events of Yi-Qi-Qing-Jie formula (YQF) combined therapy compared with immunosuppression monotherapy in high-risk IgAN.
Timeline
- Start
- 2019-07-04
- Primary completion
- 2024-09-25
- Completion
- 2024-12-31
Publications
- Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.
- Li S, Li JP. Treatment effects of Chinese medicine (Yi-Qi-Qing-Jie herbal compound) combined with immunosuppression therapies in IgA nephropathy patients with high-risk of end-stage renal disease (TCM-WINE): study protocol for a randomized controlled trial. Trials. 2020 Jan 6;21(1):31. doi: 10.1186/s13063-019-3989-9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Yi-Qi-Qing-Jie herbal compound | Traditional medicine (herbal / TCM) | — | Oral |
| Background | Cyclophosphamide | Other / unclassified | 0.8 g | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | 1 g | Intravenous |
| Background | Prednisolone | Other / unclassified | 0.5 mg/kg | Oral |
| Background | Prednisolone | Other / unclassified | 0.8 mg/kg | Oral |