Condition: Membranous Nephropathy · Lupus Nephritis (LN) · Sponsor: Shanghai Henlius Biotech
The primary objectives of this clinical trial is to evaluate the safety and tolerability of HLX79 in combination with HLX01 versus placebo in combination with HLX01 in the treatment of glomerulonephritis. The secondary objective are to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of HLX79 and HLX01, the clinical efficacy, the dynamic changes of biomarkers of HLX79 in combination with HLX01 in the treatment of glomerulonephritis. The subjects will receive different doses of HLX79 (10, 20, or 30 mg/kg) or placebo, all in combination with HLX01. After the end of the first treatment period, subjects will enter a 20-week follow-up period and then undergo pre-second treatment period assessments. If the investigator determines that the subject does not require the second treatment period, the subject will continue in follow-up until completing the total 48-week follow-up period.
This description comes directly from the study's public registry record.
Qi Jin · +86-15955160489 · qi_jin@henlius.com
Always discuss trial participation with your own doctor first.
| Beijing Tsinghua Changgung Hospital | Beijing, China | Not Yet Recruiting |
| Peking University People's Hospital | Beijing, China | Not Yet Recruiting |
| Xiangya Hospital Of Gentral South University | Changsha, China | Not Yet Recruiting |
| Guangdong Provincial People's Hospital | Guangzhou, China | Not Yet Recruiting |
| Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou, China | Not Yet Recruiting |
| The First Affiliated Hospital Zhejiang University School Of Medicine | Hangzhou, China | Not Yet Recruiting |
| The Second Hospital of Anhui Medical University | Hefei, China | Not Yet Recruiting |
| The First Affiliated Hospital of Henan University of Science and Technology | Luoyang, China | Not Yet Recruiting |
| Jiangxi Provincial People's Hospital | Nanchang, China | Not Yet Recruiting |
| The First Affiliated Hospital of Nanchang University | Nanchang, China | Not Yet Recruiting |
| Jiangsu Province Hospital | Nanjing, China | Not Yet Recruiting |
| Zhongdong Hospital Southeast University | Nanjing, China | Not Yet Recruiting |
+ 5 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07038382