NCT05847920TerminatedPhase 2
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
Source: ClinicalTrials.gov · Last updated 5 Mar 2025
Reason given: Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.
Brief summary (registry, in English)
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
- Status (registry)
- Terminated
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 53 (actual)
- First submitted
- 27 Apr 2023
- Start date
- 4 Jun 2023
- Primary completion date
- 20 Jan 2025
- Lead sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
- Diseases
- IgA nephropathy
- NCT number
- NCT05847920
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- A history of chronic or recurrent infection within 1 year prior to screening
- Subjects who have received organ transplants
- Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
- Received any systemic glucocorticoid 8 weeks before screening or during run-in period
Other illness
- systemic disease which may cause secondary IgA deposition in the mesangial region
- History of severe opportunistic infection
- History of active digestive system within one year
- Have a malignant tumor or a history of malignant tumor
- Associated with other serious or poorly controlled systemic diseases
- Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
Other
- Specific type of IgA nephropathy
Who the study is looking for
- Able and willing to provide a written informed consent
- Renal biopsy confirmed primary IgA nephropathy
- 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
- eGFR≥30 mL/min/ 1.73m2
- 40kg≤ Weight ≤100kg
- Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| General Hospital of Eastern Theater Command | Nanjing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.