ANCA-Associated Glomerulonephritis, Lupus Nephritis (LN)
Conditions
Keywords
MSC303, Immune glomerular diseases
Brief summary
This study will evaluate the safety and efficacy of MSC303 in patients with Immune glomerular diseases.
Detailed description
The primary endpoint of Phase Ib：Evaluate the safety of MSC303 in patients with Lupus Nephritis (LN）and ANCA-associated glomerulonephritis (ANCA-GN). The primary endpoint of Phase II：Evaluate the change of Urine Protein/Creatinine Ratio (UPCR) in Week 12 compared with the baseline of MSC303 in patients with Lupus Nephritis(LN） and ANCA-associated glomerulonephritis (ANCA-GN).
Interventions
DRUGInjection of MSC303
Dose Group 1: D1, D8, D15, and D36 were respectively given 1, 5, 15, and 15 mg of MSC303 for injection; The second dose group: D1, D8, D15 and D36 were respectively given for injection MSC303 1, 5, 20, 20 mg.
Sponsors
Shanghai Changzheng Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 18 to 65 years (including boundary values), gender unspecified； 2. Willing to participate voluntarily in this clinical study and with good compliance； 3. Regarding the criteria for the study diseases, meet the diagnostic criteria for any of the following diseases: 1. Diagnosed with lupus nephritis(LN); 2. diagnosed with ANCA-associated glomerulonephritis (ANCA-GN); 4. Sufficient organ function;
Exclusion criteria
1. History of severe allergic reaction to humanized monoclonal antibodies, or known allergy to any component of MSC303； 2. Active infection requiring antibiotic treatment； 3. Concomitant with other serious diseases； 4. Patients with congenital immunoglobulin deficiency； 5. Infection with human immunodeficiency virus (Human immunodeficiency virus (HIV)), hepatitis B or hepatitis C (including HBsAg, HBcAb positive with abnormal Hepatitis B Virus DNA (HBV DNA) or Hepatitis C virus RNA (HCV RNA )); 6. Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Phase Ib: safety Phase II: Urine Protein/Creatinine Ratio (UPCR) | 12 week | Phase Ib: To evaluate the safety of MSC303 for injection in subjects with immune glomerular diseases. Phase II: To evaluate the change in Urine Protein/Creatinine Ratio (UPCR) from baseline at Week 12. |
Countries
China
Contacts
Primary ContactHuji Xu, Ph.D, MD
Outcome results
None listed