Lupus Nephritis
Conditions
Brief summary
This is a prospective single-arm multi-center trial to evaluate the efficacy and safety of O-triple regimen in initial active LN patients
Interventions
Patients will receive Obinutuzumab 1000 mg at day1 (week 0) and weeks 2, 24, 26, and 52, in combination with glucocorticoids and MMF.
Sponsors
Zhao Minghui
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. Signed Informed Consent Form 2. Age 18 to 65 years at time of signing Informed Consent Form 3. Ability to comply with the study protocol, in the investigator's judgment 4. ISN/RPS 2003 Class III, IV, V active/active chronic LN by renal biopsy performed within the 1 month prior to screening or during screening with 24hUPCR≥1g/g 5. SLE according to the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) Classification Criteria, which are met by the presence of Class III- V LN or mixed Class LN, and current or past positive antinuclear antibody (ANA) Positive ANA is defined by ANA at a titer of ≥ 1:80 on HEp-2 cells or an equivalent positive ANA test at least once. 6. Receipt of at least one dose of pulse methylprednisolone IV (≥250 mg) or equivalent for treatment of the current episode of active LN during the 1 month prior to screening or during screening 7. A maximum of 3 g methylprednisolone IV or equivalent d during the 4 weeks prior to screening or during screening is allowed.
Exclusion criteria
： 1. Are pregnant or breastfeeding. 2. Have severe renal impairment, defined as eGFR \< 30 mL/min/1.73 m² (estimated using the CKD-EPI equation), or require dialysis or renal transplantation. 3. Have renal biopsy showing \> 50% glomerular sclerosis. 4. Have pure chronic renal biopsy findings: no active lesions. 5. Have rapidly progressive glomerulonephritis. 6. Have active gastrointestinal ulcer. 7. Have intolerance or contraindication to the study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who achieve a complete renal response (CRR) at Week 76 | Baseline, Week 76 | Urinary protein-to-creatinine ratio (UPCR) \<0.5 g/g eGFR ≥ 85% of baseline, as calculated using the CKD-EPI equation No occurrence of intercurrent events (rescue therapy, treatment failure, and early study withdrawal are considered as intercurrent events). |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients who achieve ORR (CRR or PRR), CRR, PRR, PERR at week 24, week 36, week 52, week 76 | Baseline week 24, week 36, week 52, week 76 |
Countries
China
Contacts
CONTACTMinghui Zhao
Outcome results
None listed