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Clinical outcomes of abatacept in patients with refractory lupus nephritis: Phase II study

Clinical outcomes of abatacept in patients with refractory lupus nephritis: Phase II study

Status
Active, not recruiting
Phases
Phase 2
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400081359
Enrollment
Unknown
Registered
2024-02-29
Start date
2021-01-01
Completion date
Unknown
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lupus nephritis

Interventions

treatment group:Abatacept 125mg/week subcutaneously

Sponsors

Renji Hospital, Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients with lupus nephritis (LN) on abatacept with a diagnosis that meets the criteria for the diagnostic classification of systemic lupus erythematosus (SLE) published jointly by the European League Against Rheumatic Diseases (EULAR) and the American College of Rheumatology (ACR) in 2019, seen at Renji Hospital. (2) Age >16 years. (3) Renal biopsy within 2 years showed lupus nephritis type III, IV, V (alone or in combination with III or IV). (4) 24h urine protein >1g (5)anti-dsDNA= 77 IU/mL (ELISA) or = 20 IU/mL (Farr) or complement C3 25% decrease in estimated glomerular filtration rate [eGFR] from baseline)

Exclusion criteria

Exclusion criteria: (1) Pregnant or lactating women (2) eGFR < 25 ml/minute/1.73 m2 (3) Active infections such as Mycobacterium avium subspecies, presence of hepatitis B surface antigen or hepatitis C antibodies in the blood, evidence of HIV positivity, etc. (4) No treatment with small molecule biologics (e.g., belimumab, rituximab) within 12 weeks prior to enrolment. (5) Have had a malignant tumour within 5 years.(Except for melanoma) (6) Organ transplant recipients (7) Any medical condition during the study period that may interfere with study conduct, interpretation, or patient safety

Design outcomes

Primary

MeasureTime frame
eGFR;24-hour proteinuria;creatinine;

Secondary

MeasureTime frame
SLEDAI-2K;SLE-DAS;

Countries

China

Contacts

Public ContactLiangjing Lu

Renji Hospital, Shanghai Jiao Tong University School of Medicine

lu_liangjing@163.com+86 136 6147 2001

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026