A double-blind,placebo controlled,randomized Phase 2 study to evaluate the safety and tolerability of once-daily, oral administration of 200 or 300 mg HSK39297 tablets versus placebo in Patients With Lupus Nephritis
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
105
once daily, oral administration of HSK39297 tablets 200mg from Day 1 to Week 52.
once daily, oral administration of HSK39297 tablets 300mg from Day 1 to Week 52.
once daily, oral administration of placebo from Day 1 to Week 52.
Institute of Nephrology, Zhong Da Hospital, Southeast University School of Medicine
Nanjing, Jiangsu, China
RECRUITINGRatio of 24h-UPCR compared to Baseline
Urine Protein Creatinine Ratio
Time frame: 24 weeks
Proportion achieving CRR/PRR
Complete Renal Response,Partial Renal Response
Time frame: 12,24,52 weeks
Proportion achieving CRR/PRR without renal recurrence
Complete Renal Response,Partial Renal Response
Time frame: 24,52 weeks
Proportion achieving CRR/PRR with glucocorticoid ≤ 5mg/d
Complete Renal Response,Partial Renal Response
Time frame: 24,52weeks
Proportion achieving 25%/50% reduction in 24h-UPCR
Urine Protein Creatinine Ratio
Time frame: 12,24,52 weeks
Time to first achievement of CRR, 25%/50% proteinuria reduction
Complete Renal Response
Time frame: from baseline to 52 weeks
Duration of sustained CRR/PRR
Complete Renal Response,Partial Renal Response
Time frame: from baseline to 52 weeks
Change in 24h-UPCR from baseline.
Urine Protein Creatinine Ratio
Time frame: from baseline to 52 weeks
Change in eGFR from baseline
Estimated glomerular filtration rate
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Time frame: 12,24,52 weeks
Proportion with Glucocorticoid dose ≤ 5mg/d
Time frame: 24,52 weeks
Annualized slope of eGFR
Estimated glomerular filtration rate
Time frame: 52 weeks
Change in SLEDAI-2000 (Systemic lupus erythematosus disease activity index 2000,SLEDAI-2000)total score from baseline
SLEDAI-2000 scale ranges form 0 to 105 score. The higher scores indicate a higher disease activity level of the subject's systemic lupus erythematosus .
Time frame: 12, 24, 52 weeks
Incidence and severity of adverse events (AEs)
Time frame: 52 weeks
Pharmacokinetic characteristics(Cmax) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Cmin) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Cavg) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(Tmax) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Pharmacokinetic characteristics(AUC0-τ) of HSK39297 tablets in plasma.
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(Ap)
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(Bb)
Time frame: 52 weeks
Changes from baseline of pharmacodynamic indicators(sC5b-9)
Time frame: 52 weeks
Changes from baseline in biological markers (C3)reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Changes from baseline in biological markers (C4)reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Changes from baseline in biological markers (anti-dsDNA antibody)reflecting immunological activity of lupus nephritis
Time frame: 52 weeks
Change in FACIT-F (Functional Assessment of Chronic Illness Therapy-Fatigue)score from baseline
FACIT-F scale ranges from 0 to 52 score,and the higher scores indicate a better condition of the subject and less fatigue.
Time frame: 52 weeks