The objective of this study is to evaluate the efficacy and safety of Tacrolimus capsules for induction remission in patients with lupus nephritis, and compare the efficacy and safety with Cyclophosphamide injections.
This is a randomized, open, 1:1 parallel controlled, multi-center, non-inferiority clinical study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
314
Site CN00043
Remission rate (complete remission + partial remission)
complete remission: urine protein \< 0.5g/24hr, and serum albumin≥3.5g/dl, and stable renal function (Scr increase ≤ 15% baseline value) partial remission: urine protein 0.5-3.5g/24hr (≥ 0.5 g/24hr and \< 3.5 g/24hr), and urine protein decreased by \>50% comparing with the baseline, and serum albumin ≥ 3.0g/dl, and stable renal function (Scr increase ≤ 15% baseline value)
Time frame: at 24 weeks
24-hour urine protein
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of 24-hour urine protein from baseline
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Serum albumin
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of Serum albumin from baseline
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Serum creatinine
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Change of Serum creatinine from baseline
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
eGFR comparing with baseline
eGFR: Estimated Glomerular Filtration Rate
Time frame: at Day 1, Weeks 1, 2, 4, 8, 12, 16, 20, 24
Percentage of patients converted to other immunosuppressive therapy
Time frame: during 24 weeks
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Hefei, Anhui, China
Site CN00030
Beijing, Beijing Municipality, China
Site CN00034
Beijing, Beijing Municipality, China
Site CN00041
Xiamen, Fujian, China
Site CN00056
Guangzhou, Guangdong, China
Site CN00017
Shenzhen, Guangdong, China
Site CN00045
Liuzhou, Guangxi, China
Site CN00037
Nanning, Guangxi, China
Site CN00038
Nanning, Guangxi, China
Site CN00020
Shijiazhuang, Hebei, China
...and 25 more locations
Percentage of patients with serum creatinine rising to two times of the baseline
Time frame: during 24 weeks
Percentage of patients with dsDNA and ANA converting from positive to negative
ANA: Antinuclear Antibody
Time frame: during 24 weeks
SLE-DAI
SLE-DAI: Systemic Lupus Erythematosus - Disease Activity Index
Time frame: at Week 4, 12 and 24
Immune parameters assessed by ESR, C3, C4 and dsDNA
ESR: Erythrocyte Sedimentation Rate, C3, C4: Complement C3, C4, dsDNA: Anti-Double-Stranded DNA Antibodies
Time frame: at Week 4, 12 and 24
Change of SLE-DAI from baseline
Time frame: at Week 4, 12 and 24
Change of immune parameters from baseline
Time frame: at Week 4, 12 and 24
Renal biopsy AI (Active Index)
Time frame: at Week 24
CI (Chronic Index)
Time frame: at Week 24
Change of Renal biopsy AI (Active Index) from baseline
Time frame: at Week 24
Change of CI (Chronic Index) from baseline
Time frame: at Week 24