To confirm the efficacy and safety of rituximab (genetical recombination) intravenously administered to idiopathic membranous nephropathy with nephrotic syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
88
Administer 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses in double-blind phase.
Administer placebo IV infusion every two weeks for two doses in double-blind phase.
Patients who remain to be ICR II (Incomplete Remission Type II) or NR (No Response) until Week 26 in the double-blind phase, if the patients wish to move to the open-label phase and the investigator or a subinvestigator considers the move necessary, the patient will move to the open-label phase and receive 1,000 mg of rituximab (genetical recombination) IV infusion every two weeks for two doses after the readministration criteria are confirmed to be met.
Anjo Kosei Hospital
Anjo, Aichi-ken, Japan
Kasugai Municipal Hospital
Kasugai, Aichi-ken, Japan
Percentage of patients achieving ICR I
Achieving ICR I is defined as "Urine protein-creatinine ratio \< 1.0 g/gCr".
Time frame: up to 26 weeks
Percentage of patients who are CR, ICR I, ICR II, NR or PR
CR, ICR I, ICR II, NR or PR are defied as below; CR (Complete Remission): Urine protein-creatinine ratio \< 0.3 g/gCr ICR I (Incomplete Remission Type I): 0.3 g/gCr ≤ Urine protein-creatinine ratio \< 1.0 g/gCr ICR II (Incomplete Remission Type II): 1.0 g/gCr ≤ Urine protein-creatinine ratio \< 3.5 g/gCr NR (No Response): 3.5 g/gCr ≤ Urine protein-creatinine ratio PR (Partial Remission): Decrease in urine protein-creatinine ratio from base line ≥50%, and urine protein-creatinine ratio 0.3 to 3.5 g/gCr
Time frame: up to 26 weeks
Duration before achieving CR, ICR I, ICR II or PR
Duration of achieving CR, ICR I, ICR II or PR is summarized.
Time frame: up to 26 weeks
Urine protein-creatinine ratio
The differences of urine protein-creatinine ratio between prior to treatment and at each timepoint are summarized.
Time frame: up to 26 weeks
eGFR
The differences of eGFR between prior to treatment and at each timepoint are summarized.
Time frame: up to 26 weeks
B-cells (CD19-positive and CD20-positive cells)
B cell counts (CD19 positive and CD20 positive cell counts) at each timepoint are summarized.
Time frame: up to 26 weeks
Expression of HACA
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Konan Kosei Hospital
Kōnan, Aichi-ken, Japan
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
Fujita Health University hospital
Toyoake, Aichi-ken, Japan
Juntendo University Urayasu Hospital
Urayasu, Chiba, Japan
Kyushu University Hospital
Fukuoka, Fukuoka, Japan
Kurume University Hospial
Kurume, Fukuoka, Japan
Asahikawa Medical University Hospital
Asahikawa, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
...and 8 more locations
The number of patients expressing HACA, and the proportion of these patients at each timepoint are summarized.
Time frame: up to 26 weeks
Serum rituximab (genetical recombination) concentration
Serum rituximab (genetical recombination) level at each timepoint are summarized.
Time frame: up to 26 weeks