This is a multiple-center, prospective, open-label, positive drug controlled, randomized, clinical study to evaluate the safety and efficacy of Telitacicept in the treatment of primary membranous nephropathy.
The study consists of four stages as follows: 1. Screening period (0-6 months): After signing the informed consent form, subjects enter the screening period. 2. Induction treatment period (3 months): Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks), and cyclophosphamide is administrated intravenously at a dose of 0.4 g/d twice a month. 3. Group treatment period (6 months): Patients who complete the induction treatment period undergo an efficacy assessment to determine whether they achieve a complete remission or partial remission. Patients who do not achieve a complete remission or partial remission are defined as non-responders. Patients who achieve a complete remission or partial remission are randomized and enter the group A or group B. Patients of non-responders are randomized and enter the group C and group D. Patients in group A and C continue the initial treatment regimen for 6 months. Patients in group B and D commence hypodermic injection of Telitacicept 160 mg weekly 6 months with the continued administration of prednisone and cyclophosphamide in group D while discontinued cyclophosphamide administration in group B. 4. Follow-up period (12 months): After completing 6 months of group treatment, cyclophosphamide or Telitacicept is discontinued with minimal dose of 5mg/d prednisone remained. All the patients are subjected to a 12-month follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
172
Subcutaneous injection of 160 mg is administered once a week.
Induction therapy period (3 months):Eligible subjects receive induction treatment with Methylprednisone 0.5 g i. v. for 3 consecutive day and followed by orally administration of prednisone at an initial dose of 0.8 mg/kg/day, tapered gradually after 2 months (reduced by 5 mg every 2 weeks) Grouped treatment period (6 months): The maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation.
An intravenous injection of 0.4 g is administered twice a month.
Renmin Hospital of Wuhan university
Wuhan, Hubei China, China
Complete remission rate at the end of follow-up (21 months post-treatment)
Complete remission defined as 24h urine protein quantification ≤0.3g/24h.
Time frame: 21 months
Partial remission rate at the end of follow-up (21 months post-treatment)
Partial remission defined as 24h proteinuria quantification \<3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or \<30% increase from baseline value.
Time frame: 21 months
Incidence of relapse of nephrotic syndrome at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Recurrence of proteinuria \>3.5 g/24h or at least a ≥50% increase from the nadir was defined as recurrence of nephrotic syndrome in patients who had achieved partial or complete remission.
Time frame: 3-21 months
Incidence of adverse events in each group
This trial specifies that the recording of adverse events shall be recorded as a medical history from the time the subject receives the induction phase treatment administration, and from the time of signing the informed consent form until the clinical diagnosis, abnormal signs and symptoms, and examination findings occurring prior to the administration of the induction phase treatment.
Time frame: 0-21 months
Complete remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Complete remission defined as 24h urine protein quantification ≤0.3g/24h.
Time frame: 3-21 months
Partial remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment
Partial remission defined as 24h proteinuria quantification \<3.5g/24h or ≥50% reduction from baseline and stable serum creatinine or \<30% increase from baseline value.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 3-21 months