A Phase 2 interventional study of Telitacicept and Prednisone in Primary Membranous Nephropathy, sponsored by Renmin Hospital of Wuhan University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-26.
Sponsored by Renmin Hospital of Wuhan University · Phase 2, Interventional, and Treatment
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:
Renmin Hospital of Wuhan University is the lead sponsor of 85 studies on the registry; 28 are open to participants now.
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Exclusion Criteria:
After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Patients who have achieved complete or partial remission are then randomly assigned to either Group A or Group B at a 1:1 ratio. Medication regimen of Group A： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.
Drug: Prednisone · Drug: Cyclophosphamide
Medication regimen of Group B： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.
Drug: Telitacicept · Drug: Prednisone
After completing the induction treatment period, patients undergo an efficacy evaluation to determine if complete remission or partial remission has been achieved. Patients who have not achieved complete or partial remission are classified as non-responders. Non-responders are randomly assigned to either Group C or Group D at a 1:1 ratio. Medication regimen of Group C： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Cyclophosphamide injection：an intravenous injection of 0.4 g is administered twice a month.
Drug: Prednisone · Drug: Cyclophosphamide
Medication regimen of Group D： Prednisone：the maintenance induction treatment regimen is continued, with regular tapering (reducing by 5 mg every 2 weeks) until discontinuation； Telitacicept injection：an intravenous injection of 0.4 g is administered twice a month.
Drug: Telitacicept · Drug: Prednisone · Drug: Cyclophosphamide
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.
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.
Time frame: 3-21 months
Plan to share: Undecided
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This study is not yet recruiting, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Telitacicept · Cyclophosphamide
Renmin Hospital of Wuhan University