The Efficacy and Safety of Treatment With Telitacicept in Primary Membranous Nephropathy

NCT06614985 | Not Yet Recruiting Phase 2

• 1 other identifier: Huiming Wang
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Primary Membranous Nephropathy

Outcome Measures

Primary Outcomes (2)

• Complete remission rate at the end of follow-up (21 months post-treatment)

  Complete remission defined as 24h urine protein quantification ≤0.3g/24h.

  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.

  21 months

Secondary Outcomes (4)

• Incidence of relapse of nephrotic syndrome at months 3, 6, 9, 12, 15, 18, and 21 after treatment

  3-21 months

• Incidence of adverse events in each group

  0-21 months

• Complete remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment

  3-21 months

• Partial remission rate at months 3, 6, 9, 12, 15, 18, and 21 after treatment

  3-21 months

Study Arms (4)

Group A

ACTIVE COMPARATOR

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

Group B

EXPERIMENTAL

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

Group C

ACTIVE COMPARATOR

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

Group D

EXPERIMENTAL

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

Interventions

Telitacicept DRUG

Subcutaneous injection of 160 mg is administered once a week.

Group B; Group D

Prednisone DRUG

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.

Group A; Group B; Group C; Group D

Cyclophosphamide DRUG

An intravenous injection of 0.4 g is administered twice a month.

Group A; Group C; Group D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants are required to consent to use effective contraception methods with their partners throughout the entire duration of the study. Participants must have a thorough understanding of the nature, significance, potential benefits, inconveniences, and potential risks of the study and voluntarily sign an informed consent form.

You may not qualify if:

• Secondary membranous nephropathy patients (caused by autoimmune or infectious diseases, tumors, etc.);
• Patients with HIV infection, viral hepatitis, active liver disease (with ALT/AST/bilirubin levels exceeding 3 times the upper limit of normal), or other severe infections;
• Patients with a rapid decline in eGFR (\>15 mL/min) during the screening period are excluded;
• Patients who have undergone kidney transplantation or other organ transplantation;
• Patients with a known allergy or hypersensitivity to the active ingredient of the investigational drug or any of the listed excipients;
• Patients with acute or critical cardiovascular or cerebrovascular diseases;
• Patients with immunodeficiency, hypoalbuminemia (IgG \< 400 mg/dl), or IgA deficiency (IgA \< 10 mg/dL);
• Pregnant or lactating women;
• Patients diagnosed with malignant tumors within the past 5 years;
• Laboratory findings of severe abnormalities (Hb \< 80 g/L, PLT \< 50,000/mm3, neutrophil count \< 1,000/mm3, etc.);
• Patients who have used steroids or immunosuppressive agents (including but not limited to corticosteroids, adrenocorticotropic hormones, azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine, biologic agents such as rituximab, etc.), cyclophosphamide, bortezomib, dexamethasone, Chinese medicines or preparations containing Tripterygium wilfordii, intravenous immunoglobulin, plasma exchange, leukapheresis, live vaccines, or other investigational drugs, etc., within 3 months prior to screening;
• Patients with other diseases or conditions that, in the opinion of the investigator, would render the patient unsuitable for participation in this study;

Sponsors & Collaborators

• Renmin Hospital of Wuhan University: lead

Study Sites (1)

Renmin Hospital of Wuhan university

Wuhan, Hubei China, 430075, China

Location

MeSH Terms

Interventions

telitacicept; Prednisone; Cyclophosphamide

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Central Study Contacts

Huiming Wang, PhD

CONTACT

+86 18971563100; rm000301@whu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Department of Nephrology

Model Details: 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. Non-responders are also randomly assigned to either Group C or Group D at a 1:1 ratio. Treatment administration is subsequently carried out based on group assignment.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: September 26, 2024
• Study Start: October 20, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: September 26, 2024

Record last verified: 2024-09

Locations

CN (1)