Study of Telitacicept in Patients With Refractory IgA Nephropathy

A Single-arm, Forward-looking, Exploratory Clinical Study of Telitacicept in Patients With Refractory IgA Nephropathy

The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy.

The main questions it aims to answer are:

• To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy.
• To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy.

Participants will be subcutaneously injected with 240mg of Telitacicept once per week.

Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.

Study Overview

• Status: Not yet recruiting
• Conditions: IgA Nephropathy
• Intervention / Treatment: Drug: Telitacicept

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • The Second Affiliated Hospital of Zhejiang University School of Medicine
      • Contact: Ma Kunling, PhD; Phone Number: 15150515798; Email: klma@zju.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Voluntarily sign the informed consent form.
2. IgA nephropathy was confirmed by pathological biopsy.
3. Age range: ≥ 18 years old, ≤ 70 years old, male or female.
4. During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
5. Measured glomerular filtration rate or estimated GFR (using the CKD-EPI formula) > 35 mL/min/1.73 m2.
6. Participants had received a basic regimen including ACE inhibitors/ARBs for 12 weeks prior to randomization, and the dose of ACE inhibitors/ARBs (within the maximum tolerated range) was stable for 4 weeks prior to randomization.

Exclusion Criteria:

1. Abnormal laboratory indicators of participants need to be excluded.
2. Secondary IgA nephropathy need to be excluded.
3. Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
4. Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
5. Use of systemic corticosteroids within 3 months prior to randomization (except local, nasal inhalation, etc.)
6. Immunosuppressants were used within 3 months prior to randomization.
7. Patients requiring hospitalization for active infection or intravenous anti-infective therapy within 3 months prior to randomization.
8. Previously or currently diagnosed active tuberculosis Untreated latent tuberculosis.
9. Herpes zoster HIV antibody positive or HCV antibody positive during the screening period.
10. Those who currently have active hepatitis or have severe liver disease and medical history.
11. Patients with malignant tumors.
12. Pregnant and lactating women, and men or women with planned children during the trial period.
13. Those who could not avoid the use of nephrotoxic drugs during the trial.
14. Allergic to human biological products.
15. Patients who have been given any of the clinical trial drugs 4 weeks prior to randomization or within 5 times the half-life of the experimental drug (whichever is longer).
16. Patients deemed ineligible for the trial by the investigator.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept treated group	Drug: Telitacicept; Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete clinical response	a. Proteinuria: protein-to-creatinine ratio <0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.	3-year
The absolute value of eGFR	The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline	3-year
Changes in 24-hour urinary protein	Changes in 24-hour urinary protein at week 104 compared with baseline.	104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR decrease	The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.	3-year
Need for dialysis	progression to end-stage renal disease	3-year

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): September 30, 2026

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: October 25, 2022
• First Posted (Actual): October 27, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 22, 2023
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Nephritis; Glomerulonephritis; Kidney Diseases; Glomerulonephritis, IGA
• Other Study ID Numbers: SZNK

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No