Efficacy and Safety of Telitacicept in IgAN

A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy

A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.

Study Overview

• Status: Recruiting
• Conditions: Kidney Diseases; IgA Nephropathy (IgAN); Telitacicept; Glucocorticoid
• Intervention / Treatment: Drug: Telitacicept 240mg; Drug: Glucocorticoid

Detailed Description

IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region. Its clinical and pathological manifestations are diverse and heterogeneous. Its pathogenesis has not yet been fully clarified, and there is currently no unified treatment plan. As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, telitacicept has become a new therapeutic target. The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published. It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment. The study showed that telitacicept can effectively reduce patients' proteinuria and reduce the risk of disease progression. Based on the above research results, the investigators plan to conduct a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression.

• Study Type: Interventional
• Enrollment (Estimated): 118
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jingyuan Xie; Phone Number: 665232 +86-64370045; Email: nephroxie@163.com

Study Locations

• China
  • Shanghai, China, 200025
    • Recruiting
    • Ruijin Hospital
    • Contact: Jieming Qu; Phone Number: +86-021-64370045; Email: partyoffice@rjh.com.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18-70 years old, male or female
2. Primary IgA nephropathy confirmed by renal biopsy.
3. Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
4. eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
5. Received treatment with ACEI/ARB for 12 weeks before randomization, and the drug dose (within the maximum tolerated range) was stable within 4 weeks before randomization.
6. Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
7. Voluntarily participated in this study and signed the informed consent form.

Exclusion Criteria:

1. Patients with abnormal laboratory indicators (see study protocol for details).
2. Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
3. Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
4. Use of biological agents within 6 months (rituximab, etc.).
5. Active infection, such as active tuberculosis, active hepatitis, hepatitis C, herpes zoster, HIV, etc. According to the results of the five hepatitis B test: patients with positive HBsAg should be excluded; patients with negative HBsAg but positive HBcAb, regardless of whether HBsAb is positive or negative, need to test HBV-DNA to determine their situation: if HBV-DNA is positive, the patient needs to be excluded; if HBV-DNA is negative, the patient can participate in the trial.
6. COVID-19 infection within 2 weeks before randomization.
7. Live vaccine within 4 weeks before randomization.
8. History of malignant tumor within five years.
9. Uncontrolled hypertension (systolic blood pressure>140mmHg or diastolic blood pressure>90mmHg).
10. Poorly controlled diabetes (glycosylated hemoglobin>8%).
11. Pregnant women and breastfeeding women.
12. Participating in other clinical trials at the same time.
13. Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.
14. Other reasons judged by researchers as unsuitable for inclusion in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept+ACEI/ARB	Drug: Telitacicept 240mg; Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.
Active Comparator: Glucocorticoids+ACEI/ARB	Drug: Glucocorticoid; Patients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of 24-hour urine protein	Change of 24-hour urine protein from baseline to week 40	From baseline to week 40

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of PCR	Change of 24-hour urine protein creatinine ratio (PCR) from baseline to week 40	From baseline to week 40
Annualized eGFR slope	Annualized eGFR slope from baseline to week 40	From baseline to week 40
Change of eGFR	Change of eGFR from baseline to week 40	From baseline to week 40
Proportion of patients with a decrease in eGFR ≥30%	Proportion of patients with a decrease in eGFR ≥30% from baseline to week 40	From baseline to week 40
Proportion of patients with a decrease in eGFR ≥40%	Proportion of patients with a decrease in eGFR ≥40% from baseline to week 40	From baseline to week 40
Change of 24-hour urine ACR	Change of 24-hour urine albumin creatinine ratio (ACR) from baseline to week 40	From baseline to week 40
Proportion of patients achieving 24-hour urine PCR < 0.6 g/g	Proportion of patients achieving 24-hour urine PCR < 0.6 g/g from baseline to week 40	From baseline to week 40
Time from the first use of treatment to the occurrence of a composite endpoint event	Time from the first use of treatment to the occurrence of a composite endpoint event. The composite endpoint event was defined as: the time from the first use of treatment to the first decrease in eGFR from baseline by ≥30% or ≥40% (at least 4 weeks), initiation of maintenance renal dialysis (at least 4 weeks), eGFR <15 mL/min/1.73m2 (at least 4 weeks), renal transplantation, or death due to renal failure.	Up to 40 weeks

Collaborators and Investigators

• Sponsor: Ruijin Hospital
• Collaborators: RenJi Hospital; Huashan Hospital; Xinhua Hospital, Shanghai Jiao Tong University School of Medicine; Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Renmin Hospital of Wuhan University; Shanghai Changzheng Hospital; Sichuan Provincial People's Hospital; Shanghai 6th People's Hospital; Shanghai Longhua Hospital; Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine; Wannan Medical College Yijishan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: October 18, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 30, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Autoimmune Diseases; Immune System Diseases; Glomerulonephritis; Nephritis; Kidney Diseases; Glomerulonephritis, IGA; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucocorticoids
• Other Study ID Numbers: TETA-IgA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No