Efficacy and Safety of Telitacicept in IgAN

NCT06654596 | Recruiting DMC

• 1 other identifier: TETA-IgA
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

IgA Nephropathy (IgAN); Kidney Diseases; Telitacicept; Glucocorticoid

Outcome Measures

Primary Outcomes (1)

• Change of 24-hour urine protein

  Change of 24-hour urine protein from baseline to week 40

  From baseline to week 40

Secondary Outcomes (8)

• Change of PCR

  From baseline to week 40

• Annualized eGFR slope

  From baseline to week 40

• Change of eGFR

  From baseline to week 40

• Proportion of patients with a decrease in eGFR ≥30%

  From baseline to week 40

• Proportion of patients with a decrease in eGFR ≥40%

  From baseline to week 40

Study Arms (2)

Telitacicept+ACEI/ARB

EXPERIMENTAL

Drug: Telitacicept 240mg

Glucocorticoids+ACEI/ARB

ACTIVE COMPARATOR

Drug: Glucocorticoid

Interventions

Telitacicept 240mg DRUG

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.

Telitacicept+ACEI/ARB

Glucocorticoid DRUG

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.

Glucocorticoids+ACEI/ARB

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old, male or female
• Primary IgA nephropathy confirmed by renal biopsy.
• Urine protein ≥ 0.75g/24h or 24-hour urine protein creatinine ratio (PCR) ≥ 0.6 g/g.
• eGFR ≥ 25 ml/min/1.73 m2 calculated using the CKD-EPI formula.
• 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.
• Use of SGLT2, MRA, hydroxychloroquine, and etc. remained unchanged.
• Voluntarily participated in this study and signed the informed consent form.

You may not qualify if:

• Patients with abnormal laboratory indicators (see study protocol for details).
• Secondary IgA nephropathy such as Henoch-Schonlein purpura, SLE, cirrhosis, etc.
• Use of systemic glucocorticoids/immunosuppressants within 3 months (such as cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, tripterygium wilfordii, etc.).
• Use of biological agents within 6 months (rituximab, etc.).
• 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.
• COVID-19 infection within 2 weeks before randomization.
• Live vaccine within 4 weeks before randomization.
• History of malignant tumor within five years.
• Uncontrolled hypertension (systolic blood pressure\>140mmHg or diastolic blood pressure\>90mmHg).
• Poorly controlled diabetes (glycosylated hemoglobin\>8%).
• Pregnant women and breastfeeding women.
• Participating in other clinical trials at the same time.
• Surgery, chemotherapy, radiotherapy and other treatments are planned during the study.

Sponsors & Collaborators

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

Study Sites (1)

Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Glomerulonephritis, IGA; Kidney Diseases

Interventions

telitacicept; Glucocorticoids

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Jingyuan Xie

CONTACT

+86-64370045; nephroxie@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: October 23, 2024
• Study Start: December 6, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 1, 2025

Record last verified: 2024-12

Locations

CN (1)