Clinical trial NCT06654596: Efficacy and Safety of Telitacicept in IgAN
Official title: A Multicenter, Randomized, Controlled Clinical Study on the Efficacy and Safety of Telitacicept in Patients with IgA Nephropathy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: IgA Nephropathy (IgAN)
Kidney Diseases
Telitacicept
Glucocorticoid
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
Collaborators: name: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
name: RenJi Hospital
name: Sichuan Provincial People's Hospital
name: Renmin Hospital of Wuhan University
name: Shanghai 6th People's Hospital
name: Shanghai Longhua Hospital
name: Huashan Hospital
name: Shanghai Changzheng Hospital
name: Wannan Medical College Yijishan Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Songjiang Hospital Affiliated to Shanghai Jiaotong University School of Medicine
First posted: 2024-10-23
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change of 24-hour urine protein
timeFrame: From baseline to week 40
Secondary outcomes:
measure: Change of PCR
timeFrame: From baseline to week 40
measure: Annualized eGFR slope
timeFrame: From baseline to week 40
measure: Change of eGFR
timeFrame: From baseline to week 40
measure: Proportion of patients with a decrease in eGFR ≥30%
timeFrame: From baseline to week 40
measure: Proportion of patients with a decrease in eGFR ≥40%
timeFrame: From baseline to week 40
measure: Change of 24-hour urine ACR
timeFrame: From baseline to week 40
measure: Proportion of patients achieving 24-hour urine PCR < 0.6 g/g
timeFrame: From baseline to week 40
measure: Time from the first use of treatment to the occurrence of a composite endpoint event
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital
Study officials:
References: