Active, not recruiting
Phase 3
A Study of Telitacicept for IgA Nephropathy (TELIGAN)
Condition(s) studied
Primary IgA Nephropathy
Investigational drug(s) / intervention(s)
Telitacicept: Subcutaneous injection
Placebo: Placebo to Telitacicept
Study summary
The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).
Eligibility
Inclusion Criteria:
1. Voluntary informed consent provided;
2. Male or female aged ≥ 18 years old;
3. IgA nephropathy confirmed by pathological biopsy;
4. During the screening period, UPCR ≥ 0.8 g/g or 24-hour urine protein ≥ 1.0 g/day based on 24-hour urine collection at Visit 1 and/or Visit 2 and at Visit 3;
5. eGFR ≥ 30 mL/min per 1.73 m\^2 (using the CKD-EPI);
6. Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.
Exclusion Criteria:
1. Subjects with abnormal laboratory tests, including but not limited to the following:
1. White blood cell count \< 1.5×109/L
2. Neutrophils \< 1.0×109/L
3. Hemoglobin \< 85.0 g/L
4. Platelet count \< 80.0×109/L
5. Total bilirubin \>2×ULN
6. ALT\>3×ULN
7. AST\>3×ULN
8. Alkaline phosphatase\>2×ULN
9. Creatine kinase\>5×ULN
10. IgA\<10 mg/dL; or IgG≤400mg/dL;
2. Patients with secondary IgA nephropathy, including but not limited to: Henoch-Schonlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.;
3. Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;;
4. Renal transplant;
5. Patients with cirrhosis, as assessed by the investigator;
6. Patients who experienced any of the following cardiovascular and cerebrovascular events within 24 weeks prior to randomization: myocardial infarction, unstable angina, ventricular arrhythmia, NYHA Class II or higher heart failure, stroke, etc.;
7. Sitting position SBP\>140 mmHg or DBP\>90 mmHg for at least once at 2 visits during the screening period;
8. Patients with poorly controlled type 1 and type 2 diabetes (glycated hemoglobin A1c\[HbA1c\] \> 8% or 64mmol/mol);
9. Treatment with immunosuppressants within 12 weeks prior to randomization, including but not limited to cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii;
10. Treatment with anti-CD20 therapy (for example, Rituximb Injection) within 24 weeks prior to randomization;
11. Received systemic glucocorticoid treatment within 12 weeks prior to randomization, excluding the followings: ① received systemic treatment with prednisolone ≤ 0.5mg/kg or equivalent glucocorticoid for non- IgA nephropathy for no more than 3 courses (≤ 2 weeks per course) in the past 52 weeks; ② topical administration or nasal inhalation;
12. Had hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;
13. Patients with active tuberculosis;
14. Hepatitis B: patients with active or latent hepatitis B (potive HBcAb and HBV-DNA); According to the test results of hepatitis B five items, subjects with positive HBsAg will be excluded; subjects who are HBsAg-negative but HBcAb-positive, whether HBsAb is positive or negative, should be tested for HBV-DNA: if HBV-DNA is positive, patients should be excluded; if HBV-DNA is negative, patients can participate in the trial, and subjects are advised to take oral entecavir for prophylactic antiviral therapy during the trial;
15. Patients with hepatitis C;
16. Patients with HIV infection;
17. Patients with malignancy within the past 5 years, except for treated cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, colon polyps, or cervical cancer in situ;
18. Pregnant women, lactating women, and subjects with childbearing plans during the trial;
19. Allergic to biological products of human origin;
20. Participated in any clinical trial within 4 weeks or within 5 times the half-life of the investigational drug participating (whichever is longer) prior to randomization;
21. Received live vaccination within 4 weeks prior to randomization;
22. Drug or alcohol abuse/dependence within 52 weeks prior to randomization;
23. Other circumstances that, in the opinion of the investigator, are not suitable for participation in this study.
Primary outcome measure(s)
- Change from baseline in urine protein creatinine ratio (UPCR) — 39 weeks
Based on a 24-hour urine collections.
- Annualized estimated glomerular filtration rate (eGFR) slope — 104 weeks
eGFR is calculated using the CKD-EPI formula.
Trial sites (101)
| Facility | City | Region | Status |
| The First Affiliated Hospital of Bengbu Medical University |
Bengbu |
Anhui |
|
| The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) |
Hefei |
Anhui |
|
| The Second Hospital of Anhui Medical University |
Hefei |
Anhui |
|
| The First Affiliated Hospital of Wannan Medical College |
Wuhu |
Anhui |
|
| Beijing Anzhen Hospital Affiliated to Capital Medical University |
Beijing |
Beijing Municipality |
|
| Beijing Hospital |
Beijing |
Beijing Municipality |
|
| Beijing Tsinghua Changgung Hospital |
Beijing |
Beijing Municipality |
|
| Peking University First Hospital |
Beijing |
Beijing Municipality |
|
| Peking University People's Hospital |
Beijing |
Beijing Municipality |
|
| Peking University Shougang Hospital |
Beijing |
Beijing Municipality |
|
| The First Affiliated Hospital of Army Medical University |
Chongqing |
Chongqing Municipality |
|
| The Second Affiliated Hospital of Chongqing Medical University |
Chongqing |
Chongqing Municipality |
|
| The First Affiliated Hospital of Xiamen University |
Xiamen |
Fujian |
|
| Zhongshan Hospital Xiamen University |
Xiamen |
Fujian |
|
| Gansu Provincial Hospital |
Lanzhou |
Gansu |
|
| Lanzhou University Second Hospital |
Lanzhou |
Gansu |
|
| The First Hospital of Lanzhou University |
Lanzhou |
Gansu |
|
| Guangdong Provincial People's Hospital |
Guangzhou |
Guangdong |
|
| The Second Affiliated Hospital of Guangzhou Medical University |
Guangzhou |
Guangdong |
|
| The Third Affiliated Hospital of Southern Medical University |
Guangzhou |
Guangdong |
|
| Zhujiang Hospital of Southern Medical University |
Guangzhou |
Guangdong |
|
| Shantou Central Hospital |
Shantou |
Guangdong |
|
| Longgang District People's Hospital of Shenzhen |
Shenzhen |
Guangdong |
|
| Peking University Shenzhen Hospital |
Shenzhen |
Guangdong |
|
| Shenzhen Hospital of Southern Medical University |
Shenzhen |
Guangdong |
|
| Shenzhen People's Hospital |
Shenzhen |
Guangdong |
|
| Affiliated Hospital of Guangdong Medical University |
Zhanjiang |
Guangdong |
|
| Zhuhai People's Hospital |
Zhuhai |
Guangdong |
|
| The First Affiliated Hospital of Guilin Medical University |
Guilin |
Guangxi |
|
| Liuzhou Workers' Hospital |
Liuzhou |
Guangxi |
|
| The First Affiliated Hospital of Guangxi Medical University |
Nanning |
Guangxi |
|
| Guizhou Provincial People's Hospital |
Guiyang |
Guizhou |
|
| Affiliated Hospital of Zunyi Medical University |
Zunyi |
Guizhou |
|
| Affiliated Hospital of Hebei University |
Baoding |
Hebei |
|
| Cangzhou Central Hospital |
Cangzhou |
Hebei |
|
| Handan First Hospital |
Handan |
Hebei |
|
| First Hospital of Qinhuangdao |
Qinhuangdao |
Hebei |
|
| The Second Hospital of Hebei Medical University |
Shijiazhuang |
Hebei |
|
| Xingtai People's Hospital |
Xingtai |
Hebei |
|
| The First Affiliated Hospital of Hebei North University |
Zhangjiakou |
Hebei |
|
+ 61 more sites — see the full list on the official registry below.
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