A Study of Telitacicept in Patients With Primary IgA Nephropathy

IgA Nephropathy Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of Telitacicept in Patients With IgA Nephropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05799287
• Other study ID #: 18C021
• Status: Recruiting
• Phase: Phase 3
• Start date: April 28, 2023
• Est. completion date: December 2025

Study information

• Verified date: September 2023
• Source: RemeGen Co., Ltd.
• Contact: Binghua Xiao
• Phone: 86-101-58076833
• Email: binghua.xiao[@]remegen.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy.

Description:

This study consists of a 5-week screening period, a double-blind treatment period divided into phase A and phase B. Eligible subjects will be randomly assigned in a 1:1 ratio to receive either Telitacicept 240mg or placebo. Subjects will be given SC Telitacicept or placebo once a week for a total of 39 doses in phase A and once every 2 weeks for a total of 32 doses in phase B.

Primary endpoint of phase A will be measured at week 39. Primary endpoint of phase B will be measured at week 104.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 308
• Est. completion date: December 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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 = 0.5 g/g 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 clinically significant abnormal laboratory tests;

2. Patients with secondary IgA nephropathy;

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 office SBP>140 mmHg or DBP>90 mmHg during the screening period;

8. HbA1c>8% (64mmol/mol);

9. Treatment with immunosuppressants (cyclophosphamide, azathioprine, mycophenolate, leflunomide, tacrolimus, cyclosporine, Tripterygium wilfordii, etc.) within 12 weeks prior to randomization;

10. Treatment with anti-CD20 therapy within 24 weeks prior to randomization;

11. Treatment with systemic glucocorticoid within 12 weeks prior to randomization;

12. Hospitalization or intravenous anti-infective therapy for active infection within 4 weeks prior to randomization;

13. Patients with active tuberculosis and untreated latent tuberculosis;

14. Hepatitis B: patients with active hepatitis (patients with positive HBsAg) or latent hepatitis B (patients with positive HBcAb and positive HBV-DNA);

15. Patients with hepatitis C;

16. Patients with HIV;

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. Unavoidable use of drugs with renal toxicity during the study;

20. Allergic to biological products of human origin;

21. Patients who have received any investigational therapy within 4 weeks or within 5 times the half-life of the investigational product (whichever is longer) prior to randomization;

22. Live vaccination within 4 weeks prior to randomization;

23. Patients with COVID-19 infection within 4 weeks of randomization or patients with a history of serious COVID-19 disease requiring hospitalization within 52 weeks prior to screening;

24. Drug or alcohol abuse/dependence within 52 weeks prior to randomization;

25. Not suitable for the study in the opinion of the investigator.

Related Conditions & MeSH terms

• Glomerulonephritis, IGA
• IgA Nephropathy
• Kidney Diseases

Intervention

Biological:
• Telitacicept
Telitacicept 240 mg SC

Drug:
• Placebo
Placebo to Telitacicept

Locations

Country	Name	City	State
China	Affiliated Hospital of Hebei University	Baoding	Hebei
China	The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology	Baotou	Inner Mongolia Autonomous Region
China	Beijing Anzhen Hospital Affiliated to Capital Medical University	Beijing	Beijing
China	Beijing Hospital	Beijing	Beijing
China	Beijing Tsinghua Changgeng Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Peking University People's Hospital	Beijing	Beijing
China	Peking University Shougang Hospital	Beijing	Beijing
China	The First Affiliated Hospital of Bengbu Medical College	Bengbu	Anhui
China	Cangzhou Central Hospital	Cangzhou	Hebei
China	China-Japan Union Hospital of Jilin University	Changchun	Jilin
China	Jilin Province People's Hospital	Changchun	Jilin
China	The First Hospital of Jilin University	Changchun	Jilin
China	The Second Hospital of Jilin University	Changchun	Jilin
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan
China	The Third Xiangya Hospital of Central South University	Changsha	Hunan
China	Xiangya Hospital of Central South University	Changsha	Hunan
China	Changzhou No.2 People's Hospital	Changzhou	Jiangsu
China	Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital	Chengdu	Sichuan
China	West China Hospital of Sichuan University	Chengdu	Sichuan
China	The First Affiliated Hospital of Army Medical University	Chongqing	Chongqing
China	The Second Affiliated Hospital of Chongqing Medical University	Chongqing	Chongqing
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	The Second Affiliated Hospital of Guangzhou Medical University	Guangzhou	Guangdong
China	The Third Affiliated Hospital of Southern Medical University	Guangzhou	Guangdong
China	Zhujiang Hospital of Southern Medical University	Guangzhou	Guangdong
China	Affiliated Hospital of Guilin Medical College	Guilin	Guangxi Zhuang Autonomous Region
China	Guizhou Provincial People's Hospital	Guiyang	Guizhou
China	Handan First Hospital	Handan	Hebei
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Tongde Hospital of Zhejing Province	Hangzhou	Zhejing
China	Zhejiang Provincial People's Hospital	Hangzhou	Zhejiang
China	The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)	Hefei	Anhui
China	The Second Affiliated Hospital of Anhui Medical University	Hefei	Anhui
China	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia Autonomous Region
China	Qilu Hospital of Shandong University	Jinan	Shandong
China	Shandong Provincial Hospital	Jinan	Shandong
China	Shandong Provincial Qianfoshan Hospital	Jinan	Shandong
China	Jinhua Municipal Central Hospital	Jinhua	Zhejiang
China	The First People's Hospital of Yunnan Province	Kunming	Yunnan
China	Gansu Provincial Hospital	Lanzhou	Gansu
China	Lanzhou University Second Hospital	Lanzhou	Gansu
China	The First Hospital of Lanzhou University	Lanzhou	Gansu
China	Linyi People's Hospital	Linyi	Shandong
China	Liuzhou Workers Hospital	Liuzhou	Guangxi Zhuang Autonomous Region
China	The First Affiliated Hospital of Henan University of science and Technology	Luoyang	Henan
China	Jiangxi Provincial People's Hospital	Nanchang	Jiangxi
China	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	The Second Affiliated Hospital of Nanchang University	Nanchang	Jiangxi
China	Jiangsu Provincial People's Hospital	Nanjing	Jiangsu
China	Zhongda Hospital Southeast University	Nanjing	Jiangsu
China	The First Affiliated Hospital of Guangxi Medical University	Nanning	Guangxi Zhuang Autonomous Region
China	Nanyang Central Hospital	Nanyang	Henan
China	Ningbo First Hospital	Ningbo	Zhejiang
China	Ningbo No.2 Hospital	Ningbo	Zhejiang
China	Ningbo Traditional Chinese Medicine Hospital	Ningbo	Zhejiang
China	The Affiliated Hospital of Qingdao University	Qingdao	Shandong
China	First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Huashan Hospital Affiliated to Fudan University	Shanghai	Shanghai
China	Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine	Shanghai	Shanghai
China	Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine	Shanghai	Shanghai
China	Shantou Central Hospital	Shantou	Guangdong
China	General Hospital of Northern Theatre Command of Chinese People's Liberation Army	Shenyang	Liaoning
China	Shengjing Hospital of China Medical University	Shenyang	Liaoning
China	The Affiliated Central Hospital of Shenyang Medical College	Shenyang	Liaoning
China	Longgang District People's Hospital of Shenzhen	Shenzhen	Guangdong
China	Peking University Shenzhen Hospital	Shenzhen	Guangdong
China	Shenzhen Hospital of Southern Medical University	Shenzhen	Guangdong
China	Shenzhen People's Hospital	Shenzhen	Guangdong
China	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei
China	First Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Second Hospital of Shanxi Medical University	Taiyuan	Shanxi
China	Shanxi Bethune Hospital	Taiyuan	Shanxi
China	Shanxi Provincial People's Hospital	Taiyuan	Shanxi
China	Taizhou Hospital of Zhejiang Province	Taizhou	Zhejiang
China	The Second Hospital of Tianjin Medical University	Tianjin	Tianjin
China	Tianjin Medical University General Hospital	Tianjin	Tianjin
China	People's Hospital of Xinjiang Uygur Autonomous Region	Urumqi	Xinjiang Uygur Autonomous Region
China	The First Affiliated Hospital of Xinjiang Medical University	Urumqi	Xinjiang Uygur Autonomous Region
China	The First Affiliated Hospital of Wenzhou Medical University	Wenzhou	Zhejiang
China	Wenzhou Central Hospital	Wenzhou	Zhejiang
China	Wenzhou People's Hospital	Wenzhou	Zhejiang
China	Renmin Hospital of Wuhan University	Wuhan	Hubei
China	Zhongnan Hospital of Wuhan University	Wuhan	Hubei
China	Yijishan Hospital of Wannan Medical College	Wuhu	Anhui
China	Wuxi People's Hospital	Wuxi	Jiangsu
China	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The Second Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi
China	The First Affiliated Hospital of Xiamen University	Xiamen	Fujian
China	Zhongshan Hospital Affiliated to Xiamen University	Xiamen	Fujian
China	Xingtai People's Hospital	Xingtai	Hebei
China	The Affiliated Hospital of Xuzhou Medical University	Xuzhou	Jiangsu
China	Yantai Yuhuangding Hospital	Yantai	Shandong
China	The Second People's Hospital of Yibin	Yibin	Sichuan
China	General Hospital of Ningxia Medical University	Yinchuan	Ningxia Hui Autonomous Region
China	The First Affiliated Hospital of Hebei North University	Zhangjiakou	Hebei
China	Affiliated Hospital of Guangdong Medical University	Zhanjiang	Guangdong
China	Henan Provincial People's Hospital	Zhengzhou	Henan
China	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan
China	Zhuhai People's Hospital	Zhuhai	Guangdong
China	Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou

Sponsors (1)

Lead Sponsor	Collaborator
RemeGen Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from baseline in 24-hour urine protein at Week 39	Change from baseline in 24-hour urine protein at Week 39	Week 39
Primary	Change from baseline in urine protein creatinine ratio (UPCR) (based on a 24-hour urine sample) at Week 39	Primary endpoint of phase A	Week 39
Primary	Annualized estimated glomerular filtration rate (eGFR) slope at Week 104	Primary endpoint of phase B	Week 104
Secondary	Change from baseline in urine protein creatinine ratio (UPCR) (based on a 24-hour urine sample) at weeks 52, 78, and 104	Change from baseline in UPCR at weeks 52, 78, and 104	weeks 52, 78, and 104
Secondary	Change from baseline in estimated glomerular filtration rate (eGFR) at weeks 39, 52, 78 and 104	Change from baseline in eGFR at weeks 39, 52, 78 and 104	weeks 39, 52, 78 and 104
Secondary	Change from baseline in urine albumin-to-creatinine ratio (UACR) (based on a 24-hour urine sample) at weeks 39, 52, 78 and 104	Change from baseline in UACR (based on a 24-hour urine sample) at weeks 39, 52, 78 and 104	weeks 39, 52, 78 and 104
Secondary	Proportion of subjects achieving urine protein creatinine ratio (UPCR) < 0.8 g/g (based on a 24-hour urine sample) at weeks 39, 52, 78 and 104	Proportion of subjects achieving UPCR < 0.8 g/g (based on a 24-hour urine sample) at weeks 39, 52, 78 and 104	weeks 39, 52, 78 and 104
Secondary	Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) from baseline at Week 39	Proportion of patients with a 30% decrease in eGFR from baseline at Week 39	Week 39
Secondary	Annualized estimated glomerular filtration rate (eGFR) slope at Week 52	Annualized eGFR slope at Week 52	Week 52
Secondary	Time to first occurrence of 30% decrease in estimated glomerular filtration rate (eGFR)	Time to first occurrence of 30% decrease in eGFR since the first dose of the study medicine	up to 104 weeks
Secondary	Proportion of subjects who received rescue therapy at weeks 52, 78, and 104	Proportion of subjects who received rescue therapy at weeks 52, 78, and 104	weeks 52, 78, and 104
Secondary	Time to composite endpoint event	The composite endpoint event is defined as initiation of maintenance renal dialysis (for at least 1 month), renal transplant, renal failure (eGFR < 15 mL/min/1.73 m2 or greater than 30% decrease in eGFR from baseline), or death due to renal failure.	up to 104 weeks
Secondary	Incidence and severity of adverse events	An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.	up to 104 weeks