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A Study of Telitacicept in Patients With Primary IgA Nephropathy

Sponsor
RemeGen Co., Ltd. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05799287
Collaborator
(none)
308
Enrollment
80
Locations
2
Arms
32
Anticipated Duration (Months)
3.9
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Telitacicept
  • Drug: Placebo
 Phase 3

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
308 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Anticipated Study Start Date :
Apr 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Telitacicept

Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.

Biological: Telitacicept
Telitacicept 240 mg SC
Other Names:
  • RC18

    		•
    Placebo Comparator: Placebo

    Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.

    Drug: Placebo
    Placebo to Telitacicept

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in urine protein creatinine ratio (UPCR) (based on a 24-hour urine sample) at Week 39 [Week 39]

      Primary endpoint of phase A

    2. Annualized estimated glomerular filtration rate (eGFR) slope at Week 104 [Week 104]

      Primary endpoint of phase B

    Secondary Outcome Measures

    1. Change from baseline in urine protein creatinine ratio (UPCR) (based on a 24-hour urine sample) at weeks 52, 78, and 104 [weeks 52, 78, and 104]

      Change from baseline in UPCR at weeks 52, 78, and 104

    2. Change from baseline in estimated glomerular filtration rate (eGFR) at weeks 39, 52, 78 and 104 [weeks 39, 52, 78 and 104]

      Change from baseline in eGFR at weeks 39, 52, 78 and 104

    3. Change from baseline in urine albumin-to-creatinine ratio (UACR) (based on a 24-hour urine sample) at weeks 39, 52, 78 and 104 [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

    4. 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 [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

    5. Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) from baseline at Week 39 [Week 39]

      Proportion of patients with a 30% decrease in eGFR from baseline at Week 39

    6. Annualized estimated glomerular filtration rate (eGFR) slope at Week 52 [Week 52]

      Annualized eGFR slope at Week 52

    7. Time to first occurrence of 30% decrease in estimated glomerular filtration rate (eGFR) [up to 104 weeks]

      Time to first occurrence of 30% decrease in eGFR since the first dose of the study medicine

    8. Proportion of subjects who received rescue therapy at weeks 52, 78, and 104 [weeks 52, 78, and 104]

      Proportion of subjects who received rescue therapy at weeks 52, 78, and 104

    9. Time to composite endpoint event [up to 104 weeks]

      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.

    10. Incidence and severity of adverse events [up to 104 weeks]

      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.

    Other Outcome Measures

    1. Change from baseline in 24-hour urine protein at Week 39 [Week 39]

      Change from baseline in 24-hour urine protein at Week 39

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital) Hefei Anhui China
    2 The Second Affiliated Hospital of Anhui Medical University Hefei Anhui China
    3 Yijishan Hospital of Wannan Medical College Wuhu Anhui China
    4 Beijing Anzhen Hospital Affiliated to Capital Medical University Beijing Beijing China
    5 Beijing Hospital Beijing Beijing China
    6 Beijing Tsinghua Changgeng Hospital Beijing Beijing China
    7 Peking University First Hospital Beijing Beijing China
    8 Peking University People's Hospital Beijing Beijing China
    9 Peking University Shougang Hospital Beijing Beijing China
    10 The First Affiliated Hospital of Army Medical University Chongqing Chongqing China
    11 The First Affiliated Hospital of Xiamen University Xiamen Fujian China
    12 Zhongshan Hospital Affiliated to Xiamen University Xiamen Fujian China
    13 The First Hospital of Lanzhou University Lanzhou Gansu China
    14 Guangdong Provincial People's Hospital Guangzhou Guangdong China
    15 The Second Affiliated Hospital of Guangzhou Medical University Guangzhou Guangdong China
    16 The Third Affiliated Hospital of Southern Medical University Guangzhou Guangdong China
    17 Zhujiang Hospital of Southern Medical University Guangzhou Guangdong China
    18 Peking University Shenzhen Hospital Shenzhen Guangdong China
    19 Shenzhen Hospital of Southern Medical University Shenzhen Guangdong China
    20 Shenzhen People's Hospital Shenzhen Guangdong China
    21 Zhuhai People's Hospital Zhuhai Guangdong China
    22 Affiliated Hospital of Guilin Medical College Guilin Guangxi Zhuang Autonomous Region China
    23 Liuzhou Workers Hospital Liuzhou Guangxi Zhuang Autonomous Region China
    24 Guizhou Provincial People's Hospital Guiyang Guizhou China
    25 Affiliated Hospital of Hebei University Baoding Hebei China
    26 Cangzhou Central Hospital Cangzhou Hebei China
    27 First Hospital of Qinhuangdao Qinhuangdao Hebei China
    28 The Second Hospital of Hebei Medical University Shijiazhuang Hebei China
    29 Xingtai People's Hospital Xingtai Hebei China
    30 Henan Provincial People's Hospital Zhengzhou Henan China
    31 The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan China
    32 Renmin Hospital of Wuhan University Wuhan Hubei China
    33 Zhongnan Hospital of Wuhan University Wuhan Hubei China
    34 The Second Xiangya Hospital of Central South University Changsha Hunan China
    35 The Third Xiangya Hospital of Central South University Changsha Hunan China
    36 Xiangya Hospital of Central South University Changsha Hunan China
    37 The First Affiliated Hospital of Baotou Medical College, Inner Mongolia University of Science and Technology Baotou Inner Mongolia Autonomous Region China
    38 The Affiliated Hospital of Inner Mongolia Medical University Hohhot Inner Mongolia Autonomous Region China
    39 Changzhou No.2 People's Hospital Changzhou Jiangsu China
    40 Jiangsu Provincial People's Hospital Nanjing Jiangsu China
    41 Zhongda Hospital Southeast University Nanjing Jiangsu China
    42 Wuxi People's Hospital Wuxi Jiangsu China
    43 Jiangxi Provincial People's Hospital Nanchang Jiangxi China
    44 The Second Affiliated Hospital of Nanchang University Nanchang Jiangxi China
    45 China-Japan Union Hospital of Jilin University Changchun Jilin China
    46 Jilin Province People's Hospital Changchun Jilin China
    47 The First Hospital of Jilin University Changchun Jilin China
    48 The Second Hospital of Jilin University Changchun Jilin China
    49 General Hospital of Northern Theatre Command of Chinese People's Liberation Army Shenyang Liaoning China
    50 Shengjing Hospital of China Medical University Shenyang Liaoning China
    51 The Affiliated Central Hospital of Shenyang Medical College Shenyang Liaoning China
    52 General Hospital of Ningxia Medical University Yinchuan Ningxia Hui Autonomous Region China
    53 The First Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China
    54 The Second Affiliated Hospital of Xi'an Jiaotong University Xi'an Shaanxi China
    55 Qilu Hospital of Shandong University Jinan Shandong China
    56 Shandong Provincial Hospital Jinan Shandong China
    57 Shandong Provincial Qianfoshan Hospital Jinan Shandong China
    58 Linyi People's Hospital Linyi Shandong China
    59 The Affiliated Hospital of Qingdao University Qingdao Shandong China
    60 Yantai Yuhuangding Hospital Yantai Shandong China
    61 Huashan Hospital Affiliated to Fudan University Shanghai Shanghai China
    62 Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine Shanghai Shanghai China
    63 Second Hospital of Shanxi Medical University Taiyuan Shanxi China
    64 Shanxi Bethune Hospital Taiyuan Shanxi China
    65 Shanxi Provincial People's Hospital Taiyuan Shanxi China
    66 Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital Chengdu Sichuan China
    67 West China Hospital of Sichuan University Chengdu Sichuan China
    68 The Second People's Hospital of Yibin Yibin Sichuan China
    69 The Second Hospital of Tianjin Medical University Tianjin Tianjin China
    70 Tianjin Medical University General Hospital Tianjin Tianjin China
    71 People's Hospital of Xinjiang Uygur Autonomous Region Urumqi Xinjiang Uygur Autonomous Region China
    72 The First Affiliated Hospital of Xinjiang Medical University Urumqi Xinjiang Uygur Autonomous Region China
    73 The First People's Hospital of Yunnan Province Kunming Yunnan China
    74 The First Affiliated Hospital, Zhejiang University School of Medicine Hangzhou Zhejiang China
    75 Zhejiang Provincial People's Hospital Hangzhou Zhejiang China
    76 Jinhua Municipal Central Hospital Jinhua Zhejiang China
    77 Ningbo First Hospital Ningbo Zhejiang China
    78 Ningbo Huamei Hospital, University of Chinese Academy of Sciences Ningbo Zhejiang China
    79 The First Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang China
    80 Wenzhou People's Hospital Wenzhou Zhejiang China

    Sponsors and Collaborators

    • RemeGen Co., Ltd.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    RemeGen Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT05799287
    Other Study ID Numbers:
    • 18C021
    First Posted:
    Apr 5, 2023
    Last Update Posted:
    Apr 5, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by RemeGen Co., Ltd.
    Kidney Diseases
    Autoimmune Diseases
    Immune System Diseases
    Additional relevant MeSH terms:
    Kidney Diseases
    Glomerulonephritis, IGA

    Study Results

    No Results Posted as of Apr 5, 2023