Back to resultsEfficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
Primary Purpose
Primary IgA Nephropathy
Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR-2010 Injection
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Primary IgA Nephropathy
Eligibility Criteria
Inclusion Criteria: Able and willing to provide a written informed consent Renal biopsy confirmed primary IgA nephropathy 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g eGFR≥30 mL/min/ 1.73m2 40kg≤ Weight ≤100kg Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose). Exclusion Criteria: systemic disease which may cause secondary IgA deposition in the mesangial region Specific type of IgA nephropathy History of severe opportunistic infection A history of chronic or recurrent infection within 1 year prior to screening History of active digestive system within one year Have a malignant tumor or a history of malignant tumor Subjects who have received organ transplants Associated with other serious or poorly controlled systemic diseases Hepatitis, syphilis, human immunodeficiency virus (HIV) infection Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period. Received any systemic glucocorticoid 8 weeks before screening or during run-in period
Sites / Locations
- General Hospital of Eastern Theater CommandRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SHR-2010 Injection
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Part 2: change from baseline in UPCR at 24weeks.
Secondary Outcome Measures
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
Full Information
NCT ID
NCT05847920
First Posted
April 27, 2023
Last Updated
June 12, 2023
Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT05847920
Brief Title
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
Official Title
A Phase II Seamless Design, Randomized, Double-blind, Placebo-controlled, Dose-exploration Study Evaluate the Efficacy and Safety of SHR-2010 Injection in Patients With Primary IgA Nephropathy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 4, 2023 (Actual)
Primary Completion Date
January 30, 2026 (Anticipated)
Study Completion Date
April 30, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary IgA Nephropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SHR-2010 Injection
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SHR-2010 Injection
Intervention Description
SHR-2010 Injection
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Time Frame
12 weeks
Title
Part 2: change from baseline in UPCR at 24weeks.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
Time Frame
12 weeks
Title
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
Time Frame
24 weeks
Title
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
Time Frame
12 weeks
Title
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
Time Frame
24 weeks
Title
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
Time Frame
12, 24 weeks
Title
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
Time Frame
24, 36 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Able and willing to provide a written informed consent
Renal biopsy confirmed primary IgA nephropathy
24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
eGFR≥30 mL/min/ 1.73m2
40kg≤ Weight ≤100kg
Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).
Exclusion Criteria:
systemic disease which may cause secondary IgA deposition in the mesangial region
Specific type of IgA nephropathy
History of severe opportunistic infection
A history of chronic or recurrent infection within 1 year prior to screening
History of active digestive system within one year
Have a malignant tumor or a history of malignant tumor
Subjects who have received organ transplants
Associated with other serious or poorly controlled systemic diseases
Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
Received any systemic glucocorticoid 8 weeks before screening or during run-in period
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fei Gu
Phone
17721288037
Email
fei.gu@hengrui.com
Facility Information:
Facility Name
General Hospital of Eastern Theater Command
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhihong Liu
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy
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