Efficacy and Safety of SHR-2010 Injection in the Treatment of Primary IgA Nephropathy

NCT05847920 | Terminated Phase 2

• 1 other identifier: SHR-2010-201
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

The study is being conducted to evaluate the efficacy, and safety of SHR - 2010 injection in patients with primary IgA nephropathy.

Conditions

Primary IgA Nephropathy

Outcome Measures

Primary Outcomes (2)

• Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.

  12 weeks

• Part 2: change from baseline in UPCR at 24weeks.

  24 weeks

Secondary Outcomes (6)

• change from baseline in 24 hours urinary protein at 12 weeks (part 1)

  12 weeks

• change from baseline in 24 hours urinary protein at 24 weeks (part 2)

  24 weeks

• change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）

  12 weeks

• change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.

  24 weeks

• change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.

  12, 24 weeks

Study Arms (2)

SHR-2010 Injection

EXPERIMENTAL

Drug: SHR-2010 Injection

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

SHR-2010 Injection DRUG

SHR-2010 Injection

SHR-2010 Injection

Placebo DRUG

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Able and willing to provide a written informed consent
• Renal biopsy confirmed primary IgA nephropathy
• hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
• eGFR≥30 mL/min/ 1.73m2
• kg≤ Weight ≤100kg
• Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

You may not qualify if:

• 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

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

• Tunnicliffe DJ, Reid S, Craig JC, Samuels JA, Molony DA, Strippoli GF. Non-immunosuppressive treatment for IgA nephropathy. Cochrane Database Syst Rev. 2024 Feb 1;2(2):CD003962. doi: 10.1002/14651858.CD003962.pub3.

  PMID: 38299639 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, IGA

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 8, 2023
• Study Start: June 4, 2023
• Primary Completion: January 20, 2025
• Study Completion: January 20, 2025
• Last Updated: March 5, 2025

Record last verified: 2025-02

Locations

CN (1)