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

March 2, 2025 updated by: Guangdong Hengrui Pharmaceutical Co., Ltd

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

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210002
        • General Hospital of Eastern Theater Command

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Able and willing to provide a written informed consent
  2. Renal biopsy confirmed primary IgA nephropathy
  3. 24 hours urinary protein quantity ≥1g, or UPCR≥0.8 g/g
  4. eGFR≥30 mL/min/ 1.73m2
  5. 40kg≤ Weight ≤100kg
  6. Has been treated with optimized supportive treatment. (ACEI or ARB to maximum recommended dose or maximum tolerated dose).

Exclusion Criteria:

  1. systemic disease which may cause secondary IgA deposition in the mesangial region
  2. Specific type of IgA nephropathy
  3. History of severe opportunistic infection
  4. A history of chronic or recurrent infection within 1 year prior to screening
  5. History of active digestive system within one year
  6. Have a malignant tumor or a history of malignant tumor
  7. Subjects who have received organ transplants
  8. Associated with other serious or poorly controlled systemic diseases
  9. Hepatitis, syphilis, human immunodeficiency virus (HIV) infection
  10. Received systemic immunosuppressive drugs other than glucocorticoids 8 weeks before screening or during run-in period.
  11. Received any systemic glucocorticoid 8 weeks before screening or during run-in period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Placebo
Experimental: SHR-2010 Injection
Drug: SHR-2010 Injection
SHR-2010 Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Part 1: change from baseline in Urine Protein to Creatinine Ratio (UPCR) at 12weeks.
Time Frame: 12 weeks
12 weeks
Part 2: change from baseline in UPCR at 24weeks.
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
change from baseline in 24 hours urinary protein at 12 weeks (part 1)
Time Frame: 12 weeks
12 weeks
change from baseline in 24 hours urinary protein at 24 weeks (part 2)
Time Frame: 24 weeks
24 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 12weeks（Part 1）
Time Frame: 12 weeks
12 weeks
change from baseline in urinary albumin creatinine ratio (UACR) at 24weeks（Part 2）.
Time Frame: 24 weeks
24 weeks
change from baseline in glomerular filtration rate (eGFR) at 12weeks and 24weeks （Part 1）.
Time Frame: 12, 24 weeks
12, 24 weeks
change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.
Time Frame: 24, 36 weeks
24, 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 4, 2023

Primary Completion (Actual)

January 20, 2025

Study Completion (Actual)

January 20, 2025

Study Registration Dates

First Submitted

April 27, 2023

First Submitted That Met QC Criteria

April 27, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR-2010-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe