CClinicalTrials.gg
Sign In
TerminatedNCT05847920Updated Mar 5, 2025

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

A Phase 2 interventional study of SHR-2010 Injection and Placebo in Primary IgA Nephropathy, sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd. Terminated at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-03-05.

Sponsored by Guangdong Hengrui Pharmaceutical Co., Ltd · Phase 2, Interventional, and Treatment

Why this study was terminated
Based on the adjustment of the R \& D strategy, the sponsor decides to terminate the research.
Phase
Phase 2
Study type
Interventional
Enrollment
53
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Primary IgA Nephropathy
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 53 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd is the lead sponsor of 58 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
53 participants (actual)

Study arms

  • Experimental
    SHR-2010 Injection

    Drug: SHR-2010 Injection

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugSHR-2010 Injection

    SHR-2010 Injection

  • DrugPlacebo

    Placebo

06

What researchers measure

Primary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 24 weeks

Secondary outcomes

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

    Time frame: 12 weeks

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

    Time frame: 24 weeks

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

    Time frame: 12 weeks

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

    Time frame: 24 weeks

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

    Time frame: 12, 24 weeks

  6. change from baseline in glomerular filtration rate (eGFR) at 24weeks and 36weeks （Part 2）.

    Time frame: 24, 36 weeks

07

Study locations

1 site
  • General Hospital of Eastern Theater Command
    Nanjing, Jiangsu 210002, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05847920
Lead sponsor
Guangdong Hengrui Pharmaceutical Co., Ltd
Responsible party
Sponsor
First posted
May 8, 2023
Start date
Jun 4, 2023
Primary completion
Jan 20, 2025
Completion
Jan 20, 2025
Last update
Mar 5, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Feb 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Kidney Diseases→

Other studies from this sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Start the discussion