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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-04

Study Completion Date

2025-01-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Trial of HRS-5965 Tablets in Primary IgA Nephropathy

NCT06137768

Primary IgA Nephropathy

ACTIVE_NOT_RECRUITING PHASE2

A Trial of HRS-5965 Capsule in Primary IgA Nephropathy

NCT07014826

Primary IgA Nephropathy

RECRUITING PHASE3

Phase II Randomized, Open-label, Multicenter Clinical Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of SHR-2173 Injection in Patients With Primary Membranous Nephropathy

NCT07289763

Primary Membranous Nephropathy

RECRUITING PHASE2

Evaluate the Efficacy and Safety of SHR1459 Tablets in Patients With Primary Membranous Nephropathy

NCT05136456

Primary Membranous Nephropathy

UNKNOWN PHASE2

Safety and Tolerance of Increased Doses of SHR-2106 Injection in Healthy Subjects

NCT05948059

Kidney Transplantation

ENROLLING_BY_INVITATION PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Primary IgA Nephropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SHR-2010 Injection

Group Type EXPERIMENTAL

SHR-2010 Injection

Intervention Type DRUG

SHR-2010 Injection

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SHR-2010 Injection

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No