Brief Summary

The purpose of this study is to evaluate the efficacy and safety of Telitacicept in patients with primary IgA nephropathy at risk of progressing to end-stage renal disease(ESRD), despite maximum tolerated treatment with renin-angiotensin system(RAS) blockade using angiotensin converting enzyme inhibitors (ACEIs) or angiotensin II type I receptor blockers (ARBs).

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

318

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Apr 2023

Typical duration for phase_3

Geographic Reach

1 country

101 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

3.1 years study duration

First Submitted

Initial submission to the registry

March 5, 2023

Completed

1 month until next milestone

First Posted

Study publicly available on registry

April 5, 2023

Completed

23 days until next milestone

Study Start

First participant enrolled

April 28, 2023

Completed

3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed

Last Updated

December 16, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

March 5, 2023

Last Update Submit

December 8, 2025

Conditions

Primary IgA Nephropathy

Keywords

Autoimmune DiseasesImmune System DiseasesIgA Nephropathy

Outcome Measures

Primary Outcomes (2)

Change from baseline in urine protein creatinine ratio (UPCR)
Based on a 24-hour urine collections.
39 weeks
Annualized estimated glomerular filtration rate (eGFR) slope
eGFR is calculated using the CKD-EPI formula.
104 weeks

Secondary Outcomes (11)

Proportion of patients with a 30% decrease in estimated glomerular filtration rate (eGFR) compared with baseline
39 weeks
Time to 30% reduction from baseline in eGFR
up to 104 weeks
Proportion of patients with a 40% decrease in estimated glomerular filtration rate (eGFR) compared with baseline
up to 104 weeks
Proportion of patients received rescue treatment.
up to 104 weeks
Incidence and severity of adverse events
up to 104 weeks
+6 more secondary outcomes

Other Outcomes (1)

Change from baseline in 24-hour urine protein
39 weeks

Study Arms (2)

Telitacicept

EXPERIMENTAL

Subjects will be given Telitacicept 240 mg SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.

Biological: Telitacicept

Placebo

PLACEBO COMPARATOR

Subjects will be given placebo SC once a week in phase A for a total of 39 doses and once every 2 weeks in phase B for a total of 32 doses.

Drug: Placebo

Interventions

TelitaciceptBIOLOGICAL

Subcutaneous injection

Also known as: RC18

Telitacicept

PlaceboDRUG

Placebo to Telitacicept

Placebo

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Voluntary informed consent provided;
Male or female aged ≥ 18 years old;
IgA nephropathy confirmed by pathological biopsy;
During the screening period, UPCR ≥ 0.8 g/g or 24-hour urine protein ≥ 1.0 g/day based on 24-hour urine collection at Visit 1 and/or Visit 2 and at Visit 3;
eGFR ≥ 30 mL/min per 1.73 m\^2 (using the CKD-EPI);
Have been on a treatment regimen including ACEI/ARB for 12 weeks and on a stable use of ACEI/ARB medication at the maximum tolerated dose/maximum allowable dose within 4 weeks prior to randomization. Subjects who use both ACEIs and ARBs will be excluded.

You may not qualify if:

Subjects with abnormal laboratory tests, including but not limited to the following:
White blood cell count \< 1.5×109/L
Neutrophils \< 1.0×109/L
Hemoglobin \< 85.0 g/L
Platelet count \< 80.0×109/L
Total bilirubin \>2×ULN
ALT\>3×ULN
AST\>3×ULN
Alkaline phosphatase\>2×ULN
Creatine kinase\>5×ULN
IgA\<10 mg/dL; or IgG≤400mg/dL；
Patients with secondary IgA nephropathy, including but not limited to: Henoch-Schonlein purpura, ankylosing spondylitis, systemic lupus erythematosus, etc.;
Patients with other types of glomerular disease such as crescentic glomerulonephritis, minimal change nephropathy with IgA deposition;;
Renal transplant;
Patients with cirrhosis, as assessed by the investigator;
+18 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

RemeGen Co., Ltd.lead

Study Sites (101)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

Location

The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)

Hefei, Anhui, China

Location

The Second Hospital of Anhui Medical University

Hefei, Anhui, China

Location

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Beijing Anzhen Hospital Affiliated to Capital Medical University