Telitacicept for IgA Nephropathy

No longer recruiting at 37 trial locations

Overseen By Remegen Biosciences

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: RemeGen Co., Ltd.

Must be taking: AEI/ARB, Diuretics

Disqualifiers: Transplantation, Nephrotic syndrome, Immunocompromised, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 24

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, Telitacicept, can benefit individuals with IgA nephropathy, a kidney disease that can progressively damage the kidneys. The study compares two doses of Telitacicept with a placebo to evaluate its efficacy and safety. Individuals diagnosed with IgA nephropathy through a kidney biopsy and exhibiting a certain level of protein in their urine may qualify for this trial. Participants will receive weekly injections for 24 weeks. As a Phase 2 trial, this research aims to assess the treatment's effectiveness in an initial, smaller group.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have stabilized medications for blood pressure, like AEI/ARB or diuretics, which suggests you may need to continue those.

Is there any evidence suggesting that Telitacicept is likely to be safe for humans?

Research has shown that telitacicept is generally safe for people with IgA nephropathy, a type of kidney disease. In various studies, most patients tolerated telitacicept well. When side effects occur, they are usually mild, such as a headache or a slight reaction at the injection site.

One study found that telitacicept significantly reduced protein in the urine, a marker of kidney disease. This suggests the treatment not only appears safe but may also help reduce disease symptoms.

Overall, the treatment's safety is promising, but discussing potential risks with a healthcare professional is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IgA nephropathy?

Unlike standard treatments for IgA nephropathy, which often include steroids and immunosuppressants, Telitacicept offers a unique approach by targeting the body's immune system more precisely. This drug works by inhibiting the activity of B cells, which play a crucial role in the development of IgA nephropathy. Researchers are excited about Telitacicept because its subcutaneous injection form allows for potentially fewer side effects and more targeted action, compared to the systemic effects of traditional oral medications. With its weekly dosing schedule, Telitacicept could also improve patient compliance, making it a promising alternative for managing this kidney condition.

What evidence suggests that Telitacicept might be an effective treatment for IgA nephropathy?

Research has shown that telitacicept may help treat IgA nephropathy, a kidney disease. One study found that telitacicept significantly lowered protein levels in urine, indicating reduced kidney damage. Lowering these levels can help protect the kidneys from further harm. Another study suggested that using telitacicept for a longer period might more effectively manage this condition. This trial will evaluate different dosages of telitacicept, specifically 160mg and 240mg, to determine its effectiveness. These findings suggest that telitacicept could be a helpful treatment option for people with IgA nephropathy. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

Inclusion Criteria

Your average 24-hour urine protein level is greater than 0.75 grams.

Your kidney function, as measured by estimated GFR, is above a certain level.

You are taking certain medications for high blood pressure.

Exclusion Criteria

You have important abnormal test results from your lab tests.

Your kidney function has decreased rapidly by more than 15 ml/min during the screening process.

People with weakened immune systems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Double-blind Treatment

Participants receive either Telitacicept 160 mg, Telitacicept 240 mg, or placebo subcutaneous injection once weekly for 24 weeks

24 weeks

24 visits (in-person, weekly)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Regular visits as per secondary outcome measures

Open-label Extension (optional)

Participants may opt into continuation of treatment long-term

What Are the Treatments Tested in This Trial?

Interventions

• Telitacicept

How Is the Trial Designed?

Group I: Telitacicept 240mg Experimental Treatment 1 Intervention

Telitacicept 240mg subcutaneous injection once weekly, and a total of 24 doses

Group II: Telitacicept 160mg Experimental Treatment 1 Intervention

Telitacicept 160mg subcutaneous injection once weekly, and a total of 24 doses

Group III: Placebo Placebo Group 1 Intervention

Placebo subcutaneous injection once weekly, and a total of 24 doses

Telitacicept is already approved in China for the following indications:

Approved in China as Tai'ai for:

• Systemic lupus erythematosus (SLE)

Who Is Running the Clinical Trial?

RemeGen Co., Ltd.

Lead Sponsor

Trials

84

Recruited

11,100+

Dr. Jianmin Fang

RemeGen Co., Ltd.

Chief Executive Officer since 2008

PhD in Molecular Biology

Dr. Ruyi He

RemeGen Co., Ltd.

Chief Medical Officer since 2023

MD

Published Research Related to This Trial

Telitacicept is a promising dual-target biological agent that inhibits B cell activating factors (BAFF) and APRIL, which are crucial in the autoimmune pathways associated with IgA nephropathy (IgAN).

By improving renal immune complex function and reducing symptoms like hematuria and proteinuria, telitacicept shows potential for treating IgAN and other autoimmune diseases linked to B cell activity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of telitacicept in the treatment of IgA nephropathy. Wu, L., Du, X., Lu, X.[2023]

Dapagliflozin was found to be significantly more effective than placebo, immunosuppressants, and RAS blockade in preventing end-stage renal disease (ESRD) in IgA nephropathy patients, based on a review of 15 trials involving 1,983 participants.

In terms of safety, dapagliflozin demonstrated a lower risk of serious adverse events compared to glucocorticoids, making it a promising treatment option for patients at high risk of disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness and safety for the treatments despite optimized renin-angiotensin system blockade among IgA nephropathy patients at high-risk of disease progression: A network meta-analysis of randomized controlled trials. Tan, Q., Xue, H., Ni, X., et al.[2023]

Immunosuppressive agents, particularly steroids, significantly lower the risk of progression to end-stage kidney disease (ESRD) in patients with IgA nephropathy, based on a systematic review of 13 trials involving 623 patients.

Alkylating agents were also effective in reducing proteinuria, a key indicator of kidney damage, suggesting that immunosuppressive treatments may be beneficial, although more high-quality studies are needed to determine optimal management strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppressive treatments for immunoglobulin A nephropathy: a meta-analysis of randomized controlled trials. Samuels, JA., Strippoli, GF., Craig, JC., et al.[2022]

Telitacicept is a novel treatment that targets BAFF and APRIL, two proteins crucial for B cell maintenance and function, and has been approved in China for treating systemic lupus erythematosus.

The drug is currently undergoing clinical trials for other autoimmune diseases, highlighting its potential efficacy in managing conditions linked to B cell overactivity, such as lupus nephritis and IgA nephropathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telitacicept for autoimmune nephropathy. Cai, J., Gao, D., Liu, D., et al.[2023]

In a randomized trial involving 86 patients with IgA nephropathy, a 6-month course of steroid treatment significantly reduced the risk of renal function deterioration compared to supportive therapy alone, with only 9 patients in the steroid group experiencing a 50% increase in plasma creatinine versus 14 in the control group.

The steroid treatment was well-tolerated, with no significant side effects reported, indicating that it is a safe option for protecting renal function in patients with this progressive kidney disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Corticosteroids in IgA nephropathy: a randomised controlled trial. Pozzi, C., Bolasco, PG., Fogazzi, GB., et al.[2022]

Atacicept, a B-cell-targeted immunomodulator, demonstrated an acceptable safety profile in a phase II study involving 16 patients with IgA nephropathy, with most treatment-emergent adverse events being mild or moderate.

The treatment led to significant reductions in pathogenic Gd-IgA1 levels and early improvements in proteinuria, while renal function remained stable compared to a decline observed in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Phase II JANUS Study of Atacicept in Patients With IgA Nephropathy and Persistent Proteinuria. Barratt, J., Tumlin, J., Suzuki, Y., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482107/

Effectiveness and safety of telitacicept in IgA nephropathy This study aims to retrospectively assess the clinical outcomes associated with telitacicept in IgAN patients. Methods. Study design and ...

2. academic.oup.com academic.oup.com/ckj/article/18/6/sfaf154/8137896

Efficacy and safety of telitacicept in IgA nephropathy This real-world observational study suggests that extended telitacicept treatment could be a more effective strategy for IgAN patients, ...

3. ir.vorbio.com ir.vorbio.com/news-releases/news-release-details/telitacicept-achieved-primary-endpoint-phase-3-clinical-study-0

Telitacicept Achieved Primary Endpoint in Phase 3 Clinical ... Telitacicept Achieved Primary Endpoint in Phase 3 Clinical Study for IgA Nephropathy. August 27, 2025. PDF Version. Results reinforce ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT04905212

NCT04905212 | A Study of Telitacicept for Injection (RC18) ... This study will seek to determine the safety and efficacy of Telitacicept for Injection (RC18) in the treatment of IgA nephropathy.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2468024922019106

Randomized Phase 2 Trial of Telitacicept in Patients With ... Telitacicept treatment led to a clinically meaningful reduction in proteinuria in patients with IgAN in the present phase 2 clinical trial.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/41089835/?utm_source=FeedFetcher&utm_medium=rss&utm_campaign=pubmed-2&utm_content=1jmC0p0kwOiMcoGeXOqqC5zEb6D0GlbytEo6kTppLvi6MPUM2d&fc=20220207205947&ff=20251027035300&v=2.18.0.post22+67771e2

Efficacy and safety of telitacicept in the treatment of IgA ... Telitacicept monotherapy is safe and effective, and combination with corticosteroids and immunosuppressants may improve the remission rate ...