Telitacicept for IgA Nephropathy

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

15 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Telitacicept for IgA Nephropathy?

Telitacicept is shown to be effective in treating IgA Nephropathy by targeting and inhibiting specific proteins (BLyS and APRIL) that are important in the disease's autoimmune processes, helping to improve kidney function and reduce symptoms like blood and protein in the urine. ^{1 2 3 4 5}

Is Telitacicept safe for humans?

The available research does not provide specific safety data for Telitacicept (also known as RC-18, RCT-18, or Tai'ai) in humans, particularly for IgA Nephropathy or other conditions. ^{1 2 4 5 6}

How is the drug telitacicept different from other treatments for IgA nephropathy?

Telitacicept is unique because it targets two specific proteins, BAFF and APRIL, which are involved in the immune system's role in IgA nephropathy. This dual-target approach helps reduce harmful immune activity in the kidneys, potentially improving outcomes for patients with this condition. ^{1 2 5 7 8}

What is the purpose of this trial?

This trial tests an injectable medication called Telitacicept on patients with a kidney disease known as IgA nephropathy. The medication aims to help by adjusting the immune system to reduce kidney damage.

Eligibility Criteria

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

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

Treatment Details

Interventions

• Telitacicept

Participant Groups

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

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Role of telitacicept in the treatment of IgA nephropathy. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Randomized Phase II JANUS Study of Atacicept in Patients With IgA Nephropathy and Persistent Proteinuria. [2022]

3. Australia pubmed.ncbi.nlm.nih.gov

Immunosuppressive treatments for immunoglobulin A nephropathy: a meta-analysis of randomized controlled trials. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Corticosteroids in IgA nephropathy: a randomised controlled trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Progression of IgA nephropathy under current therapy regimen in a Chinese population. [2021]

6. Netherlands 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. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Telitacicept for autoimmune nephropathy. [2023]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Agents in IgA Nephropathy: An Update Network Meta-Analysis. [2019]