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Enrolling by invitationPHASE2, PHASE3INTERVENTIONAL

Trial of Sibeprenlimab in the Treatment of Immunoglobulin A Nephropathy (IgAN)

This study is checking the long-term safety and how well a medicine called sibeprenlimab works for people who have a kidney condition known as IgA Nephropathy (IgAN). Ignorance A Nephropathy is a chronic kidney disease where antibodies build up in the kidneys, which can cause them to become damaged over time. This particular trial is for people who have already taken part in previous studies of sibeprenlimab. The main goal is to see if taking this medicine for a longer period is safe and if it continues to be helpful for their kidney health. Participants will receive the medicine as an injection under the skin every four weeks.

At a glance

Status
Enrolling by invitation
Phase
PHASE2, PHASE3
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Enrolment target
600
Start
05 Apr 2022
Estimated completion
31 Dec 2029

What is this study about?

This study is looking into a medication named sibeprenlimab for a kidney condition called IgA Nephropathy (IgAN). IgAN is a disease where a certain type of antibody builds up in the kidneys, which can lead to damage over time. The main purpose of this particular study is to understand the long-term safety of sibeprenlimab and how well it continues to help people with IgAN.

This trial is specifically designed for individuals who have already participated in earlier studies of sibeprenlimab (known as trials 417-201-00007 or VIS649-201). If your doctor believes you could still benefit from this treatment, you might be invited to join. The researchers want to gather more information over a longer period to ensure the medication is safe and effective for ongoing use.

Participants in this study will receive sibeprenlimab as an injection under the skin every four weeks. By joining, you would be contributing valuable information that could help doctors better understand and treat IgAN in the future. The study is open-label, which means both you and your doctor will know you are receiving the active treatment.

Key takeaways

  • This study is for people with IgA Nephropathy who have already been in specific sibeprenlimab trials.
  • It aims to check the long-term safety and how well sibeprenlimab works.
  • The medicine is given as an injection under the skin once a month.
  • Your doctor must believe you would benefit from continuing the treatment.
  • You'll have regular check-ups to monitor your health and kidney function.
  • You can stop participating at any time.

Who may be eligible?

This study is only for people who have already been part of two specific earlier studies (called 417-201-00007 or VIS649-201) involving the same medicine, sibeprenlimab. To be considered, you must have completed most of the doses in those previous studies and had your final study visit without any major safety concerns. Importantly, your doctor must also believe that continuing to take sibeprenlimab could still be helpful for your IgA Nephropathy.

You also need to be able to understand what joining the study involves and be willing to give your written permission. It's important that you can reliably attend all appointments and follow the study instructions. The study is open to adults aged 18 and over.

You would not be able to join if you didn't finish one of the previous studies, or if you had serious side effects during those studies that your doctor thought were due to the medicine. Also, if you regularly didn't follow the rules of the previous studies, you wouldn't be eligible. Pregnant women or those who could become pregnant, or their partners, must agree to use effective contraception during the study and for a period afterwards.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Have I previously taken part in Trial 417-201-00007 or VIS649-201 for IgA Nephropathy?
  2. Did I complete that previous study without major safety issues related to the medicine?
  3. Does my kidney doctor think continuing sibeprenlimab would benefit my IgA Nephropathy?
  4. Am I at least 18 years old?
  5. Am I willing and able to attend all study appointments?
  6. If I am a woman who could get pregnant, or a man with a partner who could get pregnant, am I willing to use effective contraception during the study?
Answer every question to see your result.

What does participation involve?

If you join this study, you would continue to receive the study medication, sibeprenlimab. This medicine is given as an injection under the skin every four weeks.

The study aims to look at the long-term effects, so it will involve regular visits to the clinic for assessments. These visits will help doctors check your general health, how your kidneys are doing, and if you are experiencing any side effects. You'll have blood tests, urine tests, and possibly other checks to monitor your condition and the effects of the treatment. The total length of your participation would depend on the study design and your individual circumstances, but the aim is long-term follow-up.

Potential risks and benefits

Participating in this study might offer you the potential benefit of continuing a treatment that your doctor believes is helping your IgA Nephropathy. It also contributes important knowledge that could help others with this condition in the future. However, like all medicines, sibeprenlimab can have side effects, and while previous studies have looked at safety, this study aims to understand long-term safety. If you experience any worrying symptoms during the study, it's important to tell your medical team immediately. You are free to leave the study at any time, for any reason, without affecting your usual medical care.

Locations (158)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Clinical Research Site #336
    Verified postcode
    Birmingham, United States
  • Clinical Research Site #325
    Verified postcode
    Los Angeles, United States
  • Clinical Research Site #370
    Verified postcode
    Palo Alto, United States
  • Clinical Research Site #330
    Verified postcode
    Denver, United States
  • Clinical Research Site #323
    Verified postcode
    Lauderdale Lakes, United States
  • Clinical Research Site #373
    Verified postcode
    Atlanta, United States
  • Clinical Research Site #356
    Verified postcode
    Lawrenceville, United States
  • Clinical Research Site #369
    Verified postcode
    Boston, United States
  • Clinical Research Site #331
    Verified postcode
    Worcester, United States
  • Clinical Research Site #320
    Verified postcode
    Shelby, United States
  • Clinical Research Site #346
    Verified postcode
    Great Neck, United States
  • Clinical Research Site #350
    Verified postcode
    Columbus, United States

Common questions

What is IgA Nephropathy?

IgA Nephropathy is a kidney disease where antibodies called IgA build up in the kidneys. Over time, this can cause damage and make the kidneys less able to filter waste from your blood.

What is sibeprenlimab?

Sibeprenlimab is a medicine being tested to treat IgA Nephropathy. It's given as an injection under the skin.

Why is this study only for people who have been in other studies?

This study is designed to gather long-term information on the safety and effectiveness of sibeprenlimab. So, it's for people who have already used the medicine in earlier research trials and whose doctors think they could still benefit.

Will I know if I'm getting the real medicine?

Yes, this is an "open-label" study, which means you and your doctor will know that you are receiving sibeprenlimab, the active study medicine.

How often will I need to have the injection?

If you join the study, you would receive the sibeprenlimab injection under your skin every four weeks.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Trial of Sibeprenlimab in the Treatment of Immunoglobulin A …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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