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Active not recruitingPHASE3INTERVENTIONAL

Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)

This study is looking for adults with a kidney condition called IgA Nephropathy (IgAN). IgAN can cause kidney damage, and one sign of this is too much protein in the urine. We are testing a new medicine called povetacicept to see if it can help reduce this protein and keep the kidneys working well. Half the participants will receive povetacicept, and the other half will receive a dummy medicine (placebo) that looks the same. Doctors will regularly check kidney function and protein levels. The aim is to find out if povetacicept is a safe and effective way to manage IgAN and protect your kidneys. We hope this research will lead to better treatments for people with IgAN.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Alpine Immune Sciences Inc, A Subsidiary of Vertex
Enrolment target
605
Start
30 Aug 2024
Estimated completion
30 Jan 2028

What is this study about?

This study is investigating a new medication called povetacicept for adults who have a kidney disease known as Immunoglobulin A Nephropathy, often shortened to IgAN. In IgAN, special proteins called immunoglobulins, specifically IgA, build up in the kidneys. Over time, this can lead to inflammation and damage, making it harder for the kidneys to filter waste from your blood.

One of the main signs of IgAN damage is proteinuria, which means there's too much protein in your urine. Healthy kidneys keep most protein in the blood, but damaged kidneys let it leak into the urine. This study aims to see if povetacicept can effectively lower the amount of protein in the urine and help maintain healthy kidney function for longer. By comparing povetacicept to a placebo (a dummy medicine), we can accurately understand its effects.

Finding new ways to treat IgAN is very important because while current treatments can help, there's a need for more effective options to slow down the disease and prevent kidney failure. This research could bring us closer to a new and improved treatment for people living with IgAN.

Key takeaways

  • This study is for adults with a kidney condition called IgA Nephropathy.
  • It's testing a new medicine, povetacicept, against a dummy medicine (placebo).
  • The main goals are to reduce protein in the urine and protect kidney function.
  • Participants will have regular medical check-ups and blood/urine tests.
  • Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be an adult aged 18 or older and have a confirmed diagnosis of IgA Nephropathy through a kidney biopsy. You also need to have certain levels of protein in your urine, showing your kidneys are affected, and your kidney function must be at a particular level, not too severely reduced.

There are also some things that would mean you can't join. For example, if you've recently had other treatments that affect your immune system, like certain steroids or other immune-suppressing medicines, you might not be able to take part. Also, if your kidney function has worsened very quickly in the past few months, the study might not be suitable for you.

Your doctor will check all the specific details to see if this study is the right fit for your health situation.

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. Are you 18 years old or older?
  2. Have you been diagnosed with IgA Nephropathy by a kidney biopsy?
  3. Do you have a certain amount of protein in your urine?
  4. Is your kidney function (eGFR) at a specific level, not too low?
  5. Have you avoided certain immune-suppressing treatments recently?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you will either receive the new medicine, povetacicept, or a dummy medicine called a placebo. You won't know which one you are getting, and neither will your study doctor, until the study is over. You'll need to attend regular clinic visits where the study team will monitor your health, check your kidney function through blood tests, and measure the amount of protein in your urine. These checks will help doctors understand how the medicine is working and whether it's safe for you. The total duration of your participation in the study will be explained in detail by the study team, including how often you'll need to visit and for how long. You will also have follow-up appointments after you stop taking the study medicine to ensure your well-being.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving a new investigational medicine for your IgAN and closer medical monitoring of your condition. However, there are also potential risks, as the new medicine might have side effects that are not yet fully known. The dummy medicine (placebo) will not treat your IgAN. All known risks will be fully explained to you before you decide to join. Remember, participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without affecting your usual medical care.

Locations (318)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Apogee Clinical Research, LLC
    Verified postcode
    Huntsville, United States
  • Arizona Kidney Disease and Hypertension Center - Thomas Office
    Verified postcode
    Phoenix, United States
  • Arizona Kidney Disease and Hypertension Center - Tuscon
    Verified postcode
    Tucson, United States
  • West Coast Kidney
    Verified postcode
    Fremont, United States
  • The Medical Research Group, Inc. (FRENOVA)
    Verified postcode
    Fresno, United States
  • CARE Institute - Carabello Kidney
    Verified postcode
    Los Angeles, United States
  • Providence Medical Foundation - Orange
    Verified postcode
    Orange, United States
  • National Nephrology Alliance Research
    Verified postcode
    Riverside, United States
  • UC Davis Health
    Verified postcode
    Sacramento, United States
  • Zuckerberg San Francisco General Hospital and Trauma Center
    Verified postcode
    San Francisco, United States
  • University of California San Francisco (UCSF)
    Verified postcode
    San Francisco, United States
  • Western Nephrology
    Verified postcode
    Arvada, United States

Common questions

What is IgA Nephropathy?

IgA Nephropathy is a kidney disease where a specific protein called IgA builds up in the kidneys, leading to damage and problems filtering waste.

What is povetacicept?

Povetacicept is a new medicine being tested to see if it can help reduce protein in the urine and protect kidney function in people with IgA Nephropathy.

What is a placebo?

A placebo is a dummy medicine that looks exactly like the study medicine but contains no active ingredients. It helps doctors see if the real medicine is working.

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

No, neither you nor your study doctor will know which you are receiving until the study is finished. This is called 'blinding' and helps keep the study fair.

Can I stop participating at any time?

Yes, you are free to leave the study at any point, for any reason, and your decision will not affect your regular medical care.

How to find out more

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

Discussion

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