Active not recruitingPHASE1, PHASE2INTERVENTIONAL

Safety and Tolerability of BION-1301 in Healthy Volunteers and Adults With IgA Nephropathy (IgAN)

This research is looking into a new medicine, BION-1301, to treat IgA Nephropathy (IgAN), a condition that affects the kidneys. The study has several parts. It started by checking the safety and how well BION-1301 was tolerated in healthy people, using single and multiple doses. Now, it's exploring these same things in adults who have IgAN. Researchers are also trying to understand how the medicine works in the body and how it affects the disease. While the main studies are ending, a follow-up period for those who participated is still open. The goal is to see if this new medicine could be a helpful treatment option for IgAN in the future.

At a glance

Status

Active not recruiting

Phase

PHASE1, PHASE2

Sponsor

Novartis Pharmaceuticals

Enrolment target

103

Start

08 Apr 2019

Estimated completion

30 Apr 2026

IgA Nephropathy

What is this study about?

This study is investigating a new medication called BION-1301 for a kidney condition known as IgA Nephropathy (IgAN). IgAN happens when a type of antibody, called IgA, builds up in the kidneys, causing damage and potentially leading to serious kidney problems. The new medicine, BION-1301, aims to block a specific protein in the body that is thought to play a role in developing IgAN.

The research is happening in several stages. It began by giving BION-1301 to healthy volunteers in different doses to see if it was safe and how their bodies reacted to it. This initial work helped researchers understand the medicine better. Now, the study is focusing on people who actually have IgAN. Doctors want to see if the medicine is safe for them, how well they tolerate it, and if it has any effects on their kidney disease.

This is an important step in developing new treatments for IgAN. If BION-1301 proves to be safe and shows positive effects, it could potentially offer a new way to manage this kidney condition and improve the lives of those affected by it. There's also a follow-up period for some participants who finished the main part of the study.

Key takeaways

The study is testing a new medicine called BION-1301 for IgA Nephropathy (IgAN).
Its main goals are to check the medicine's safety and how well people tolerate it.
Earlier parts checked healthy volunteers; now it's focusing on adults with IgAN.
Participation includes regular clinic visits, tests, and receiving the study medicine.
You have the right to withdraw from the study at any time.
This research aims to find better treatments for IgAN.

Who may be eligible?

To be considered for this study, you generally need to be an adult, at least 18 years old. For women, if you could get pregnant, you would need to agree to use reliable birth control during the study and for about six months afterwards. Men would also need to follow specific birth control advice during the study to ensure safety.

If you have IgA Nephropathy, the study is looking for around 40 people like you. Certain medical conditions or habits might mean you can't join. For instance, if you've recently used certain drugs, donated blood, or have other serious health problems affecting your breathing, heart, or digestion, you might not be suitable. The research team will review your individual health information to see if this study is right for you.

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.

Are you 18 years old or older?
Do you have IgA Nephropathy?
Are you able to attend regular clinic visits?
Are you willing to use specific birth control if necessary?
Do you have any serious long-term health conditions (other than IgAN)? (Some might prevent you from joining)

Answer every question to see your result.

What does participation involve?

If you join this study, you would first have a full check-up to see if you meet all the requirements. If you do, you would receive the study medicine, BION-1301, or a placebo (a dummy medicine without any active ingredient). This medicine would be given to you in multiple doses over a period of time. You would have planned visits to the clinic for ongoing monitoring, which would include blood tests, urine tests, and other checks to see how you are responding and to make sure you are safe. After the main part of the study, there's a follow-up period to continue checking your health. The medical team will explain the exact schedule of visits and procedures, as well as the total length of your involvement.

Potential risks and benefits

Like all medicines, BION-1301 might have side effects, and the research team will explain these to you carefully. You would be closely monitored throughout the study to catch any problems early. Potential benefits could include helping scientists better understand IgA Nephropathy and, for those receiving the active medicine, possibly experiencing an improvement in your condition, although this is not guaranteed for a new treatment. Remember, joining any study is completely voluntary, and you are free to leave at any time without giving a reason, and this decision will not affect your usual medical care.

Locations (16)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Amicis Research Center
Verified postcode
Northridge, United States
Colorado Kidney Care, P.C.
Verified postcode
Denver, United States
Nephrology Associates of Central Florida
Verified postcode
Orlando, United States
Elixia Tampa, LLC
Verified postcode
Tampa, United States
New York Nephrology
Verified postcode
Clifton Park, United States
Chris Sholer, P.C.
Verified postcode
Oklahoma City, United States
Liberty Research Center
Verified postcode
Arlington, United States
Liberty Research Center
Verified postcode
Dallas, United States
Prolato Clinical Research Center
Verified postcode
Houston, United States
Soon Chun Hyang University Hospital Cheonan
Verified postcode
Cheonan, South Korea
Hallym University Sacred Heart Hospital
Verified postcode
Anyang-si, South Korea
National Health Insurance Service Ilsan Hospital
Verified postcode
Goyang-si, South Korea

Common questions

What is IgA Nephropathy (IgAN)?

IgA Nephropathy (IgAN) is a kidney disease where a type of protein, called IgA, builds up in the kidneys, which can lead to damage over time.

What is BION-1301?

BION-1301 is a new, investigational medicine being tested to see if it can treat IgA Nephropathy by targeting a specific protein involved in the disease.

Will I get the actual medicine or a dummy one?

In the earlier parts, some people received a dummy medicine (placebo). If you have IgAN and join, you will receive the active medicine, BION-1301.

How long will I be involved in the study?

The study involves regular visits over a period of time, followed by a lighter follow-up period. The exact duration will be explained by the study team.

Can I stop being part of the study if I change my mind?

Yes, you can choose to leave the study at any time, for any reason, without it affecting your ongoing medical care.