Active not recruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Efficacy and Safety of Obinutuzumab in Participants With ISN/RPS 2003 Class III or IV Lupus Nephritis

This research study is investigating a new treatment called obinutuzumab for individuals diagnosed with lupus nephritis, a serious condition where your immune system attacks your kidneys. Doctors are comparing obinutuzumab to a placebo (a dummy medicine) to see how effective and safe it is when given alongside standard care, which includes medicines like mycophenolate mofetil and steroids such as prednisone. This is a Phase 3 study, meaning it’s a later stage of research involving a larger number of patients, aiming to confirm the findings from earlier studies. The goal is to find out if obinutuzumab can improve kidney function and overall health for people with this type of lupus.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Hoffmann-La Roche

Enrolment target

271

Start

10 Aug 2020

Estimated completion

02 Mar 2031

Lupus Nephritis

What is this study about?

This study is all about helping people who have a condition called lupus nephritis. Lupus is an autoimmune disease, which means your body's immune system, which normally fights off infections, mistakenly attacks healthy parts of your own body. When lupus affects your kidneys, it's called lupus nephritis, and it can cause serious damage to these vital organs.

The main aim of this study is to test a new medicine called obinutuzumab. Researchers want to find out if adding obinutuzumab to the treatments you might already be taking for lupus nephritis (like steroids and mycophenolate mofetil) can make a real difference. They're particularly interested in whether it's safe and if it works better than a placebo, which looks like the study drug but doesn't contain any active medicine. This kind of comparison helps doctors understand the true effects of the new treatment.

This is a 'Phase 3' study, which is an important step in developing new medicines. It means the medicine has already been tested in earlier stages, and now a larger group of people are taking part to get more detailed information about its benefits and any possible side effects. The hope is that obinutuzumab could offer a new and effective way to manage lupus nephritis, helping to protect kidney function and improve quality of life for those affected.

Key takeaways

This study is for people with a specific kidney problem from lupus.
It's testing a new medicine, obinutuzumab, against a dummy medicine.
The goal is to see if obinutuzumab improves kidney health and is safe.
You would receive the study medicine alongside your current lupus treatments.
Regular health checks and doctor visits are part of taking part.
It's for people aged 18 to 75 who meet specific health requirements.

Who may be eligible?

To join this study, participants with lupus nephritis need to be between 18 and 75 years old. The lupus nephritis must be of a specific type (Class III or IV) that has been recently confirmed by a kidney biopsy, within the last six months. Also, your urine tests must show a certain level of protein, which is a common sign of kidney problems.

There are several reasons why someone might not be able to join. For example, if you are pregnant or breastfeeding, you won't be able to take part. Also, if your kidney problems are very severe, meaning you need dialysis or a kidney transplant, or if you have a current serious infection, you won't be suitable for the study.

It's also important that you haven't received certain other treatments for lupus recently, especially specific immune-suppressing medicines or similar drugs that target CD20 (like obinutuzumab). The study team will check all your medical history to make sure taking part is safe for you.

Quick self-check

Are you between 18 and 75 years old?
Do you have a diagnosis of lupus nephritis, specifically Class III or IV, confirmed by a recent kidney biopsy?
Are your urine tests showing a certain amount of protein?
Are you able to avoid pregnancy or breastfeeding for the duration of the study?
Have you not had certain other immune treatments in the last few months?
Do you currently have a severe active infection, or need dialysis or a kidney transplant?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you'll be given either the study medicine, obinutuzumab, or a placebo (a dummy medicine), alongside your usual treatments for lupus nephritis like mycophenolate mofetil and steroids. You'll have regular visits to the clinic so doctors can monitor your health, check how your kidneys are doing, and see if the study medicine is working. This will involve blood tests, urine tests, and sometimes other assessments.

This study will last for a certain period, and during that time, you'll need to follow the study schedule, including taking your medicines as instructed and attending all your appointments. There will also be follow-up appointments after the main treatment period to ensure your well-being. The exact number of visits and the full duration of your participation will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that might help your condition, potentially before it's widely available. It also contributes to medical knowledge, helping others in the future. However, there are potential risks, as with any medication. The study drug, obinutuzumab, or even the placebo, might cause side effects, and some may be serious. The study team will continuously monitor you for any problems and explain all known risks before you decide to join. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (74)

University of Alabama at Birmingham Medical Center
Birmingham, United States
Wallace Rheumatic Study Center
Beverly Hills, United States
Kaiser Permanente - Fontana
Fontana, United States
Kaiser Permanente - San Francisco Medical Center
San Francisco, United States
Stanford University Medical Center
Stanford, United States
Univ Colorado Health Sci Ctr
Aurora, United States
Yale Medical Group
New Haven, United States
University of Miami Miller School of Medicine
Miami, United States
Georgia Nephrology
Lawrenceville, United States
North Shore University Hospital
Manhasset, United States
NYU Langone Medical Center
New York, United States
Columbia University Medical Center
New York, United States

+62 more sites — see the official record for the full list.

Common questions

What is lupus nephritis?

Lupus nephritis is a serious kidney condition caused by lupus, where your immune system mistakenly attacks and damages your kidneys.

What is obinutuzumab?

Obinutuzumab is a new medicine being tested in this study to see if it can help treat lupus nephritis, working alongside your usual treatments.

What does 'placebo' mean?

A placebo is a 'dummy' medicine that looks like the real study drug but doesn't contain any active ingredients. It helps doctors compare the actual effects of the new medicine.

Can I still take my regular lupus medicines?

Yes, you will continue to take your standard lupus nephritis medicines, like mycophenolate mofetil and steroids, alongside the study drug or placebo.

How long will the study last?

The total duration of your participation, including treatment and follow-up, will be clearly explained by the study team during your initial conversations.