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Active not recruitingPHASE3INTERVENTIONAL

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

This research study is investigating a new medication called Obinutuzumab for people who have primary membranous nephropathy (pMN), a condition that affects the kidneys. This is a Phase 3 study, which means it’s one of the final steps before a new medicine might become widely available. Researchers want to find out how effective and safe Obinutuzumab is compared to a standard treatment called tacrolimus. They will also look at how the body uses and processes these medicines. The main goal is to see if Obinutuzumab can improve kidney function and reduce protein in the urine, offering a potentially better treatment option for pMN.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
Hoffmann-La Roche
Enrolment target
142
Start
25 Jun 2021
Estimated completion
21 Dec 2027

What is this study about?

This research study is focusing on a condition called primary membranous nephropathy, or pMN. This is a type of kidney disease where the tiny filters in your kidneys become damaged, leading to too much protein leaking into your urine. Over time, this can cause serious problems with your kidney function. The study aims to find a better way to treat pMN.

Researchers are comparing a new medicine called Obinutuzumab with an existing treatment, tacrolimus. Both medicines are designed to help reduce the damage to your kidneys and lower the amount of protein in your urine. They will also be looking closely at any side effects and how your body reacts to these treatments. This type of study, known as Phase 3, is a crucial step to determine if new treatments are better and safer than what is currently available.

The findings from this study could be very important for people living with primary membranous nephropathy. If Obinutuzumab proves to be effective and safe, it could offer a new and improved treatment option, potentially helping to protect kidney function and improve the quality of life for many patients.

Key takeaways

  • Exploring a new treatment (Obinutuzumab) for primary membranous nephropathy (pMN).
  • Comparing the new medicine to a standard treatment (tacrolimus).
  • Aims to improve kidney function and reduce protein in urine.
  • Participation involves regular clinic visits for monitoring and tests.
  • Open to adults aged 18-75 with specific kidney disease criteria.

Who may be eligible?

To join this study, adults between 18 and 75 years old must have been diagnosed with primary membranous nephropathy through a kidney biopsy. You'd also need to show a certain level of protein in your urine, even after receiving standard care for at least 3 to 6 months.

There are several reasons why someone might not be able to join. For example, if your kidney disease is caused by something else (not primary membranous nephropathy), or if you are pregnant or breastfeeding. You also can't have severe kidney problems requiring dialysis, uncontrolled diabetes, or certain other serious health issues or infections. If you've recently had major surgery or taken certain other medications, you might also not be able to take part.

The study also cannot include individuals who have reduced their protein in the urine by a lot in the last six months (50% or more), or who have a history of recent drug or alcohol abuse. The doctors involved will carefully check all these points to make sure the study is right and safe 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.

  1. Are you between 18 and 75 years old?
  2. Have you been diagnosed with primary membranous nephropathy through a kidney biopsy?
  3. Do you have a certain level of protein in your urine, even after 3-6 months of usual care?
  4. Are you NOT pregnant or breastfeeding?
  5. Have you NOT had a large reduction in urine protein (50% or more) in the last 6 months?
  6. Do you NOT have severe kidney problems needing dialysis or uncontrolled diabetes?
Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would be assigned to receive either the new medicine (Obinutuzumab) or a standard treatment (tacrolimus). You might also receive other common medications like methylprednisolone, acetaminophen, or diphenhydramine to help manage any potential side effects or for pain relief. The study would involve regular visits to the clinic for check-ups, blood tests, urine tests, and possibly other assessments. These visits are important to monitor your health, how the treatment is working, and to identify any side effects. The total duration of your participation would depend on the study's design, but it will involve ongoing check-ups for a period of time.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access a new treatment that might be more effective than current options for primary membranous nephropathy. However, there's no guarantee the new treatment will work for you, and it might have side effects that are not yet fully known. Any medication carries potential risks, and you would be closely monitored for these. You will be fully informed of all known benefits and risks before you decide to participate, and importantly, you are free to withdraw from the study at any time without giving a reason, and your medical care will not be affected.

Locations (50)

  • Kaiser Permanente - San Francisco Medical Center
    Verified postcode
    San Francisco, United States
  • University of Colorado in Denver-Anschutz Medical Campus
    Verified postcode
    Aurora, United States
  • Accel Research Sites; Mid-Florida Kidney and Hypertension Care
    Verified postcode
    Altamonte Springs, United States
  • University of Iowa
    Verified postcode
    Iowa City, United States
  • Henry Ford Hospital
    Verified postcode
    Detroit, United States
  • Mayo Clinic
    Verified postcode
    Rochester, United States
  • Columbia University Medical Center
    Verified postcode
    New York, United States
  • Nephrotex Research Group
    Verified postcode
    Dallas, United States
  • Organizacion Medica de Investigacion
    Verified postcode
    Buenos Aires, Argentina
  • CINME
    Verified postcode
    Buenos Aires, Argentina
  • Hospital Britanico Buenos Aires
    Verified postcode
    Buenos Aires, Argentina
  • Ser Servicos Especializados Em Reumatologia
    Verified postcode
    Salvador, Brazil

Common questions

What is primary membranous nephropathy?

It's a kidney disease where the filters in your kidneys are damaged, causing too much protein to leak into your urine.

What is Obinutuzumab?

It's a new medicine being tested in this study to see if it can help treat primary membranous nephropathy.

What phase is this study?

It's a Phase 3 study, meaning it's in the later stages of testing before a medicine might become available.

Will I know which treatment I'm getting?

In some studies, you might not know if you're getting the new medicine or the standard one, to make sure the results are fair.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your usual 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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