Zanubrutinib in Participants With Active Proliferative Lupus Nephritis

  • STATUS
    Recruiting
  • End date
    Aug 5, 2023
  • participants needed
    200
  • sponsor
    BeiGene
Updated on 5 May 2022
nephritis
24-hour urine protein test

Summary

The primary objective of this study is to evaluate the efficacy of zanubrutinib added to standard of care as measured by complete renal response for participants with active proliferative lupus nephritis

Details
Condition Lupus Nephritis
Treatment Placebo, Zanubrutinib
Clinical Study IdentifierNCT04643470
SponsorBeiGene
Last Modified on5 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Clinical diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics 2012 criteria
ISN/RPS 2003 Class III/IV lupus nephritis [Type III(A), III (A+C), IV (A), and IV (A+C)], with or without Class V, as confirmed by a renal biopsy
Positive antinuclear antibodies, positive anti-dsDNA autoantibody, and/or positive anti Smith autoantibody at screening
Has 24-hour urine protein excretion > 1.0 g at screening

Exclusion Criteria

Exclusion criteria related to systemic lupus erythematous and other diseases
Glomerulonephritis caused by reasons other than systemic lupus erythematous
Sclerosis in >50% of glomeruli on renal biopsy
Any other inflammatory diseases that might confound the assessments of efficacy, including but not limited to rheumatoid arthritis, myositis, vasculitis, or overlapping syndrome
Severe extrarenal SLE, including but not limited to pulmonary arterial hypertension, severe myocarditis, severe central nervous system lupus (such as neuropsychiatric SLE, seizures, psychosis, transverse myelitis, central nervous system vasculitis and optic neuritis), etc
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note