Rituximab plus Belimumab for Lupus Nephritis (CALIBRATE Study)

  • STATUS
    Recruiting
  • sponsor
    NIAID
Updated on 25 March 2021

Summary

Rituximab plus Belimumab for Lupus Nephritis (CALIBRATE Study)

Description

Lupus nephritis is a severe form of systemic lupus erythematosus (SLE) with active disease in the kidneys. SLE is a complex disease in which the body's own immune system attacks some of the body parts: the skin, the joints, the kidneys, the nervous system, the heart, the lungs and the blood. Treatment for SLE usually involves drugs that are designed to block the immune system attacks. When SLE affects the kidneys (nephritis), stronger immune suppressing treatment is usually needed.

In this experimental study, researchers will try to find out if treatment of lupus nephritis with a combination of rituximab and cyclophosphamide (CTX), or a combination of rituximab and CTX followed by treatment with belimumab is safe and if this drug combination can block the immune system attacks.

For more information, visit www.calibratestudy.org

Details
Clinical Study IdentifierTX140498
SponsorNIAID
Last Modified on25 March 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female, aged 18 years or older
Diagnosis of systemic lupus erythematosus (SLE)
Active proliferative lupus nephritis

Exclusion Criteria

New onset lupus nephritis, defined as lupus nephritis for which the participant has not yet been treated with either mycophenolate mofetil or cyclophosphamide
Pregnant or breastfeeding
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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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.

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

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