Daratumumab to Treat Active Lupus Nephritis

Overview

About this study

The purpose of this study is to assess the effectiveness and safety of daratumumab in inducing complete or partial remission in patients with active class III or IV (± V) lupus nephritis (LN) as measured by change in proteinuria and serum creatinine.

 

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

- Age ≥ 18 years of age.

- Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria.

- Renal biopsy confirming the diagnosis of active class III/IV (± class V) LN (based on
International Society of Nephrology/Renal Pathology Society (ISN/RPS) 2003) within 12
months of enrollment.

- Proteinuria ≥ 500 mg over 24 hours.

- eGFR ≥ 30 ml/min/SA.

- Subjects should be able to give informed consent.

Exclusion Criteria:

- Pregnancy.

- Hepatitis B or C, HIV

- Anemia with Hgb < 8.0 g/dL.

- Thrombocytopenia with platelet count < 100'000.

- Any other disease, metabolic dysfunction, physical examination finding, or clinical
laboratory finding giving reasonable suspicion of a disease or condition that
contraindicates the use of an investigational drug or that may affect the
interpretation of the results or render the patient at high risk from treatment
complication.

- Unable to provide consent.

- Patients receiving > 10 mg of oral prednisone or glucocorticoid equivalent if on
corticosteroids for > 2 weeks (patients would be allowed to be on > 10 mg of
prednisone or its oral equivalent as long as the duration is ≤ 2 weeks).

- Patients who had received immunosuppressive therapy including cyclosporine, tacrolimus
or azathioprine in the last 3 months.

- Patients who have received cyclophosphamide in the last 6 months.

- Patients who received rituximab previously with CD20 count of zero at the time of
enrollment.

- Patient are allowed to be on MMF at time of enrollment but no higher than total of
1500mg/day.

- For women who are not postmenopausal (≥ 12 months of non-therapy-induced amenorrhea)
or surgically sterile (absence of ovaries and/or uterus): agreement to remain
abstinent or use two adequate methods of contraception, including at least one method
with a failure rate of less than (<) 1 percent (%) per year, during the treatment
period and for at least 12 months after the last dose of study drug.

- For men: agreement to remain abstinent or use a condom plus an additional
contraceptive method that together result in a failure rate of < 1% per year during
the treatment period and for at least 12 months after the last dose of study drug and
agreement to refrain from donating sperm during this same period.

- Patients with diagnosis of glaucoma.

Eligibility last updated 7/8/22. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Fernando Fervenza, M.D., Ph.D.

Open for enrollment

Contact information:

Amber Stanton B.S.

(507) 293-7259

Stanton.Amber@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20511387

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