Clinical trial NCT04868838: Daratumumab to Treat Active Lupus Nephritis
Official title: A Phase 2 Open-label Trial Evaluating the Efficacy and Safety of Daratumumab in Treatment of Patients with Active Lupus Nephritis
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Lupus Nephritis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-05-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to study the safety and efficacy of daratumumab in inducing complete or partial remission in patients with active lupus nephritis.


Eligibility criteria: 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.

Primary outcomes:
measure: Efficacy of daratumumab in inducing complete(CR) or partial(PR) renal remission in patients with active class III or IV Lupus Nephritis
timeFrame: 12 months after first infusion of Daratumumab
measure: Efficacy of daratumumab in inducing complete(CR) or partial(PR)
timeFrame: 12 months after first infusion of Daratumumab
Secondary outcomes:
measure: Safety of daratumumab in patients with active class III/IV LN.
timeFrame: 24 months after first infusion of Daratumumab
measure: Improvement from proteinuria
timeFrame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab
measure: Change in hematuria.
timeFrame: Baseline,6, 12, 18 and 24 months after first infusion of Daratumumab
measure: Improvement in eGFR
timeFrame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab
measure: Change in ds-DNA
timeFrame: Baseline, 6, 12, 18 and 24 months after first infusion of Daratumumab
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Fernando Fervenza, MD
role: PRINCIPAL_INVESTIGATOR
References: