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Monoclonal Antibodies

Daratumumab for Lupus Nephritis

Phase 2
Recruiting
Led By Fernando Fervenza, MD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years of age
Diagnosis of SLE according to current American College of Rheumatology (ACR) criteria
Must not have
Unable to provide consent
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after first infusion of daratumumab
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing daratumumab, a medication that helps the immune system, in patients with active lupus nephritis. The goal is to see if it can help these patients by reducing kidney damage caused by their disease.

Who is the study for?
Adults with active lupus nephritis, confirmed by biopsy and proteinuria, can join this trial. They must have a certain level of kidney function (eGFR ≥ 30 ml/min/SA) and meet specific criteria for systemic lupus erythematosus. Excluded are those on high-dose steroids, pregnant or breastfeeding women, individuals with hepatitis B/C or HIV, severe anemia or low platelets, recent immunosuppressive therapy users, and anyone unable to consent.
What is being tested?
The trial is testing Daratumumab's ability to induce remission in patients with active lupus nephritis. Participants will receive the drug to see if it safely and effectively reduces their disease activity compared to standard treatments.
What are the potential side effects?
Potential side effects of Daratumumab may include infusion reactions like fever or chills; blood disorders such as anemia; infections due to immune system suppression; fatigue; nausea; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I have been diagnosed with lupus according to ACR criteria.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am unable to give my consent.
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I agree to use highly effective birth control for 12 months after my last dose.
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I have taken rituximab before and currently have no CD20 cells.
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I have not taken immunosuppressive drugs like cyclosporine, tacrolimus, or azathioprine in the last 3 months.
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I have been diagnosed with glaucoma.
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I agree to use highly effective contraception and not donate sperm for 12 months after the last dose.
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I have not taken cyclophosphamide in the last 6 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after first infusion of daratumumab
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months after first infusion of daratumumab for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Efficacy of daratumumab in inducing complete(CR) or partial(PR)
Lupus Nephritis
Secondary study objectives
Change in ds-DNA
Change in hematuria.
Improvement from proteinuria
+2 more

Side effects data

From 2024 Phase 3 trial • 498 Patients • NCT02136134
44%
Thrombocytopenia
38%
Peripheral sensory neuropathy
38%
Peripheral Sensory Neuropathy
32%
Anaemia
24%
Fatigue
22%
Diarrhoea
17%
Upper respiratory tract infection
17%
Upper Respiratory Tract Infection
16%
Constipation
15%
Insomnia
15%
Asthenia
13%
Cough
11%
Nausea
11%
Neuralgia
11%
Pyrexia
11%
Dizziness
10%
Back Pain
10%
Pneumonia
10%
Back pain
10%
Neutropenia
9%
Dyspnoea
8%
Oedema peripheral
8%
Oedema Peripheral
7%
Pain in extremity
7%
Hyperglycaemia
6%
Pain in Extremity
6%
Headache
6%
Arthralgia
6%
Paraesthesia
6%
Bronchitis
5%
Bone pain
5%
Epistaxis
5%
Bone Pain
5%
Decreased Appetite
5%
Hypocalcaemia
5%
Dyspepsia
5%
Leukopenia
5%
Hypokalaemia
5%
Decreased appetite
4%
Lymphopenia
4%
Oedema
4%
Vomiting
4%
Hypotension
4%
Alanine aminotransferase increased
4%
Abdominal pain
4%
Nasopharyngitis
4%
Alanine Aminotransferase Increased
3%
Hypertension
3%
Rash
3%
Abdominal Pain Upper
3%
Conjunctivitis
3%
Hypophosphataemia
3%
Abdominal pain upper
3%
Influenza
2%
Muscle Spasms
2%
Musculoskeletal Chest Pain
2%
Aspartate aminotransferase increased
2%
Muscle spasms
2%
Urinary tract infection
2%
Myalgia
2%
Herpes zoster
2%
Musculoskeletal chest pain
2%
Herpes Zoster
1%
Pulmonary Embolism
1%
Weight Decreased
1%
Pulmonary embolism
1%
Myocardial infarction
1%
Dehydration
1%
Myocardial Infarction
1%
Lower Respiratory Tract Infection
1%
Abdominal Pain
1%
Orthostatic Hypotension
1%
General Physical Health Deterioration
1%
Condition aggravated
1%
General physical health deterioration
1%
Hyponatraemia
1%
Orthostatic hypotension
1%
Lower respiratory tract infection
1%
Syncope
1%
Productive cough
1%
Nasal congestion
1%
Respiratory failure
1%
Weight decreased
1%
Chills
1%
Gastroenteritis
1%
Sepsis
1%
Respiratory Failure
1%
Condition Aggravated
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bortezomib + Dexamethasone (Vd)
Daratumumab + Bortezomib and Dexamethasone (DVd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: DaratumumabExperimental Treatment1 Intervention
Subjects diagnosed with lupus nephritis will receive Daratumumab once weekly for 8 weeks and then once every 2 weeks for 8 additional does (+/- 4 days). Subjects will be followed for a total of 24 months (18 months after the last daratumumab administration).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~2380

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,343 Previous Clinical Trials
3,062,340 Total Patients Enrolled
Fernando Fervenza, MDPrincipal Investigator - Mayo Clinic
Mayo Clinic Hospital-Rochester Saint Marys Campus
Pontificia University Catol Do Rio Grande Do Sul (Medical School)
Mayo Grad School Med/Mayo Fndn (Residency)
4 Previous Clinical Trials
96 Total Patients Enrolled
Fernando C FervenzaPrincipal InvestigatorMayo Clinic

Media Library

Daratumumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04868838 — Phase 2
Lupus Nephritis Research Study Groups: Daratumumab
Lupus Nephritis Clinical Trial 2023: Daratumumab Highlights & Side Effects. Trial Name: NCT04868838 — Phase 2
Daratumumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04868838 — Phase 2
~4 spots leftby Jul 2026
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