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Monoclonal Antibodies
Daratumumab for Lupus Nephritis
Phase 2
Recruiting
Led By Fernando C Fervenza
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months after first infusion of daratumumab
Awards & highlights
Study Summary
This trial will test if daratumumab is safe and effective in treating lupus nephritis.
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.Check my eligibility
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.See study design
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 belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with lupus according to ACR criteria.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months after first infusion of daratumumab
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months after first infusion of daratumumab
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Efficacy of daratumumab in inducing complete(CR) or partial(PR)
Lupus Nephritis
Secondary outcome measures
Change in ds-DNA
Change in hematuria.
Improvement from proteinuria
+2 moreSide effects data
From 2024 Phase 3 trial • 498 Patients • NCT0213613460%
Thrombocytopenia
50%
Peripheral sensory neuropathy
47%
Peripheral Sensory Neuropathy
36%
Upper respiratory tract infection
36%
Diarrhoea
29%
Cough
28%
Anaemia
23%
Fatigue
23%
Upper Respiratory Tract Infection
23%
Constipation
21%
Back pain
20%
Arthralgia
20%
Oedema peripheral
19%
Neutropenia
19%
Dyspnoea
18%
Insomnia
17%
Pyrexia
16%
Oedema Peripheral
15%
Nausea
14%
Lymphopenia
14%
Pain in extremity
14%
Nasopharyngitis
14%
Bronchitis
14%
Neuralgia
13%
Back Pain
13%
Dizziness
12%
Decreased appetite
12%
Vomiting
12%
Headache
12%
Hypertension
11%
Conjunctivitis
11%
Asthenia
11%
Pneumonia
11%
Hypokalaemia
10%
Muscle spasms
10%
Musculoskeletal chest pain
9%
Urinary tract infection
9%
Leukopenia
9%
Bone pain
9%
Decreased Appetite
9%
Hyperglycaemia
9%
Pain in Extremity
9%
Bronchospasm
8%
Weight decreased
8%
Muscle Spasms
8%
Abdominal pain upper
8%
Alanine aminotransferase increased
7%
Hypophosphataemia
7%
Herpes zoster
7%
Influenza
7%
Hypocalcaemia
7%
Alanine Aminotransferase Increased
7%
Rash
6%
Musculoskeletal Chest Pain
6%
Myalgia
6%
Aspartate aminotransferase increased
6%
Nasal congestion
6%
Abdominal pain
5%
Bone Pain
5%
Hypotension
5%
Abdominal Pain Upper
5%
Weight Decreased
5%
Chills
5%
Productive cough
5%
Throat irritation
5%
Herpes Zoster
5%
Oedema
5%
Paraesthesia
5%
Epistaxis
4%
Dyspepsia
2%
Atrial fibrillation
2%
Acute kidney injury
2%
Sepsis
2%
Atrial Fibrillation
1%
Acute myocardial infarction
1%
Pneumonia cytomegaloviral
1%
Pleural effusion
1%
Rib fracture
1%
Lower Respiratory Tract Infection
1%
Pulmonary sepsis
1%
Febrile neutropenia
1%
Pulmonary Sepsis
1%
Hypercalcaemia
1%
Pneumonia Cytomegaloviral
1%
Cardiac failure congestive
1%
Acute coronary syndrome
1%
Lower respiratory tract infection
1%
Hip fracture
1%
Angina unstable
1%
Cerebrovascular accident
1%
Ischaemic stroke
1%
Bronchitis chronic
1%
Squamous cell carcinoma of skin
1%
Humerus fracture
1%
Respiratory failure
1%
Gastroenteritis
1%
Pathological fracture
1%
Femur fracture
1%
Ischaemic Stroke
1%
Respiratory Failure
1%
Pathological Fracture
1%
Febrile Neutropenia
1%
Cardiac Failure Congestive
1%
Bronchopneumonia
1%
Femur Fracture
1%
Humerus Fracture
1%
Acute Kidney Injury
1%
Pleural Effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Daratumumab + Bortezomib and Dexamethasone (DVd)
Bortezomib + Dexamethasone (Vd)
Switch From Bortezomib + Dexamethasone (Vd) to Daratumumab Monotherapy
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
~1990
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,213 Previous Clinical Trials
3,766,999 Total Patients Enrolled
Fernando C FervenzaPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.You have hepatitis B or C, or HIV.You have severe anemia with low hemoglobin levels.You have more than 500 milligrams of protein in your urine over a 24-hour period.I have been diagnosed with lupus according to ACR criteria.I am unable to give my consent.I do not have any health conditions that would make it unsafe for me to take a new drug.I have been on corticosteroids for more than 2 weeks but take less than or equal to 10 mg of prednisone or its equivalent.I agree to use highly effective birth control for 12 months after my last dose.I have taken rituximab before and currently have no CD20 cells.I have not taken immunosuppressive drugs like cyclosporine, tacrolimus, or azathioprine in the last 3 months.I am 18 years old or older.My kidney biopsy confirmed I have a specific type of lupus nephritis.I am taking no more than 1500mg/day of MMF.Your kidney function is normal, with an eGFR of at least 30 ml/min/SA.Your blood platelet count is less than 100,000.I have been diagnosed with glaucoma.I agree to use highly effective contraception and not donate sperm for 12 months after the last dose.I have not taken cyclophosphamide in the last 6 months.
Research Study Groups:
This trial has the following groups:- Group 1: Daratumumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What medical applications does Daratumumab generally have?
"Daratumumab is regularly utilized as a biological response modifier to mediate various medical ailments, such as refractory multiple myeloma and post-cell transplant relapses."
Answered by AI
Has Daratumumab obtained governmental endorsement from the Food and Drug Administration?
"The safety of Daratumumab was rated a 2 since this is only in Phase 2, and hence the data collected thus far has not established efficacy but does suggest general safety."
Answered by AI
What are the projected consequences this research will produce?
"The primary outcome of this medical trial evaluated over a 12-month period following the initial infusion of Daratumumab will be assessed for efficacy in terms of complete (CR) or partial response (PR). Secondary outcomes include changes to ds-DNA, hematuria and proteinuria. Specifically, researchers are monitoring improvement from baseline values as measured by international units per milliliter (IU/mL), urinalysis and milligrams per 24 hours respectively."
Answered by AI
Are any new participants being enrolled for the research at this juncture?
"Yes, the information available on clinicaltrials.gov confirms that this research is currently seeking participants. It was initially advertised on April 20th 2021 and it has been recently updated as of August 26th 2022. The investigators are attempting to recruit 12 people from a single site."
Answered by AI
To what extent have prior trials been conducted with Daratumumab?
"Presently, there are 140 clinical trials for Daratumumab with 26 in the final stage of testing. Most of them can be found in Harrison, New york; however numerous other cities have running studies on this medication as well."
Answered by AI
How many participants are taking part in this clinical experiment?
"Affirmative. Evidence on clinicaltrials.gov implies that the trial is currently seeking participants, which was initially posted on April 20th 2021 and updated as recently as August 26th 2022. The study requires 12 people across a single research centre to complete it."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What site did they apply to?
Mayo Clinic in Rochester
What portion of applicants met pre-screening criteria?
Met criteria
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