All > Lupus Nephritis > Lupus

Daratumumab for Lupus Nephritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MNLupus NephritisDaratumumab - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will test if daratumumab is safe and effective in treating lupus nephritis.

Eligible Conditions
  • Lupus Nephritis

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Alirocumab
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Daratumumab

Study Objectives

2 Primary · 5 Secondary · Reporting Duration: 12 months after first infusion of Daratumumab

Month 12
Efficacy of daratumumab in inducing complete(CR) or partial(PR)
Lupus Nephritis
Month 24
Safety of daratumumab in patients with active class III/IV LN.
Month 24
Change in ds-DNA
Improvement from proteinuria
Improvement in eGFR
Month 24
Change in hematuria.

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

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1
Alirocumab
2
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Side Effects for

KdD - Carfilzomib, Dexamethasone and Daratumumab
37%Thrombocytopenia
33%Anaemia
31%Diarrhoea
30%Hypertension
29%Upper respiratory tract infection
24%Fatigue
19%Dyspnoea
18%Nausea
18%Insomnia
17%Pyrexia
17%Cough
16%Bronchitis
16%Back pain
14%Neutropenia
13%Headache
12%Vomiting
12%Pneumonia
12%Muscle spasms
11%Oedema peripheral
9%Decreased appetite
9%Hyperglycaemia
9%Respiratory tract infection
9%Lymphopenia
9%Asthenia
9%Nasopharyngitis
8%Neuropathy peripheral
8%Arthralgia
7%Productive cough
7%Infusion related reaction
7%Constipation
7%Influenza
7%Dizziness
6%Peripheral sensory neuropathy
6%Leukopenia
6%Chills
6%Hypokalaemia
6%Pain in extremity
6%Rash
5%Urinary tract infection
5%Conjunctivitis
4%Sepsis
4%Oedema
2%Atrial fibrillation
2%Lower respiratory tract infection
2%Septic shock
2%Acute kidney injury
2%Plasma cell myeloma
2%Pulmonary embolism
2%Pulmonary oedema
1%Plasmacytoma
1%Syncope
1%Osteonecrosis of jaw
1%Sudden death
1%Blood creatinine increased
1%Pulmonary hypertension
1%Respiratory failure
1%Febrile neutropenia
1%Thrombotic thrombocytopenic purpura
1%Cardiac failure acute
1%Cardiac failure
1%Myocardial ischaemia
1%Atrial flutter
1%Cataract
1%Bacteraemia
1%Upper gastrointestinal haemorrhage
1%Hepatic function abnormal
1%Lung infection
1%Device related infection
1%Respiratory syncytial virus infection
1%Tumour lysis syndrome
1%Viral infection
1%Overdose
1%Posterior reversible encephalopathy syndrome
1%Interstitial lung disease
1%Pleural effusion
1%Pneumonitis
1%Cardiac arrest
1%Acute myocardial infarction
1%Cerebrovascular accident
This histogram enumerates side effects from a completed 2022 Phase 3 trial (NCT03158688) in the KdD - Carfilzomib, Dexamethasone and Daratumumab ARM group. Side effects include: Thrombocytopenia with 37%, Anaemia with 33%, Diarrhoea with 31%, Hypertension with 30%, Upper respiratory tract infection with 29%.

Trial Design

1 Treatment Group

Daratumumab
1 of 1

Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Daratumumab · No Placebo Group · Phase 2

Daratumumab
Drug
Experimental Group · 1 Intervention: Daratumumab · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 months after first infusion of daratumumab

Who is running the clinical trial?

Mayo ClinicLead Sponsor
2,952 Previous Clinical Trials
3,447,773 Total Patients Enrolled
Fernando C FervenzaPrincipal InvestigatorMayo Clinic

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Mayo Clinic in Rochester100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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