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Monoclonal Antibodies
Daxdilimab for Lupus Nephritis
Phase 2
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of proliferative LN based on a renal biopsy obtained within 6 months prior to signing the informed consent form (ICF) or during the Screening Period: Class III (± class V) or class IV (± class V) LN according to the World Health Organization (WHO) or 2003 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification (based on local evaluation of renal biopsy), Urine protein to creatinine ratio ≥113.17 mg/mmol, obtained via a 24-hour urine collection at Screening, Estimated glomerular filtration rate ≥35 mL/min/1.73 m2, Negative serum beta-human chorionic gonadotropin test at Screening (females of childbearing potential only)
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 48 to week 52
Awards & highlights
Study Summary
This trial will test a new drug to see if it helps with lupus nephritis and is safe to use.
Who is the study for?
Adults aged 18-80 with active proliferative lupus nephritis, who meet specific criteria including a recent biopsy confirming the diagnosis and certain lab results. They must be able to follow the trial protocol and have no history of severe infections or other kidney diseases that could affect the study.Check my eligibility
What is being tested?
The trial is testing Daxdilimab against a placebo in patients with lupus nephritis. It's a phase 2 study where participants are randomly assigned to either receive Daxdilimab or saline, without knowing which one they're getting, to compare effectiveness and safety.See study design
What are the potential side effects?
Potential side effects may include reactions related to immune system suppression such as increased risk of infection, possible allergic responses to the drug components, infusion-related reactions, and any unforeseen impacts on organ function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have been diagnosed with a certain type of kidney disease based on a recent kidney biopsy, along with specific levels of protein in your urine and kidney function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 48 to week 52
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 48 to week 52
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Proportion of participants achieving complete renal response (CRR) at Week 48 and sustained through Week 52.
Secondary outcome measures
Anti-Drug Antibody (ADA) rate.
Body Weight Changes
Therapeutic procedure
+2 moreTrial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Daxdilimab Arm 2Experimental Treatment1 Intervention
Daxdilimab injections over a total of 104 weeks
Group II: Daxdilimab Arm 1Experimental Treatment1 Intervention
Daxdilimab injections over a total of 104 weeks
Group III: PlaceboPlacebo Group1 Intervention
Placebo injections over a total of 104 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daxdilimab
2022
Completed Phase 2
~30
Find a Location
Who is running the clinical trial?
AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,669 Total Patients Enrolled
Horizon Therapeutics Ireland DACLead Sponsor
20 Previous Clinical Trials
2,457 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,112 Total Patients Enrolled
2 Trials studying Lupus Nephritis
44 Patients Enrolled for Lupus Nephritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I cannot tolerate low doses of MMF or a similar medication.I was diagnosed with Class V membranous lupus nephritis based on a recent kidney biopsy.You have a condition that weakens your immune system, like HIV infection or having had your spleen removed.I have not been on dialysis in the past year and do not expect to need it soon.You meet the specific medical guidelines for diagnosing systemic lupus erythematosus.You have been diagnosed with a certain type of kidney disease based on a recent kidney biopsy, along with specific levels of protein in your urine and kidney function.I have stopped my immunosuppressants, biologics, and DMARDs as required.I do not have active hepatitis, TB, severe herpes, or any serious infections.I am between 18 and 80 years old.I haven't had major heart problems like a heart attack in the last 6 months.I haven't had cancer in the last 5 years, except for specific skin cancers or cervical cancer that were treated.I do not have kidney diseases that could affect my lupus nephritis assessment.I have not received a live vaccine in the last 4 weeks.Your blood tests show high levels of certain antibodies that indicate an autoimmune disease.I have had allergic reactions to certain medications or treatments before.
Research Study Groups:
This trial has the following groups:- Group 1: Daxdilimab Arm 1
- Group 2: Daxdilimab Arm 2
- Group 3: Placebo
Awards:
This trial has 0 awards, including: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 is the aggregate number of participants in this experiment?
"Affirmative. Information hosted on clinicaltrials.gov supports the fact that this medical study is actively searching for patients, with an initial posting date of November 1st 2022 and a last update date also being November 1st 2022. 210 participants are required from one centre in order to complete the trial."
Answered by AI
Who is qualified to take part in this trial?
"Eligible candidates for this trial must be within the 18-80 year old range and possess lupus nephritis. This study is recruiting around 210 patients total."
Answered by AI
Does this trial extend to individuals past the age of twenty?
"For this study, only participants over the age of majority and under 80 are eligible to be enrolled."
Answered by AI
Are there still openings available for this clinical exploration?
"Affirmative. Clinicaltrials.gov records indicate that this ongoing clinical trial, which was initially published on November 1st 2022, is actively seeking participants. At least 210 individuals are needed from a single medical centre."
Answered by AI
What safety parameters have been established for Part 1 of the Daxdilimab protocol?
"The safety of Daxdilimab Arm 1 was rated 2 in our team's estimation, due to Phase 2 clinical trial data indicating a certain level of safety but no established evidence for its efficacy."
Answered by AI
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