Ravulizumab for Lupus Nephritis

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Clinical Study Site, Stanford, CALupus Nephritis+1 MoreRavulizumab - Drug
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to see if it's safe and effective for treating lupus nephritis or IgA nephropathy.

Eligible Conditions
  • Lupus Nephritis
  • IgA Nephropathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: Week 14, Week 26, and Week 50

Baseline through Week 50
LN Cohort: Percentage Of Participants With Extrarenal Systemic Lupus Erythematosus Flare
LN Cohort: Percentage Of Participants With Renal Flare
LN Cohort: Time To Urine Protein To Creatinine Ratio < 0.5 g/g
Baseline, Week 26
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26 Assessed Using 24-hour Urine Collections
Week 50
Both Cohorts: Change In Estimated Glomerular Filtration Rate (eGFR) From Baseline At Week 26 And Week 50
Baseline, Week 50
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50 Assessed Using 24-hour Urine Collections
Week 50
LN Cohort: Percentage Of Participants Achieving Corticosteroid Taper To 7.5 mg/day
Week 50
IgAN Cohort: Percentage Of Participants Meeting The Criteria For Partial Remission
LN Cohort: Percentage Of Participants Meeting The Criteria For Complete Renal Response
LN Cohort: Percentage Of Participants Meeting The Criteria For Partial Renal Response

Trial Safety

Safety Progress

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

Trial Design

4 Treatment Groups

Ravulizumab: LN Cohort
1 of 4
Ravulizumab: IgAN Cohort
1 of 4
Placebo: LN Cohort
1 of 4
Placebo: IgAN Cohort
1 of 4

Experimental Treatment

Non-Treatment Group

120 Total Participants · 4 Treatment Groups

Primary Treatment: Ravulizumab · Has Placebo Group · Phase 2

Ravulizumab: LN CohortExperimental Group · 2 Interventions: Ravulizumab, Background Therapy · Intervention Types: Drug, Other
Ravulizumab: IgAN CohortExperimental Group · 2 Interventions: Ravulizumab, Background Therapy · Intervention Types: Drug, Other
Placebo: LN CohortPlaceboComparator Group · 2 Interventions: Placebo, Background Therapy · Intervention Types: Drug, Other
Placebo: IgAN CohortPlaceboComparator Group · 3 Interventions: Ravulizumab, Placebo, Background Therapy · Intervention Types: Drug, Drug, Other
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ravulizumab
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: week 14, week 26, and week 50

Who is running the clinical trial?

AlexionLead Sponsor
234 Previous Clinical Trials
39,178 Total Patients Enrolled
1 Trials studying Lupus Nephritis
126 Patients Enrolled for Lupus Nephritis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
38,378 Total Patients Enrolled
1 Trials studying Lupus Nephritis
126 Patients Enrolled for Lupus Nephritis

Eligibility Criteria

Age 18 - 75 · All Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have active lymph nodes that need to be treated with medication that suppresses the immune system.

Frequently Asked Questions

What do we know about Ravulizumab from other scientific research?

"At present, there are 16 ongoing clinical trials researching ravulizumab. Of these, 13 are in phase 3. While several of the trials for ravulizumab are based in Whittier, California, there are 842 locations running clinical trials for ravulizumab globally." - Anonymous Online Contributor

Unverified Answer

Have there been other tests like this one before?

"Ravulizumab has been researched since 2016. The earliest trial was completed in 2016 and was sponsored by Alexion Pharmaceuticals. Following the first trial in 2016, which involved 270 participants, Ravulizumab received its Phase 3 drug approval. Today there are 16 active studies for Ravulizumab across 193 cities and 31 countries worldwide." - Anonymous Online Contributor

Unverified Answer

Does this experiment only allow those under 50 to participate?

"This study's requirements for eligible participants are that they must be between 18 and 75 years old. Out of the 567 total clinical trials, 59 are specifically for minors while 508 cater to adults over 65." - Anonymous Online Contributor

Unverified Answer

How many total hospitals are participating in this research project?

"You can participate in this study at any of the 22 sites, which include locations such as Salt Lake City, S. Gate and Dallas. To limit travel time and inconvenience, please select the site that is closest to you." - Anonymous Online Contributor

Unverified Answer

Are recruitment and enrollment still ongoing for this research project?

"That is correct. The information on clinicaltrials.gov affirms that this study, which began recruiting on December 11th 2020, is still looking for participants. They are aiming to have 120 patients at 22 different locations." - Anonymous Online Contributor

Unverified Answer

What are the conditions that ravulizumab has been most effective in treating?

"Ravulizumab is an effective medical intervention for disease activity, and can also help patients that suffer from conditions including hemolysis, thrombotic microangiopathies, atypical hemolytic uremic syndrome." - Anonymous Online Contributor

Unverified Answer

Has the federal government given its stamp of approval to Ravulizumab?

"Because there is only preliminary data supporting its safety, Ravulizumab was given a score of 2." - Anonymous Online Contributor

Unverified Answer

How many test subjects are in this experiment?

"That is correct. The clinical trial listing on the website says that this study is actively recruiting patients at 22 locations. They are looking to enroll 120 individuals in total." - Anonymous Online Contributor

Unverified Answer

Would I be a good candidate for this research?

"Eligible patients for this study must have lupus nephritis, be aged 18-75, and meet the following criteria: being vaccinated against meningococcal infection, having proteinuria ≥1 (gram [g]/day or g/g), clinically active LN that requires/is receiving immunosuppression induction treatment, vaccinated for Haemophilus influenzae type b (Hib) and Streptococcus pneumoniae according to national/local regulatory requirements, diagnosis of active focal or diffuse proliferative LN Class III or IV, diagnosis of primary IgAN, compliance with stable and optimal dose of ren" - 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.