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ALXN2050 for Kidney Disease

Phase 2
Recruiting
Research Sponsored by Alexion Pharmaceuticals, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, week 26, and week 50
Awards & highlights

Study Summary

This trial is testing a new drug, ALXN2050, to see if it's safe and effective in treating adults with Lupus Nephritis or IgA Nephropathy.

Who is the study for?
Adults aged 18-75 with Lupus Nephritis (LN) or IgA Nephropathy (IgAN), who meet specific diagnostic criteria, including certain levels of proteinuria and active disease requiring treatment. Participants must have stable blood pressure and kidney function, and not be planning a transplant or have other significant health issues.Check my eligibility
What is being tested?
The trial is testing ALXN2050 at two doses versus placebo in addition to standard care for LN or IgAN. It includes an initial evaluation period of 26 weeks, followed by an extended treatment period of 24 weeks, with the possibility of joining a longer open-label extension study.See study design
What are the potential side effects?
While specific side effects are not listed here, safety will be monitored throughout the study to track any adverse reactions participants may experience from ALXN2050 in comparison to the placebo.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, week 26, and week 50
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, week 26, and week 50 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26
Secondary outcome measures
Both Cohorts: Absolute Values And Change From Baseline In Plasma Concentration Of Bb Fragment Of Complement Factor B At Week 50
Both Cohorts: Absolute Values And Change From Baseline In Serum Alternative Pathway Activity At Week 50
Both Cohorts: Change From Baseline In Estimated Glomerular Filtration Rate (eGFR) At Week 26 And Week 50
+12 more

Trial Design

6Treatment groups
Experimental Treatment
Placebo Group
Group I: LN Cohort: ALXN2050 180 mgExperimental Treatment1 Intervention
Participants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
Group II: LN Cohort: ALXN2050 120 mgExperimental Treatment1 Intervention
Participants diagnosed with LN with an active flare will receive ALXN2050 in addition to standard-of-care background therapy.
Group III: IgAN Cohort: ALXN2050 180 mgExperimental Treatment1 Intervention
Participants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
Group IV: IgAN Cohort: ALXN2050 120 mgExperimental Treatment1 Intervention
Participants diagnosed with IgAN will receive ALXN2050 in addition to standard-of-care background therapy.
Group V: LN Cohort: PlaceboPlacebo Group1 Intervention
Participants diagnosed with LN with an active flare will receive matched placebo in addition to standard-of-care background therapy.
Group VI: IgAN Cohort: PlaceboPlacebo Group2 Interventions
Participants diagnosed with IgAN will receive matched placebo in addition to standard-of-care background therapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ALXN2050
2021
Completed Phase 1
~250

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
253 Previous Clinical Trials
41,132 Total Patients Enrolled
1 Trials studying Lupus Nephritis
120 Patients Enrolled for Lupus Nephritis
AlexionLead Sponsor
246 Previous Clinical Trials
39,207 Total Patients Enrolled
1 Trials studying Lupus Nephritis
120 Patients Enrolled for Lupus Nephritis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,353 Total Patients Enrolled
1 Trials studying Lupus Nephritis
120 Patients Enrolled for Lupus Nephritis

Media Library

Lupus Nephritis Research Study Groups: LN Cohort: ALXN2050 180 mg, LN Cohort: ALXN2050 120 mg, LN Cohort: Placebo, IgAN Cohort: ALXN2050 180 mg, IgAN Cohort: ALXN2050 120 mg, IgAN Cohort: Placebo

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are mature adults eligible for this type of research?

"The age range for this trial is 18-75 years old."

Answered by AI

How can I sign up for this clinical trial?

"This trial is looking for 126 patients, aged 18 to 75, who have lupus nephritis. In addition to meeting this broad criteria, potential participants must also satisfy the following: LN Cohort, Clinical diagnosis of SLE by 2019 American College of Rheumatology and European League Against Rheumatism criteria., Diagnosis of 2018 Revised International Society of Nephrology/Renal Pathology Society classification (active focal or diffuse proliferative LN Class III or IV) confirmed by biopsy obtained ≤ 6 months prior to Screening or during Screening Period. Participants may co-exhibit Class V disease."

Answered by AI

Are patients being actively recruited for this research project?

"That is correct. The 8 clinical trial sites are currently recruiting the 126 patients needed for the study. The original posting date was 1/14/2022, with the most recent edit on 10/11/2022."

Answered by AI

Where can people go to participate in this clinical trial?

"To limit participant's stress, the 8 sites for this study are localised. If you live near Des Moines, Fairfield, Albuquerque or any of the other 5 locations, then please consider that site to avoid long commutes."

Answered by AI

How many people are volunteer participants in this experiment?

"Indeed, a quick glance at the information provided on clinicaltrials.gov reveals that this trial is still looking for patients. The study was originally posted on 1/14/2022 and was last edited on 10/11/2022. A total of 126 patients are needed to be enrolled at 8 sites."

Answered by AI

ALXN2050 has not yet been cleared by the FDA, correct?

"Since this is a Phase 2 trial, meaning that while there is some safety data available, there is none regarding efficacy, we have given ALXN2050 a score of 2."

Answered by AI

Who else is applying?

What state do they live in?
California
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Clinical Trial Site
Recent research and studies
clinicaltrials.govStudy
Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
2022. "Study of ALXN2050 in Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05097989.
All > Lupus Nephritis > Iga Nephropathy
~34 spots leftby Jun 2026
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