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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

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Lupus Nephritis (LN) include immunosuppressive agents like cyclophosphamide and mycophenolate mofetil, corticosteroids, and emerging therapies such as complement inhibitors. Immunosuppressive agents work by reducing the activity of the immune system, thereby decreasing the inflammation and autoantibody production that damage the kidneys. Corticosteroids, such as prednisone, provide rapid anti-inflammatory effects to control acute flares. Complement inhibitors, which are being studied in trials like ALXN2050, aim to block the complement system—a part of the immune system that contributes to inflammation and tissue damage in LN. These treatments are crucial for LN patients as they help to preserve kidney function, reduce symptoms, and prevent long-term complications.

Find a Location

Who is running the clinical trial?

Alexion Pharmaceuticals, Inc.Lead Sponsor
255 Previous Clinical Trials
41,221 Total Patients Enrolled
1 Trials studying Lupus Nephritis
120 Patients Enrolled for Lupus Nephritis
AlexionLead Sponsor
246 Previous Clinical Trials
39,255 Total Patients Enrolled
1 Trials studying Lupus Nephritis
120 Patients Enrolled for Lupus Nephritis
Alexion PharmaceuticalsLead Sponsor
230 Previous Clinical Trials
37,351 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
~30 spots leftby Jun 2026