What side effects are associated with this type of intervention?

Common treatments for Lupus Nephritis include immunosuppressive therapies like glucocorticoids and drugs such as hydroxychloroquine. Glucocorticoids can lead to serious adverse events, including increased risk of infections, hypertension, diabetes, and osteoporosis, especially at high doses. Hydroxychloroquine is generally well-tolerated but can cause gastrointestinal upset, skin rashes, and, rarely, retinal toxicity. Investigational agents, such as complement inhibitors and immunomodulators, are being studied for their efficacy and safety, with potential side effects including increased risk of infections and other immune-related issues.

What prior FDA approvals exist?

The FDA has approved several treatments for Lupus Nephritis, primarily focusing on immunosuppressive and immunomodulatory therapies. Notable drugs include mycophenolate mofetil (CellCept) and cyclophosphamide, which are often used in combination with corticosteroids. More recently, belimumab (Benlysta), a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS), was approved for LN. Voclosporin (Lupkynis), a calcineurin inhibitor, has also been approved for use in combination with mycophenolate mofetil and corticosteroids. These treatments aim to reduce immune system activity to prevent kidney damage.

What other types of research exist?

Promising novel alternatives to ALXN2050 for Lupus Nephritis patients include voclosporin, a calcineurin inhibitor that has shown efficacy in reducing proteinuria and improving renal function, and belimumab, a monoclonal antibody that inhibits B-lymphocyte stimulator (BLyS) and has been approved for use in LN. Additionally, obinutuzumab, an anti-CD20 monoclonal antibody, is being investigated in clinical trials and has shown potential benefits in LN treatment.

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ALXN2050 for Kidney Disease

Phase 2

Waitlist Available

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 baseline, week 26 and week 50

Summary

This trial tests a new medication, ALXN2050, in adults with serious kidney diseases (LN or IgAN). The goal is to improve kidney function and manage symptoms.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 26 and week 50

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 26 and week 50

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 26 and week 50 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 26

Secondary study objectives

Both Cohorts: Participants Achieving > 30% And > 50% Reduction In Proteinuria At Week 26 And Week 50 Compared To Baseline

Both Cohorts: Percentage Change In Proteinuria From Baseline To Week 50

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

Do I qualify?Apply below to find out

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.