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Kidney disease drug trial halted midway: what happened?

NCT ID NCT05097989

Disease control Sponsor: Alexion Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a drug called ALXN2050 in people with kidney inflammation caused by lupus (lupus nephritis) or IgA nephropathy. The goal was to see if it could reduce protein in the urine, a sign of kidney damage. About 100 adults were planned to take the drug or a placebo alongside their usual care. The trial was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

100 people

The number who actually took part.

Started

Jan 2022

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: Both Cohorts * Participants on sodium-glucose cotransporter-2 (SGLT 2) inhibitors (eg, empagliflozin) must be on a stable dose for ≥ 3 months with no planned change in dose during the Blinded Treatment Periods (through Week 50). 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. Participants with de novo or relapsing disease may be eligible. * Clinically active LN at Screening requiring/receiving immunosuppression induction treatment in the opinion of the Investigator. * Proteinuria with UPCR ≥ 1 g/g based on one 24 hour urine collection during the Screening Period. IgAN Cohort * Established diagnosis of primary IgAN based on kidney biopsy obtained any time prior to or during the Screening Period. * Mean proteinuria ≥ 1 g/day on 2 complete and valid 24 hour urine collections during the Screening Period. * For participants with a kidney biopsy performed \> 1 year prior to Screening that was used for eligibility: Presence of hematuria as defined by a positive result for blood on urine dipstick or ≥ 10 red blood cells (RBCs)/high power field (hpf) microscopy on urine sediment (documented by the local laboratory) during Screening Period. Presence of hematuria documented by the central laboratory may also be acceptable. * Compliance with stable and optimal dose of RAS inhibitor treatment including maximum allowed or tolerated ACE inhibitor and/or ARB dose for ≥ 3 months prior to Screening with no expected change in dose during the Blinded Treatment Periods (through Week 50) (participants with established intolerance to RAS inhibitors may be included). * Controlled and stable blood pressure (defined as \< 140/90 millimeters of mercury \[mmHg\]) over the past 3 months prior to randomization. Key Exclusion Criteria: Both Cohorts * eGFR ≤ 30 milliliters/minute/1.73 squared meters during Screening calculated by Chronic Kidney Disease Epidemiology Collaboration. * For participants with eGFR \< 45 mL/min/1.73 m2 at Screening, presence of any of the following in glomeruli on most recent kidney biopsy prior to or during the Screening Period: 1. ≥ 50% interstitial fibrosis and tubular atrophy 2. ≥ 50% glomerular sclerosis 3. ≥ 50% active crescent formation * Concomitant significant renal disease other than LN or IgAN on the most recent biopsy prior to or during the Screening Period. * History of solid organ or bone marrow transplant, or planned transplant during the Blinded Extended Treatment Period (50 weeks). * Splenectomy or functional asplenia. * Known or suspected complement deficiency, unless attributable to underlying disease (that is, LN and IgAN). * Bone marrow insufficiency with absolute neutrophil count \< 1.3 × 10\^3/microliter; thrombocytopenia (platelet count \< 50,000/cubic millimeter). LN Cohort * Participants who have initiated any of the following treatments for the current active LN flare: 1. Cyclophosphamide ≤ 6 months prior to Screening 2. CNIs ≤ 1 months prior to Screening 3. A cumulative dose of intravenous (IV) methylprednisolone \> 3 g 4. Mycophenolate mofetil \> 2 g/day (or equivalent) for ≥ 8 consecutive weeks prior to Screening 5. Prednisone or prednisone equivalent ≥ 0.5 mg/kg/day for ≥ 8 consecutive weeks prior to Screening * Uncontrolled hypertension (systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 110 mmHg) on 2 or more measurements during the Screening Period. * Prior history or clinically active SLE-related cerebritis, seizures, stroke, or stroke syndrome requiring treatment or clinically active pericarditis * Inability to take or tolerate the standard of care background therapies IgAN Cohort * Diagnosis of rapid progressive glomerulonephritis as measured by eGFR loss ≥ 30% over a period of 3 months prior to or during the Screening Period. * Secondary etiologies of IgAN. * Prednisone or prednisone equivalent \> 20 mg/day for \> 14 consecutive days or any other systemic immunosuppression for the treatment of IgAN ≤ 6 months prior to Screening * Blood pressure of ≥ 140/90 mmHg during the Screening Period confirmed on 2 measures \> 30 minutes apart.

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Conditions

The condition(s) this trial relates to.

IgA glomerulonephritis IgA nephropathy, susceptibility to, 1 lobular neoplasia lupus nephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

IGAN Immunoglobulin A nephropathy LN Lupus nephritis

Contacts and locations

Locations

  • Research Site

    Huntsville, Alabama, 35805, United States

  • Research Site

    Loma Linda, California, 92350, United States

  • Research Site

    Northridge, California, 91324, United States

  • Research Site

    Gainesville, Florida, 32603, United States

  • Research Site

    Nampa, Idaho, 83687, United States

  • Research Site

    Des Moines, Iowa, 50309, United States

  • Research Site

    Kansas City, Missouri, 64111, United States

  • Research Site

    Albuquerque, New Mexico, 87106, United States

  • Research Site

    New York, New York, 10016, United States

  • Research Site

    Houston, Texas, 77054, United States

  • Research Site

    Ciudad de Buenos Aires, C1015ABO, Argentina

  • Research Site

    Córdoba, 5000, Argentina

  • Research Site

    La Plata, B1902COS, Argentina

  • Research Site

    Rosario, S2000DEJ, Argentina

  • Research Site

    Clayton, 3168, Australia

  • Research Site

    Liverpool, 2170, Australia

  • Research Site

    Nedlands, 6009, Australia

  • Research Site

    Westmead, 2145, Australia

  • Research Site

    Belo Horizonte, 30150-221, Brazil

  • Research Site

    Curitiba, 80030-110, Brazil

  • Research Site

    Juiz de Fora, 36010-570, Brazil

  • Research Site

    Porto Alegre, 90035-003, Brazil

  • Research Site

    Porto Alegre, 90480-000, Brazil

  • Research Site

    Salvador, 40150-150, Brazil

  • Research Site

    Guangzhou, 510080, China

  • Research Site

    McKinney, 75069, China

  • Research Site

    Shanghai, 200040, China

  • Research Site

    Berlin, 10117, Germany

  • Research Site

    Essen, 45122, Germany

  • Research Site

    Mainz A. Rhein, 55131, Germany

  • Research Site

    Mannheim, 68135, Germany

  • Research Site

    Marburg, 30625, Germany

  • Research Site

    München, 81377, DE, Germany

  • Research Site

    Ashkelon, 78306, Israel

  • Research Site

    Haifa, 3109601, Israel

  • Research Site

    Petah Tikva, 4941492, Israel

  • Research Site

    Ramat Gan, 52621, Israel

  • Research Site

    Bari, 70124, Italy

  • Research Site

    Brescia, 25123, Italy

  • Research Site

    Milan, 20132, Italy

  • Research Site

    Naples, 80131, Italy

  • Research Site

    Torino, 10154, Italy

  • Research Site

    Guadalajara, 44140, Mexico

  • Research Site

    México, 11570, Mexico

  • Research Site

    Torreón, 27000, Mexico

  • Research Site

    Niš, 18000, Serbia

  • Research Site

    Novi Sad, 21000, Serbia

  • Research Site

    Busan, 49241, South Korea

  • Research Site

    Goyang-si, 10380, South Korea

  • Research Site

    Seoul, 03080, South Korea

  • Research Site

    Barcelona, 08025, Spain

  • Research Site

    Barcelona, 8003, Spain

  • Research Site

    Córdoba, 14004, Spain

  • Research Site

    Girona, 17007, Spain

  • Research Site

    L'Hospitalet de Llobregat, 08907, Spain

  • Research Site

    Palma de Mallorca, 07120, Spain

  • Research Site

    Seville, 41013, Spain

  • Research Site

    Valencia, 46026, Spain

  • Research Site

    Kaohsiung City, 833, Taiwan

  • Research Site

    New Taipei City, 220, Taiwan

  • Research Site

    New Taipei City, 23561, Taiwan

  • Research Site

    Taichung, 40705, Taiwan

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Istanbul, 34093, Turkey (Türkiye)

  • Research Site

    Bristol, BS105NB, United Kingdom

  • Research Site

    Cambridge, CB2 0QQ, United Kingdom

  • Research Site

    Doncaster, DN2 5LT, United Kingdom

  • Research Site

    Leicester, LE5 4PW, United Kingdom

  • Research Site

    London, E1 1BB, United Kingdom

  • Research Site

    London, SE5 9RS, United Kingdom

  • Research Site

    Manchester, M13 9WL, United Kingdom

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