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Lupus kidney drug for teens shows promise, but trial cut short

NCT ID NCT05288855

Disease control Sponsor: Aurinia 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 voclosporin in teenagers with lupus nephritis, a kidney disease caused by lupus. The goal was to see if it could improve kidney function better than a placebo. Only 9 teens took part before the study was stopped early, so we don't have clear answers yet. The results may still help researchers design better future studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Voclosporin (a drug that calms the immune system)
What this could lead to
If it works, this could point toward a treatment option for teenagers with lupus kidney disease.
What could go wrong
The trial was terminated early with only 9 participants, so results are very limited. Voclosporin may not work better than standard care and can have side effects like kidney problems or infections.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

9 people

The number who actually took part.

Started

Oct 2023

Finished

Jul 2025

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

5 to 17 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: * Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria. * Subjects with kidney biopsy confirmed active lupus nephritis. Exclusion Criteria: * Estimated glomerular filtration rate (eGFR) \<60 mL/minute/1.73 m2 at screening. * Current or medical history of: * Congenital or acquired immunodeficiency. * Clinically significant drug or alcohol abuse prior to screening. * Malignant neoplasm. * Lymphoproliferative disease or previous total lymphoid irradiation. * Known severe viral infections within 3 months of screening; or known human immunodeficiency virus infection, or hepatitis B or C virus infection at any time prior to screening. * Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid. * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. * Other known clinically significant active medical conditions, for which the condition or the treatment of the condition may affect the study assessments or outcomes. * Currently taking or known need for any of the following medications: * Immunosuppression biologic agents within 12 weeks prior to randomization, cyclophosphamide, calcineurin inhibitors (CNIs) and live attenuated vaccines, initiation or dose change of ACE inhibitors/ARBs within 4 weeks prior to randomization, IV corticosteroids and IV immunoglobulin within 2 weeks prior to screening, strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization.

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Conditions

The condition(s) this trial relates to.

lupus nephritis

As listed by the trial registrant

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

Adolescent lupus nephritis Pediatric lupus nephritis

Contacts and locations

Locations

  • Centro de Especialidades Medicas del Sureste

    Mérida, Yucatán, 97000, Mexico

  • Clinica de la Costa S.A.S

    Barranquilla, Atlántico, 76100, Colombia

  • Hospital Infantil de México Federico Gómez

    Mexico City, Mexico

  • Nemours Children's Hospital, Orlando

    Orlando, Florida, 13535, United States

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • Yokohama City University Hospital

    Yokohama, Kanagawa, Japan

More trials for these conditions

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