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Lupus kidney drug tested in kids – but study stopped early

NCT ID NCT05962788

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at the long-term safety of the drug voclosporin in adolescents and children with lupus nephritis, a kidney disease caused by lupus. Participants took voclosporin capsules twice daily along with standard medications. The trial was terminated early and only enrolled 4 people, so the results are very limited.

What this could mean

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

Active substance
voclosporin
What this could lead to
If successful, this could show that voclosporin is safe and effective for long-term use in young people with lupus nephritis.
What could go wrong
The trial was terminated early and enrolled only 4 participants, so results are very limited. It is unclear if voclosporin offers benefits over standard care.

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

4 people

The number who actually took part.

Started

Mar 2024

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.

Inclusion Criteria: * Written informed consent from parent/guardian before any study-specific procedures are performed, if applicable per local regulations. * Age-appropriate assent or informed consent from subject before any study-specific procedures are performed. * Subjects who have completed 24 weeks of treatment with study drug (voclosporin/placebo) in the VOCAL study. Subjects who had a temporary interruption and were able to successfully re-start study drug will be allowed to enroll after Medical Monitor approval. * In the opinion of the Investigator subject requires continued immunosuppressive therapy. * Subject is willing to continue to take oral MMF for the duration of the study. Exclusion Criteria: * Currently taking or known need for any of the following medications during the study: * Cholestyramine or other drugs that may interfere with enterohepatic recirculation of MMF * Calcineurin inhibitors (CNIs) (e.g., cyclosporin and tacrolimus) * Strong CYP3A4/5 inhibitors and inducers (e.g., ketoconazole, rifampin, itraconazole, clarithromycin) * Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period. * A planned kidney transplant within study treatment period. * Subjects with any medical condition which in the Investigator's judgement may be associated with increased risk to the subject or may interfere with study assessments or outcomes

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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, 06720, Mexico

  • Siriraj Hospital

    Bangkok, 10700, Thailand

  • UNC-Chapel Hill

    Chapel Hill, North Carolina, 27514, United States

  • Yokohama City University Hospital

    Yokohama, Kanagawa, Japan

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