Lupus kidney drug tested in kids – but study stopped early
NCT ID NCT05962788
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
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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4 people
The number who actually took part.
- Started
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Mar 2024
- Finished
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Jul 2025
- Lead sponsor
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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
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Anyone
- Healthy volunteers
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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 Hide 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
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Centro de Especialidades Medicas del Sureste
Mérida, Yucatán, 97000, Mexico
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Clinica de la Costa S.A.S
Barranquilla, Atlántico, 76100, Colombia
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Hospital Infantil de México Federico Gómez
Mexico City, 06720, Mexico
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Siriraj Hospital
Bangkok, 10700, Thailand
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UNC-Chapel Hill
Chapel Hill, North Carolina, 27514, United States
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Yokohama City University Hospital
Yokohama, Kanagawa, Japan
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