RECRUITING

Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Conditions

Adolescent Lupus Nephritis Pediatric Lupus Nephritis Lupus nephritis calcineurin inhibitors voclosporin adolescents pediatrics

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to assess the efficacy and safety of voclosporin compared to placebo in achieving renal response following 24 weeks of therapy in adolescent and pediatric subjects with active lupus nephritis (LN).

Official Title

A Double-Blind, Placebo-Controlled, Dose Escalation Study to Assess the Efficacy, Safety and Pharmacokinetics of Voclosporin in Adolescent and Pediatric Subjects With Lupus Nephritis

Quick Facts

Study Start:2023-10-10

Study Completion:2028-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05288855

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:5 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria. * Subjects with kidney biopsy confirmed active lupus nephritis.	* 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.

Inclusion Criteria

Exclusion Criteria

* Previous diagnosis of systemic lupus erythematosus (SLE) as per the 2019 EULAR/ ACR classification criteria.
* Subjects with kidney biopsy confirmed active lupus nephritis.

* 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.

Contacts and Locations

Study Contact

Aurinia Clinical Trials Information

CONTACT

833-672-0028

clinicaltrials@auriniapharma.com

Study Locations (Sites)

Nemours Children's Hospital, Orlando

Orlando, Florida, 13535

United States

UNC-Chapel Hill

Chapel Hill, North Carolina, 27514

United States

Collaborators and Investigators

Sponsor: Aurinia Pharmaceuticals Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-10

Study Completion Date2028-06

Study Record Updates

Study Start Date2023-10-10

Study Completion Date2028-06

Terms related to this study

Keywords Provided by Researchers

Lupus nephritis
calcineurin inhibitors
voclosporin
adolescents
pediatrics

Additional Relevant MeSH Terms

Adolescent Lupus Nephritis
Pediatric Lupus Nephritis