A study to look at the effect and how safe the drug, Voclosporin, is in adolescents with a type of kidney disease called Lupus Nephritis

Phase 1

• Conditions: upus Nephritis; MedDRA version: 21.1Level: PTClassification code 10025140Term: Lupus nephritisSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Body processes [G] - Immune system processes [G12]

• Registration Number: EUCTR2020-005807-37-ES
• Lead Sponsor: Aurinia Pharmaceuticals Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-01-18
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Male or female subjects 12 to <18 years of age at the time of screening

2. Previous diagnosis of SLE according to the 2019 EULAR/ACR classification criteria.

3. Subjects with kidney biopsy result, with evidence of active nephritis

Refer to protocol for full list of inclusion criteria
Are the trial subjects under 18? yes
Number of subjects for this age range: 40
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Estimated glomerular filtration rate of <60 mL/min/1.73 m2 at screening confirmed before randomization

2. Use of immunosuppression biologic agents within 12 weeks prior to randomization

3. Use of cyclophosphamide, cholestyramine, calcineurin inhibitors, live attenuated vaccines and initiation or dose changes in ARBs and ACEi within 4 weeks prior to randomisation

4. Use of Strong CYP3A4/5 inhibitors and inducers within 2 weeks prior to randomization

5. Currently requiring renal dialysis or expected to require dialysis during the study period

6. A previous kidney transplant or planned transplant within study treatment period.

7. Any medical condition which, in the Investigator’s judgment, may be associated with increased risk to the subject or may interfere with study assessments or outcomes.

8. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions

Refer to protocol for full list of exclusion criteria

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified