Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis

• Status: Terminated
• Trial end date: 2020-05-19
• Target enrollment: 0
• Participant gender: All

Summary

Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects with Focal Segmental Glomerulosclerosis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aurinia Pharmaceuticals Inc.
• Treatments: Cyclosporine

Criteria

Inclusion Criteria:

1. Primary FSGS diagnosed by renal biopsy.

2. Urine protein creatinine ratio (UPCR) ≥2.0 mg/mg, serum albumin ≤3.2 g/dL and can be immunosuppressant treatment-naïve, or receiving treatment with steroids.

3. Stable proteinuria, renal function, and BP.

Exclusion Criteria:

1. Clinical or histologic evidence of secondary FSGS.

2. Histologic evidence of collapsing variant FSGS.

3. eGFR as calculated by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation of ≤30 mL/minute/1.73 m2 at initial screening assessment or ≤45 mL/minute/1.73 m2 at last qualifying assessment.

4. Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.

5. Current or medical history of:

• Congenital or acquired immunodeficiency.

• In the opinion of the Investigator, clinically significant drug or alcohol abuse within 2 years prior to screening.

• Malignancy within 5 years of screening, with the exception of basal and squamous cell carcinomas treated by complete excision.

• Current or past lymphoproliferative disease or previous total lymphoid irradiation.

• Severe viral infection within 3 months of screening, or known HIV infection. Severe viral infection is defined as active disease requiring antiviral therapy.

• Active tuberculosis (TB) or known history of TB/evidence of old TB if not taking prophylaxis with isoniazid.