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

Phase 2TerminatedNCT03598036

Aurinia Pharmaceuticals Inc.5 enrolled

Overview

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

The aim of the current study to assess the efficacy of voclosporin in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS). As well as to assess the safety and tolerability of voclosporin over 24 weeks in subjects with FSGS.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Focal Segmental Glomerulosclerosis

Interventions

VoclosporinDRUG

Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID). The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (23)

FSGS Investigative Center

Denver, Colorado, United States

Outcomes

Primary Outcomes

Proportion of Subjects With Remission of Proteinuria

Complete remission OR Partial remission

Time frame: 24 weeks

Secondary Outcomes

Proportion of Subjects With Complete Remission or Partial Remission of Proteinuria

Complete remission or partial remission of proteinuria

Time frame: Weeks 8 and 12

Proportion of Subjects With Complete Remission of Proteinuria

Complete remission of proteinuria

Time frame: Weeks 8, 12, and 24

Proportion of Subjects With Reduction of Proteinuria

Reduction of proteinuria

Time frame: Weeks 8, 12, and 24

Proportion of Subjects With Partial Remission of Proteinuria

Partial remission of proteinuria

Time frame: Weeks 8, 12, and 24

Time to First Occurrence of Complete or Partial Remission of Proteinuria

Complete OR partial remission of proteinuria

Time frame: Up to 26 weeks

Time to First Occurrence of Complete Remission of Proteinuria

Complete remission of proteinuria

Time frame: Up to 26 weeks

Time to First Occurrence of Partial Remission of Proteinuria

Partial remission of proteinuria

Time frame: Up to 26 weeks

Data from ClinicalTrials.gov

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