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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03598036
• Date of registration: 14/06/2018
• Prospective Registration: Yes
• Primary sponsor: Aurinia Pharmaceuticals Inc.
• Public title: Dose-Exploration Evaluating the Efficacy and Safety of Voclosporin in Subjects With Focal Segmental Glomerulosclerosis AURONA™
• Scientific title: An Open-Label Dose-Exploration Cohort Study Evaluating the Efficacy and Safety of Voclosporin in Achieving Complete or Partial Remission of Proteinuria in Subjects With Focal Segmental Glomerulosclerosis
• Date of first enrolment: June 21, 2018
• Target sample size: 5
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03598036
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Dominican Republic, United States

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Focal Segmental Glomerulosclerosis

Intervention(s)

Drug: Voclosporin

Primary Outcome(s)

Proportion of subjects with remission of proteinuria [Time Frame: 24 weeks]

Secondary Outcome(s)

Duration of reduced UPCR [Time Frame: Up to 26 weeks]

Time to first occurrence of 50% reduction in UPCR from baseline [Time Frame: Up to 26 weeks]

Change in UPCR [Time Frame: Week 24 and 26]

Proportion of subjects with complete remission of proteinuria [Time Frame: Weeks 8, 12, and 24]

Change from baseline in UPCR [Time Frame: Week, 2,4,8,12,18,24]

Time to first occurrence of partial remission of proteinuria [Time Frame: Up to 26 weeks]

Change in eGFR [Time Frame: Week 24 and 26]

Proportion of subjects with a confirmed decrease from baseline in eGFR [Time Frame: Week, 2,4,8,12,18,24]

Proportion of subjects with partial remission of proteinuria [Time Frame: Weeks 8, 12, and 24]

Time to first occurrence of complete or partial remission of proteinuria [Time Frame: Up to 26 weeks]

Change from baseline in serum creatinine, serum albumin, and eGFR [Time Frame: Week, 2,4,8,12,18,24]

Proportion of subjects with a confirmed increase in eGFR [Time Frame: Final Visit (week 24) to second Safety Follow-up visit (Visit 10)]

Renal biopsy [Time Frame: 24 weeks]

Proportion of subjects with reduction of proteinuria [Time Frame: Weeks 8, 12, and 24]

Quality of life assessments [Time Frame: Week 24]

Time to first occurrence of complete remission of proteinuria [Time Frame: Up to 26 weeks]

Proportion of subjects with complete remission or partial remission of proteinuria [Time Frame: Weeks 8 and 12]

Safety and tolerability (treatment-emergent adverse events) [Time Frame: 24 weeks]

Secondary ID(s)

AUR-VCS-2017-03

Source(s) of Monetary Support

Please refer to primary and secondary sponsors