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

Stopped early · Phase 2

Conditions studied: Focal Segmental Glomerulosclerosis

In brief

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

Key facts

Study ID

NCT03598036

Run by

Aurinia Pharmaceuticals Inc.

People needed

5

Starts

2018-06-21

Expected to finish

2020-05-19

Last updated by the study team

2021-09-16

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary FSGS diagnosed by renal biopsy.
• 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.
• Stable proteinuria, renal function, and BP.

You may not qualify if…

• Clinical or histologic evidence of secondary FSGS.
• Histologic evidence of collapsing variant FSGS.
• 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.
• Currently requiring renal dialysis (hemodialysis or peritoneal dialysis) or expected to require dialysis during the study period.
• 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.

Where it is running

• FSGS Investigative Center — Denver, Colorado, United States
• FSGS Investigative Center — Winter Park, Florida, United States
• FSGS Investigative Center — Lawrenceville, Georgia, United States
• FSGS Investigative Center — Chicago, Illinois, United States
• FSGS Investigative Center — Iowa City, Iowa, United States
• FSGS Investigative Center — Louisville, Kentucky, United States
• FSGS Investigative Center — Shreveport, Louisiana, United States
• FSGS Investigative Center — Detroit, Michigan, United States
• FSGS Investigative Center — Minneapolis, Minnesota, United States
• FSGS Investigative Centre — St Louis, Missouri, United States
• FSGS Investigative Center — Newark, New Jersey, United States
• FSGS Investigative Center — New York, New York, United States
• FSGS Investigative Center — Chapel Hill, North Carolina, United States
• FSGS Investigative Center — Charlotte, North Carolina, United States
• FSGS Investigative Center — Columbus, Ohio, United States
• FSGS Investigative Center — Bethlehem, Pennsylvania, United States
• FSGS Investigative Center — Dallas, Texas, United States
• FSGS Investigative Center — Dallas, Texas, United States
• FSGS Investigative Center — El Paso, Texas, United States
• FSGS Investigative Center — Houston, Texas, United States
• FSGS Investigative Site — Salt Lake City, Utah, United States
• FSGS Investigative Centre — Santiago de los Caballeros, Dominican Republic
• FSGS Investigative Center — Santo Domingo, Dominican Republic

Full record on ClinicalTrials.gov

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