Last updated on July 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Focal glomerulosclerosis
  • Age: Between 18 - 75 Years
  • Gender: Male or Female

Inclusion Criteria:

  1. Primary FSGS diagnosed by renal biopsy within 6 months prior to end of screening.
  2. At initial screening assessment and at last qualifying assessment during screening period prior to baseline, FSGS subjects must have urine protein creatinine ratio (UPCR) 2.0 mg/mg, serum albumin 3.2 g/dL. Subjects can be treatment-nave or receiving steroid treatment (oral or IV) for FSGS. Subjects taking steroids must show signs of improvement in proteinuria, defined as at least a 20% improvement in UPCR from initiation of steroids to the last stability assessment prior to baseline. Subjects who have discontinued steroid treatment due to poor tolerability may be considered for the study.
  3. Stable proteinuria, renal function, and BP for at least 2 weeks prior to baseline, as assessed by the Investigator. Substantial changes in UPCR, estimated glomerular filtration rate (eGFR), and/or BP during the screening period may be due to treatments administered (e.g., ACEIs and ARBs); and, therefore, may interfere with study assessments or outcomes, or may place the subject at increased risk. These subjects must be discussed with the medical monitor prior to initiation of study treatment.

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 during screening period prior to baseline.
  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. Subjects with cervical dysplasia that is cervical intraepithelial neoplasia 1, but have been treated with conization or loop electrosurgical excision procedure and have had a normal repeat Papanicolaou test are allowed.
    • Current or past lymphoproliferative disease or previous total lymphoid irradiation.
    • Severe viral infection (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus) 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.

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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