AURONA - 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

  • STATUS
    Recruiting
Updated on 23 November 2020

Summary

Open-label, 24-week, multicenter, exploratory cohort study of VCS

- To assess the efficacy of voclosporin (VCS) in achieving complete or partial remission of proteinuria after 24 weeks of therapy in subjects with focal segmental glomerulosclerosis (FSGS).

- To assess the safety and tolerability of VCS over 24 weeks in subjects with FSGS.

 

Description

OPEN label . Lab tests that are not usually done at the medical office. possible extension of the study.

Details
Condition Kidney Disease
Clinical Study IdentifierTX227891
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 18 yrs and 75 yrs?
Gender: Male or Female
Do you have Kidney Disease?
Written informed consent before any study-specific procedures are
performed
Male or female subjects with a minimum age of 18 years (or legal age of
consent if >18 years) to 75 years of age, inclusive, at the time of consent
Primary FSGS diagnosed by renal biopsy within 6 months prior to the
screening visit
At initial screening assessment and at last qualifying assessment
during screening period prior to baseline, FSGS subjects must have urine
protein creatinine ratio (UPCR) ≥3.0 mg/mg, serum albumin <3.2 g/dL AND must
be treatment-naive, defined as subjects who have not received systemic
steroids, cytotoxic or other systemic immunosuppressant treatment, and are not
expected to require treatment with these medications during the study
All subjects should be treated with angiotensin converting enzyme
inhibitors (ACEIs) and/or angiotensin receptor blockers (ARBs) unless they
have documented intolerance or contraindication to these medications. Doses of
these agents must be stable for at least 2 weeks prior to baseline, with blood
pressure (BP) ≤150/90 mmHg at the baseline visit (Visit 2)
a) Subjects with nephrotic edema may be treated with diuretics during the
screening period. Volume status should be optimized based on the clinical
judgment of the Investigator and the doses of diuretics must be stable for at
least 2 weeks prior to baseline
b) At the discretion of the Investigator, subjects with hyperlipidemia may be
treated with lipid-lowering agents (e.g., statins) in accordance with standard
clinical practice. Doses must be stable for at least 2 weeks prior to
baseline
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
Women of childbearing potential must have a negative serum pregnancy
test prior to dispensing study treatment. Two effective forms of contraception
must be used simultaneously unless abstinence is the chosen method. Subjects
must use effective contraception during the study

Exclusion Criteria

Subjects unable or unwilling to give written informed consent and/or to
comply with study procedures
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 during
screening period prior to baseline
Currently taking or expected to require any of the prohibited
medications listed in the protocol at screening or during the study. This
includes prohibited medications prior to screening as specified in the
protocol
Currently requiring renal dialysis (hemodialysis or peritoneal
dialysis) or expected to require dialysis during the study period
A previous renal transplant or planned renal transplant during the
study
Body mass index >40 kg/m2
Family history of nephrotic syndrome
Any known hypersensitivity or contraindication to cyclosporine, or
components of any cyclosporine drug product
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
Other clinically significant active medical conditions, such as
\- Severe cardiovascular disease including congestive heart failure, history
of cardiac dysrhythmia or congenital long QT syndrome. Subjects with QT
interval duration corrected for heart rate using method of Fridericia
exceeding 480 msec in the presence of a normal QRS interval (<110 msec) at
time of screening are excluded
\- Liver dysfunction: aspartate aminotransferase, alanine aminotransferase, or
bilirubin ≥2.5 times the upper limit of normal at last qualifying assessment
during screening period prior to baseline
\- Chronic obstructive pulmonary disease or asthma requiring oral steroids
\- Bone marrow insufficiency: white blood cell count <2,500/mm3, absolute
neutrophil count <1.3 × 103 /μL, and/or thrombocytopenia (platelet count
<50,000/mm3 at screening or at last qualifying assessment during screening
period prior to baseline
\- Current infection requiring intravenous antibiotics
Any overlapping autoimmune condition for which the condition or the
treatment of the condition may affect the study assessments or outcomes (e.g
any condition for which additional immunosuppression, including systemic
corticosteroids, and/or cytotoxic therapy is indicated). Overlapping
conditions for which the condition or treatment is not expected to affect
assessments or outcomes are not excluded
No vaccines using live organisms, virus or bacterial, are allowed
during screening and while taking the study treatment
Other major physical or psychiatric illness or major traumatic injury
within 6 months prior to screening that may affect study conduct or interfere
with study assessments or outcome
Any other medical condition which, in the Investigator's judgment, may
be associated with increased risk to the subject or may interfere with study
assessments or outcomes
Subjects who are pregnant, breast feeding or, if of childbearing
potential, not using adequate contraceptive precautions
Participation in another interventional clinical study within 4 weeks
prior to screening and/or receipt of investigational drugs within 4 weeks or 5
half-lives of the drug (whichever is longer) prior to screening
Subjects treated in a previous VCS clinical study
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