Phase
Condition
Kidney Failure
Kidney Disease
Nephropathy
Treatment
VIR-2218
Clinical Study ID
Ages 18-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria for All Participants:
Participants must have stable renal function as defined by less than 20% change inestimated glomerular filtration rate (eGFR) between the first and second screeningsample with the first screening visit occurring within 28 days prior to dosing onDay 1 and the second screening visit occurring no more than 14 days apart, but atleast 72 hours apart from the first.
Body mass index (BMI) within the range 18.5 to 40.0 kg/m^2 at screening.
Female and Male participants must consent to follow contraception requirements
Capability of giving signed informed consent form
Inclusion Criteria: Additional Criteria Specific to Healthy Participants:
Must be in the opinion of the investigator, be in good health based upon medicalhistory, vital signs, physical examination, and screening laboratory evaluations
Must have normal renal function as defined by eGFR ≥ 90 mL/min/1.73m^2 based on theModification of Diet in Renal Disease (MDRD) equation determined from the mean oftwo measurements of serum creatinine at screening.
Inclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
Participants must, in the opinion of the investigator, be sufficiently healthy forstudy participation based on medical history, physical examination, vital signs, andscreening laboratory evaluations
Participants with RI must have chronic moderate or severe RI and be clinicallystable per investigator assessment for at least 3 months prior to screening
Moderate RI as defined by eGFR level 30-59 mL/min/1.73m^2 based on the MDRDequation, or
Severe RI as defined by eGFR level 15-29mL/min/1.73m^2 based on the MDRD equation
Exclusion
Exclusion Criteria: Criteria for All Participants
Any clinically significant medical condition or psychiatric condition that mayinterfere with study intervention
Participants with uncontrolled hypertension, asthma, and/or diabetes (Type I or II).
Participants with diabetes
Participants with any active malignancy
Participants with vasculitis or conditions associated with vasculitis.
Participants who have undergone major surgery within 12 months of screening
Participants with unstable cardiac functions, abnormality, or clinically significantheart failure
Participants with infection of HIV, HAV, HBV, HCV, HDV, or HEV
Participants with signs of active infection
History of bone marrow or solid organ transplantation
Participants with end-stage renal disease or nephrotic syndrome as defined by:participants requiring hemodialysis or peritoneal dialysis, participants who haveundergone or are listed for transplant, or participants who have chronic kidneydisease with nephrotic syndrome
Participants with active nephritis
Participants with clinically significant liver disease
History of drug or alcohol abuse
Unwillingness or inability to follow procedures outlined in protocol
Exclusion Criteria: Additional Criteria Specific to Healthy Participants
- Use of any prescription medications or over-the-counter medications (with theexception of vitamins and/or hormonal contraceptive medications) including herbalproducts within 30 days prior to D1 of study participation
Exclusion Criteria: Additional Criteria Specific to Participants with Renal Impairment
- Not on stable dose and regimen of any medication(s) (prescription orover-the-counter) that the participants is taking regularly (eg, medications forchronic conditions such as hypertension, high cholesterol, or depression must not bechanged in dose or type for at least 2 weeks prior to study drug administration).Use of other prescription medications or over-the-counter medications that are notfor chronic conditions (with the exception of vitamins and/or hormonal contraceptivemedications) including herbal products within 30 days prior to D1 of studyparticipation
Study Design
Study Description
Connect with a study center
Inland Empire Clinical Trials
Rialto, California 92377
United StatesSite Not Available
Floridian Clinical Research
Miami Lakes, Florida 33016
United StatesSite Not Available
Orlando Clinical Research Center
Orlando, Florida 32809
United StatesSite Not Available

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