This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 48 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Investigative Arm
University of Cincinnati
Cincinnati, Ohio, United States
RECRUITINGRoyal Prince Alfred Hospital
Camperdown, New South Wales, Australia
RECRUITINGSafety Incidences
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs)
Time frame: Through study completion, an average up to 20 months
Pharmacokinetic- PK profile
PK profile of the first dose of AT 1501 and at steady state Area under the plasma concentration-time curve from time 0 to the last quantifiable concentration (Ct), calculated using noncompartmental analysis (AUC0-t)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- Area under the plasma concentration
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity, calculated using noncompartmental analysis (AUC0-inf)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- Cmax
Maximum observed plasma concentration (Cmax)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- Tmax
Time to reach maximum observed plasma concentration (Tmax)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- Ke
Terminal elimination rate constant (Ke)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- (t1/2)
Terminal phase half-life (t1/2)
Time frame: Day 1 and at steady state Month 3
Pharmacokinetic- CL
Clearance (CL)
Time frame: Day 1 and at steady state Month 3
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Royal Adelaide Hospital
Adelaide, South Australia, Australia
RECRUITINGFundação Oswaldo Ramos - Hospital do Rim
São Paulo, Brazil
RECRUITINGProvidence Health Care - St. Paul's Hospital
Vancouver, British Columbia, Canada
RECRUITINGVancouver General Hospital
Vancouver, British Columbia, Canada
RECRUITINGMcGill University Health Care Centre
Montreal, Quebec, Canada
RECRUITINGLiverpool University Hospitals NHS Foundation Trust - Royal Liverpool University Hospital
Liverpool, United Kingdom
RECRUITINGOxford University Hospitals NHS Foundation Trust - John Radcliffe Hospital
Oxford, United Kingdom
RECRUITINGPharmacokinetic- (Vdss)
Volume of distribution at steady state (Vdss)
Time frame: Day 1 and at steady state Month 3