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Safety, Pharmacokinetics, and Efficacy of AT 1501 in Patients Undergoing Kidney Transplant
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
Study details:
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation. Up to 24 de novo kidney transplant recipients will receive AT-1501 in combination with rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 18 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-02-18
Primary completion: 2025-09-01
Study completion finish: 2025-09-01
Study type
TREATMENT
Phase
PHASE1
PHASE2
Trial ID
NCT05027906
Intervention or treatment
DRUG: AT-1501
Conditions
- • Kidney Transplant
Find a site
Closest Location:
Royal Adelaide Hospital
Research sites nearby
Select from list below to view details:
Royal Adelaide Hospital
Adelaide, South Australia, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
EXPERIMENTAL: AT-1501 Single Arm
| DRUG: AT-1501
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Safety Incidences | Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAEs), and Adverse Events of Special Interest (AESIs) | 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) | 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) | Day 1 and at steady state Month 3 |
Pharmacokinetic- Cmax | Maximum observed plasma concentration (Cmax) | Day 1 and at steady state Month 3 |
Pharmacokinetic- Tmax | Time to reach maximum observed plasma concentration (Tmax) | Day 1 and at steady state Month 3 |
Pharmacokinetic- Ke | Terminal elimination rate constant (Ke) | Day 1 and at steady state Month 3 |
Pharmacokinetic- (t1/2) | Terminal phase half-life (t1/2) | Day 1 and at steady state Month 3 |
Pharmacokinetic- CL | Clearance (CL) | Day 1 and at steady state Month 3 |
Pharmacokinetic- (Vdss) | Volume of distribution at steady state (Vdss) | Day 1 and at steady state Month 3 |
Secondary outcome
Frequently Asked Questions
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