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Safety and Efficacy of Tegoprubart in Patients Undergoing Kidney Transplantation
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
Study details:
This study is a randomized, multicenter, open-label, active control study to evaluate the safety and efficacy of AT-1501 compared with tacrolimus in the prevention of rejection in patients undergoing kidney transplantation. Up to 120 de novo kidney transplant recipients will receive rATG induction with corticosteroids (CS), and mycophenolate as maintenance therapy, and will be randomized 1:1 to receive either AT-1501 or tacrolimus.
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: 2023-08-30
Primary completion: 2025-03-01
Study completion finish: 2025-03-01
Study type
TREATMENT
Phase
PHASE2
Trial ID
NCT05983770
Intervention or treatment
DRUG: AT-1501
DRUG: Tacrolimus
Conditions
- • Kidney Transplant Rejection
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
Fiona Stanley Hospital
Perth, Western 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: Investigative
| DRUG: AT-1501
|
ACTIVE_COMPARATOR: Comparator
| DRUG: Tacrolimus
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
eGFR at 12 months | Estimated Glomerular Filtration Rate (eGFR) at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12) |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
NODAT at 12 months post-transplant | The proportion of new onset diabetes after transplant (NODAT) at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12 |
The proportion of patient and graft survival at 12 months post-transplant | Patient and graft survival are defined as either A) Death, B) re-transplantation or C) Requirement for regular dialysis | Assessed from date of transplant through Day 364 (Month 12) |
BPAR-free patient and graft survival at 12 months post-transplant | Assessed from date of transplant through Day 364 (Month 12) | The proportion of BPAR-free patient and graft survival at 12 months post-transplant |
BPAR at 12 months | The proportion of BPAR at 12 months | Assessed from date of transplant through Day 364 (Month 12) |
Frequently Asked Questions
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