This study is testing a new medicine called frexalimab in adults receiving their first kidney transplant. Researchers want to find out whether frexalimab is as safe and effective as the current standard treatment, tacrolimus, at preventing rejection of a transplanted kidney.
After a kidney transplant, the body's immune system can attack the new kidney. This is called rejection. Medicines are used to reduce this risk and help the transplanted kidney continue working well.
This study compares a new investigational medicine called frexalimab with tacrolimus, a commonly used anti-rejection medicine. Researchers want to learn whether frexalimab can safely prevent rejection while maintaining good kidney function after transplant.
Participants will be randomly assigned to receive either frexalimab or tacrolimus, along with other standard medicines used after kidney transplantation. The study will monitor participants' health, kidney function, quality of life and any side effects over a period of up to five years.
Anticipated enrolment closing date: August 2028
Who can take part
You may be eligible to participate if you:
- are aged 18 years or older.
- have kidney disease and are waiting for your first kidney transplant.
- are about to receive your first kidney transplant.
- are willing to attend study visits and follow study requirements.
- meet all study eligibility criteria determined by the study doctor.
What's involved for you
Participants who join the study will:
- be randomly assigned to receive either frexalimab or tacrolimus post kidney transplant.
- receive standard medicines used to help prevent transplant rejection.
- attend regular study visits over up to 5 years (approximately 38 visits in total).
- have regular health checks, including physical examinations and vital signs.
- provide blood and urine samples.
- complete questionnaires about their health and quality of life.
- have regular tests to check how well their transplanted kidney is working.
- have a kidney biopsy approximately 12 months after transplant and additional biopsies if clinically required.
Ethics
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by an Australian registered and certified HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2025). This statement protects the interests of people who agree to participate in human research studies.