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GLP-1 receptor agonists as preventive treatment of diabetes after renal transplantation: randomized clinical trial. Study 1: Immediate Kidney Transplant Recipients
EU CTIS ID: 2023-506437-29-00
What this study is testing
To evaluate whether treatment with GLP-1 RA in a high-risk population in the immediate post-kidney transplant period prevents new-onset diabetes after transplantation at 3 months.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- De novo kidney transplant recipients older than 18 years,
- No history of diabetes (by clinical history, verbal information from patients directly or with pre-transplant HbA1c ≤ 6.5%),
- Who receive tacrolimus and prednisone as maintenance immunosuppressive treatment in the post-transplant period
- And with high risk of PTDM defined by two of these factors: -age > 50 years; -BMI ≥ 30 kg/m2; -first degree family history of diabetes; -hypertriglyceridemia (triglyceride level >2.82 mmol/L); -prediabetes (defined by any of: fasting glucose 100–126 mg/dL (5.6–6.9 mmol/L), or HbA1c 5.7–6.4%, or if available oral glucose tolerance test prior to inclusion with values of initial glucose <126 mg/dL (7 mmol/L) and 2h after the load between 140–200 mg/dL (7.8–11 mmol/L).
- Women of childbearing potential using effective contraception during study participation.
You likely can't join if
- Under 18 years of age,
- previously diagnosed diabetes,
- Hepatic failure
- history of pancreatitis (acute or chronic),
- multiple endocrine neoplasia syndrome type 2 (MEN 2),
- personal or family history history of medullary thyroid carcinoma (MTC)
See the full eligibility criteria
- De novo kidney transplant recipients older than 18 years,
- No history of diabetes (by clinical history, verbal information from patients directly or with pre-transplant HbA1c ≤ 6.5%),
- Who receive tacrolimus and prednisone as maintenance immunosuppressive treatment in the post-transplant period
- And with high risk of PTDM defined by two of these factors: -age > 50 years; -BMI ≥ 30 kg/m2; -first degree family history of diabetes; -hypertriglyceridemia (triglyceride level >2.82 mmol/L); -prediabetes (defined by any of: fasting glucose 100–126 mg/dL (5.6–6.9 mmol/L), or HbA1c 5.7–6.4%, or if available oral glucose tolerance test prior to inclusion with values of initial glucose <126 mg/dL (7 mmol/L) and 2h after the load between 140–200 mg/dL (7.8–11 mmol/L).
- Women of childbearing potential using effective contraception during study participation.
- Under 18 years of age,
- previously diagnosed diabetes,
- Hepatic failure
- history of pancreatitis (acute or chronic),
- multiple endocrine neoplasia syndrome type 2 (MEN 2),
- personal or family history history of medullary thyroid carcinoma (MTC)
- pregnant or lactating women
- moderate to severe pre-existing gastroparesis
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.