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Safety and efficacy of oral semaglutide in hyperglycaemic patients after renal transplantation
EU CTIS ID: 2023-504159-29-01
What this study is testing
The primary objective is to establish whether oral semaglutide (Rybelsus) compared with placebo, both as add-on to standard-of-care, is non-inferior in regulating plasma glucose in patients with hyperglycaemia after renal transplantation.
- Therapeutic exploratory (Phase II)
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
- Written informed consent obtained before any trial-related procedures are performed
- Male or female; age: 18–80 years
- Diagnosis of post-transplant hyperglycaemia 10 to 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L, or Pre-transplant type 2 diabetes: Receiving glucose-lowering treatment prior to kidney transplantation.
- An eGFR > 15 ml/min/1.73 m2 10 to 40 days after renal transplantation
- Subject must be willing and able to comply with trial protocol
You likely can't join if
- Type 1 diabetes
- Dialysis
- High risk immunological transplantation (not including ABO-incompatible or re-transplantation)
- Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone)
- Chronic pancreatitis/previous acute pancreatitis
- Known or suspected hypersensitivity to trial or related products
See the full eligibility criteria
- Written informed consent obtained before any trial-related procedures are performed
- Male or female; age: 18–80 years
- Diagnosis of post-transplant hyperglycaemia 10 to 40 days after transplantation: Fasting plasma glucose ≥ 7.0 mmol/L or an oral glucose tolerance test with at plasma glucose ≥ 11.1 mmol/L, or Pre-transplant type 2 diabetes: Receiving glucose-lowering treatment prior to kidney transplantation.
- An eGFR > 15 ml/min/1.73 m2 10 to 40 days after renal transplantation
- Subject must be willing and able to comply with trial protocol
- Type 1 diabetes
- Dialysis
- High risk immunological transplantation (not including ABO-incompatible or re-transplantation)
- Early graft rejection (all rejections verified by biopsy, except borderline rejections. Study initiations can begin 5 days after last dose of rejection treatment with methylprednisolone)
- Chronic pancreatitis/previous acute pancreatitis
- Known or suspected hypersensitivity to trial or related products
- Use of DPP-4 inhibitors within five days prior to screening
- Use of GLP-1RA within 10 days prior to screening
- Inflammatory bowel disease
- Previous bowel resection
- Cardiac disease defined as decompensated heart failure (New York Heart Association class III-IV) and/or diagnosis of unstable angina pectoris and/or myocardial infarction within the last six months
- Any acute condition or exacerbation of chronic condition that would in the investigator’s opinion interfere with the initial trial visit schedule and procedures.
- Females of childbearing potential who are pregnant, breast-feeding, intend to become pregnant, or are not using adequate contraceptive methods
- Malignancy (except basal cell carcinoma)
- Impaired liver function (plasma ALAT > two times upper reference levels)
- Elevated amylase (plasma amylase > two times upper reference levels)
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, 18-64 years, 65+ 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.