Study on the Safety and Effectiveness of Oral Semaglutide for Patients with High Blood Sugar After Kidney Transplantation

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What is this study about?

This clinical trial is focused on studying the safety and effectiveness of a medication called oral semaglutide, which is marketed under the name Rybelsus. The study is specifically for patients who experience high blood sugar levels, known as hyperglycemia, after undergoing a kidney transplant. The trial will compare the effects of Rybelsus with a placebo, both used alongside the usual care that patients receive.

The main goal of the study is to determine if Rybelsus is as effective as the placebo in managing blood sugar levels in these patients. Participants in the study will take either Rybelsus or a placebo in the form of tablets. The study will last for a period of 14 days, during which the participants’ blood sugar levels will be closely monitored. This will help researchers understand how well the medication works in controlling blood sugar levels in patients who have had a kidney transplant.

Throughout the study, various health indicators will be observed, such as body weight, blood pressure, and kidney function. The study will also track any side effects or adverse events that participants may experience. The trial is expected to continue until September 2026, providing valuable insights into the management of high blood sugar in patients after kidney transplantation.

1 initial visit

Upon joining the clinical trial, you will have an initial visit with the study team. During this visit, your eligibility will be confirmed, and you will receive detailed information about the trial procedures.

You will be asked to provide written informed consent, which means you agree to participate in the study after understanding all the details.

2 baseline assessments

Baseline assessments will be conducted to gather information about your current health status. This includes measuring your blood glucose levels, body weight, blood pressure, and other relevant health indicators.

These assessments help establish a starting point for evaluating the effects of the treatment during the trial.

3 medication administration

You will be randomly assigned to receive either the active medication, Rybelsus (containing semaglutide), or a placebo. The medication is taken orally in tablet form.

The dosage of Rybelsus will start at 3 mg and may be increased to 7 mg and then to 14 mg, depending on your response and tolerance. The frequency and duration of administration will be explained by the study team.

4 regular follow-up visits

You will have regular follow-up visits with the study team. These visits are important for monitoring your health and the effects of the medication.

During these visits, various health parameters will be measured, including blood glucose levels, body weight, and blood pressure. You will also be asked about any side effects or changes in your health.

5 continuous glucose monitoring

Throughout the trial, your blood glucose levels will be continuously monitored using a device called a continuous glucose monitor (CGM). This device tracks your glucose levels throughout the day and night.

The data collected from the CGM will help assess how well the medication is managing your blood glucose levels.

6 final assessment

At the end of the trial, a final assessment will be conducted to evaluate the overall effects of the treatment on your health.

This assessment will include a comprehensive review of your health parameters, including blood glucose levels, body weight, and any side effects experienced during the trial.

Who Can Join the Study?

Provide written informed consent before any trial-related procedures are performed. This means you agree to participate after being informed about the study.
Be a male or female aged between 18 and 80 years.
Have a diagnosis of post-transplant hyperglycaemia 10 to 15 days after kidney transplantation. This means your blood sugar levels are high after receiving a kidney transplant. Specifically, your fasting plasma glucose should be at least 7.0 mmol/L, or your plasma glucose should be at least 11.1 mmol/L after a glucose tolerance test.
Have an eGFR (estimated glomerular filtration rate) greater than 15 ml/min/1.73 m² 10 to 15 days after kidney transplantation. This is a measure of how well your kidneys are working.
Be willing and able to follow the trial protocol. This means you agree to follow the study’s rules and procedures.

Who Cannot Join the Study?

Patients who have not had a kidney transplant cannot participate.
Patients who do not have high blood sugar levels after a kidney transplant cannot participate.
Patients who are under 18 years old cannot participate.
Patients who are over 75 years old cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of severe allergic reactions to the study medication cannot participate.
Patients who are currently participating in another clinical trial cannot participate.
Patients with any other medical condition that the study doctors think might make it unsafe for them to participate cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Aarhus University	Aarhus	Denmark
Rigshospitalet	Copenhagen	Denmark
Odense University Hospital	Odense	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2023

Trial locations

Investigated drugs:

Oral Semaglutide (Rybelsus) is a medication used in this clinical trial to help manage blood sugar levels in patients who have high blood sugar after receiving a kidney transplant. It is taken by mouth and works by helping the body produce more insulin, which helps lower blood sugar levels. The goal of using this medication in the trial is to see if it can effectively control blood sugar without causing harm, compared to a placebo, when added to the usual care that patients receive.

Investigated diseases:

Hyperglycemia after renal transplantation – This condition occurs when there is an elevated level of glucose in the blood following a kidney transplant. It can develop due to the use of immunosuppressive medications, which are necessary to prevent organ rejection but can affect glucose metabolism. The progression involves fluctuations in blood sugar levels, which may lead to periods of high glucose. Over time, persistent hyperglycemia can affect the function of the transplanted kidney and other organs. Monitoring and managing blood glucose levels are crucial to prevent complications. The condition requires careful observation to maintain glucose within a target range.

Trial ID:

2023-504159-29-01

NCT ID:

NCT05702931

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety and Effectiveness of Oral Semaglutide for Patients with High Blood Sugar After Kidney Transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?