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, also known as Rybelsus, in patients who experience high blood sugar levels, or hyperglycemia, after receiving a kidney transplant. The study aims to determine if oral semaglutide, when compared to a placebo, can effectively manage blood sugar levels in these patients. The medication is taken in the form of tablets and is used alongside the standard care that patients are already receiving.

Participants in the study will be given either oral semaglutide or a placebo, and their blood sugar levels will be monitored over a period of time. The study will assess how well the medication helps in maintaining blood sugar within a target range and will also look at other health indicators such as body weight, blood pressure, and kidney function. The trial will also monitor any side effects or adverse events that may occur during the treatment period.

The study is expected to continue until 2026, and it will provide valuable information on the potential benefits and risks of using oral semaglutide in managing hyperglycemia in patients who have undergone a kidney transplant. This research could help improve treatment options for these patients in the future.

1 initial visit

Upon joining the study, you will have an initial visit where you will be asked to provide written informed consent. This means you agree to participate after understanding the trial details.

During this visit, your eligibility will be confirmed. This includes checking your age, diagnosis of hyperglycaemia after renal transplantation, and other health criteria.

2 baseline assessments

Baseline assessments will be conducted to gather initial health data. This includes measuring fasting plasma glucose levels, kidney function, and other vital signs.

You may undergo a continuous glucose monitoring (CGM) to evaluate your glucose levels over time.

3 medication administration

You will be randomly assigned to receive either oral semaglutide (Rybelsus) or a placebo. The semaglutide comes in tablet form with dosages of 3 mg, 7 mg, or 14 mg.

The medication is taken orally once daily. The specific dosage and duration will be determined by the study protocol.

4 regular follow-up visits

Regular follow-up visits will be scheduled to monitor your health and the effects of the medication. These visits will include assessments similar to the baseline assessments.

Your glucose levels, kidney function, and other health indicators will be regularly checked.

5 monitoring and reporting

Throughout the trial, you will be asked to report any side effects or changes in your health. This includes any gastrointestinal symptoms or hypoglycaemic episodes.

You will also be monitored for any serious adverse events or changes in your kidney function.

6 end of trial assessments

At the end of the trial, final assessments will be conducted to evaluate the overall effects of the medication on your health.

This will include a comprehensive review of your glucose levels, kidney function, and any other relevant health data.

Who Can Join the Study?

Written informed consent must be obtained before any trial-related procedures are performed. This means you need to agree in writing to participate in the study after being informed about it.
You must be a male or female aged between 18 and 80 years.
You must have a diagnosis of post-transplant hyperglycaemia (high blood sugar after a kidney transplant) 10 to 15 days after the transplant. This is defined as having a fasting plasma glucose level of 7.0 mmol/L or higher, or a plasma glucose level of 11.1 mmol/L or higher after a glucose tolerance test.
Your eGFR (estimated glomerular filtration rate, a measure of kidney function) must be greater than 15 ml/min/1.73 m², 10 to 15 days after the kidney transplant.
You must be willing and able to follow the trial protocol, which means you agree to follow the study’s rules and procedures.

Who Cannot Join the Study?

Patients who have not undergone a kidney transplant cannot participate.
Patients who do not have high blood sugar levels after a kidney transplant are excluded.
Individuals who are not within the specified age range for the study cannot join. The study is for adults only.
Patients who are part of a vulnerable population, meaning they need special protection, are not eligible.
Patients who are not able to take oral medications, which are medicines taken by mouth, cannot participate.
Individuals who are not able to follow the study procedures or instructions are excluded.

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	Not yet recruiting	01.09.2023

Trial locations

Investigated drugs:

Oral Semaglutide (Rybelsus) is a medication used to help control blood sugar levels in people with high blood sugar, especially after a kidney transplant. It works by helping the body release the right amount of insulin when blood sugar levels are high. This medication is taken by mouth and is part of a treatment plan that includes diet and exercise to help manage blood sugar levels effectively.

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 can lead to periods of high glucose. Over time, if not managed, it can affect the function of the transplanted kidney and overall health. 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:

2023-504159-29-00

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?

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