Study on the Effects of Dapagliflozin on Kidney Health in Patients with Chronic Kidney Disease After Kidney Transplantation

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What is this study about?

This clinical trial is focused on studying the effects of the medication dapagliflozin on patients who have undergone a kidney transplant and are experiencing Chronic Kidney Disease (CKD). The medication being tested is known as Forxiga 10 mg film-coated tablets. The purpose of the study is to analyze how this medication affects the kidney’s structure and blood flow in patients with reduced kidney function one year after their kidney transplant.

Participants in the study will be randomly assigned to receive either the medication or a placebo. The study will observe changes in the kidney’s structure, specifically looking at certain cells and markers that indicate inflammation and stress within the kidney tissue. These observations will be made during a routine biopsy, which is a procedure where a small sample of kidney tissue is taken for examination, one year after the kidney transplant.

The study will last for a period of 12 months, during which the effects of dapagliflozin on the kidney will be closely monitored. The goal is to understand whether this medication can help improve kidney health in patients who have received a kidney transplant and are dealing with Chronic Kidney Disease.

1 joining the study

Upon joining the study, the patient must provide written consent to participate.

Eligibility criteria include being between 18 and 75 years old, having a stable kidney function 9 months after transplantation, and for females of childbearing potential, using adequate contraceptive precautions and having a negative pregnancy test.

2 medication administration

The patient will be administered Forxiga 10 mg, which contains the active substance dapagliflozin.

The medication is taken orally in the form of a film-coated tablet.

3 monitoring and assessments

Throughout the study, the patient will undergo regular monitoring to assess the effects of the medication on kidney structure and function.

This includes evaluating kidney tissue samples for changes in cell structure, inflammation, and oxidative stress markers during the routine one-year follow-up biopsy.

4 study duration

The study is expected to conclude by December 31, 2025.

The patient will be involved in the study activities until this date, unless otherwise specified by the study protocol.

Who Can Join the Study?

Patients must be between 18 and 75 years old.
Patients must have had a kidney transplant and have a stable kidney function, 9 months after the transplant, regardless of whether they have diabetes or not.
Women who can have children must use effective birth control methods.
Women who can have children or are within two years of menopause must have a negative urine pregnancy test at the screening visit.
Patients must provide written consent to participate in the study.

Who Cannot Join the Study?

Patients who do not have Chronic Kidney Disease (CKD) cannot participate. CKD is a condition where the kidneys are damaged and can’t filter blood as well as they should.
Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
Both male and female patients are eligible, so exclusion is not based on gender.
Patients who are considered part of a vulnerable population may be excluded. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Universitaetsklinikum Erlangen AöR	Erlangen	Germany

Trial status

Country	Status	Recruitment Start
Germany	Recruiting	01.07.2023

Trial locations

Investigated drugs:

Dapagliflozin

Dapagliflozin is a medication used in this clinical trial to study its effects on kidney structure and function in patients who have received a kidney transplant. The trial aims to see how this medication affects the kidney’s cells and tissues, particularly focusing on inflammation and stress markers. Dapagliflozin is typically used to help control blood sugar levels in people with diabetes, but in this study, researchers are exploring its potential benefits for kidney health after transplantation.

Chronic Kidney Disease – Chronic Kidney Disease (CKD) is a long-term condition where the kidneys gradually lose their ability to filter waste and excess fluids from the blood. This disease progresses through stages, starting with mild damage and potentially advancing to severe kidney failure. As the kidneys become less effective, waste products and fluids can build up in the body, leading to symptoms such as swelling, fatigue, and high blood pressure. Over time, CKD can affect other body systems, including the heart and blood vessels. The progression of CKD can vary among individuals, with some experiencing a slow decline in kidney function, while others may progress more rapidly. Regular monitoring and lifestyle adjustments are often necessary to manage the condition and slow its progression.

Trial ID:

2024-517885-40-00

Protocol code:

Dapa-TxV1.0

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on the Effects of Dapagliflozin on Kidney Health in Patients with Chronic Kidney Disease After Kidney Transplantation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?