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Study on Dapagliflozin and Balcinrenone for Patients Over 50 with Stage 3 Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of certain medications on people with chronic kidney disease, specifically those in stage 3. The study involves two main medications: dapagliflozin and balcinrenone. Dapagliflozin is a type of medication known as an SGLT2 inhibitor, which helps the kidneys remove glucose from the body. Balcinrenone, also known by its code name AZD9977, is a synthetic small molecule that is being tested for its potential benefits in kidney disease. Some participants will receive a placebo, which is a substance with no active medication, to compare the effects of the actual drugs.

The purpose of the study is to explore how these medications, either alone or in combination, affect the body’s handling of fluids and electrolytes, as well as energy metabolism. Participants in the study will be over 50 years old and will have their kidney function monitored. The study will last for a period of up to 32 weeks, during which participants will take the medications orally in the form of tablets or capsules. The researchers aim to see if balcinrenone can maintain the beneficial effects of dapagliflozin on kidney function, particularly in terms of glucose excretion.

Throughout the study, various health markers will be measured, such as changes in urine glucose levels, muscle water content, and other indicators of kidney and metabolic health. These measurements will help determine the effectiveness and safety of the treatments. The study will also monitor any side effects that may occur during the treatment period. By the end of the study, the researchers hope to gain a better understanding of how these medications can help manage chronic kidney disease and improve patient outcomes.

1 joining the study

Upon joining the study, eligibility is confirmed based on age, kidney function, and other health criteria.

Participants must be over 50 years old and have stage 3 chronic kidney disease.

2 randomization

Participants are randomly assigned to receive either dapagliflozin, balcinrenone, a combination of both, or a placebo.

This process ensures that the study results are unbiased.

3 medication administration

Participants take the assigned medication orally in capsule form.

The duration and frequency of administration are determined by the study protocol.

4 monitoring and assessments

Participants undergo regular monitoring to assess changes in urine glucose excretion, urine osmolality, and other parameters.

Assessments occur at specific intervals, such as day 3 and day 28.

5 safety evaluations

Safety evaluations are conducted to monitor any adverse effects and changes in vital signs.

These evaluations help ensure participant safety throughout the study.

6 completion of the study

The study concludes after all assessments and evaluations are completed.

Participants may receive information about the study results and their health status.

Who Can Join the Study?

  • Patients must be over 50 years old.
  • Must have a diagnosis of chronic kidney disease with a specific kidney function level, known as eGFR, between 30 and 60.
  • For patients in Germany, potassium levels in the blood should be between 3.5 and 5.0, or within normal ranges if provided, checked within 2 weeks before starting the study.
  • For patients in France, potassium levels in the blood should be between 3.5 and 5.0, checked within 2 weeks before starting the study.
  • Sodium levels in the blood should be within normal reference values within 2 weeks before starting the study.
  • If patients have type 2 diabetes, they can be on certain diabetes medications like metformin, sulphonylureas, or DPP4 inhibitors, alone or in combination, with or without insulin. If used, the dose should be stable for 12 weeks before starting the study.
  • No changes in other treatments for at least 3 weeks before starting the study.
  • Body mass index (BMI) should be less than 40. BMI is a measure of body fat based on height and weight.
  • For women who can have children, a negative pregnancy test is required, and they must agree to use effective birth control.
  • Participants must be willing to join the study and able to provide signed informed consent, which means they understand and agree to follow the study’s rules and requirements.

Who Cannot Join the Study?

  • Patients with Stage 3 chronic kidney disease cannot participate. This means their kidneys are not working as well as they should, but they are not in the most severe stage.
  • Patients who are not within the specified age range for the study cannot participate. The study is looking for people in certain age groups.
  • Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with certain characteristics or conditions.
  • Both male and female patients can participate, but if someone does not fit the gender criteria, they cannot join.
  • Patients who are considered part of a vulnerable population cannot participate. This means people who might need extra protection or care are not included in the study.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

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Other Sites

Site Name City Country Status
Klinikum Nuernberg Nürnberg Germany
Ajgsjqxhdk Pyyaedpv Hkiefoez Dt Mwuokokou Marseille France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
01.02.2023
Germany Germany
Not recruiting
01.02.2023

Trial locations

Investigated drugs:

Dapagliflozin is a medication used to help control blood sugar levels in people with chronic kidney disease. It works by helping the kidneys remove glucose from the bloodstream, which can also aid in managing body fluid and electrolyte balance.

Balcinrenone is a medication being studied for its potential to support kidney function. In this trial, it is being tested to see if it can enhance the effects of dapagliflozin, particularly in maintaining the beneficial increase in glucose excretion by the kidneys.

Stage 3 Chronic Kidney Disease – This condition is characterized by a moderate decrease in kidney function, where the kidneys are not filtering blood as well as they should. It is typically identified by a reduction in the glomerular filtration rate (GFR) to between 30 and 59 mL/min/1.73 m². As the disease progresses, waste products can build up in the blood, leading to symptoms such as fatigue, swelling in the legs, and changes in urination patterns. Patients may also experience high blood pressure and bone health issues due to imbalances in minerals and hormones. The progression of the disease can vary, and it may remain stable for some time or gradually worsen. Regular monitoring and lifestyle adjustments are often necessary to manage the condition.

Trial ID:
2024-516032-10-00
Protocol code:
CT114-2022-01
Trial Phase:
Therapeutic exploratory (Phase II)

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