Study of Sevuparin for Patients with Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying Chronic Kidney Disease (CKD), a condition where the kidneys gradually lose their ability to function properly. The trial will use a treatment called Sevuparin, which is administered as a sterile solution through a small injection under the skin. The purpose of the study is to explore how this treatment can help manage certain blood and kidney-related issues in people with CKD.

The study is divided into two parts. In the first part, researchers aim to develop a tool that helps determine the right dose of Sevuparin for each individual based on their kidney function. This is done by looking at how the body processes the medication. In the second part, the study will look at changes in important blood and kidney health markers after multiple doses of Sevuparin are given to participants with CKD. These markers include things like blood cell levels and kidney function indicators.

Throughout the study, participants will be closely monitored for safety, with regular checks on their heart activity, vital signs, and blood tests. The study will also assess any side effects that may occur. The goal is to gather information that could lead to better treatment options for people living with Chronic Kidney Disease.

1 joining the study

Upon joining the study, you will be required to provide a signed informed consent. This confirms your understanding of the study and your agreement to participate.

You will need to communicate effectively with the study team and comply with the study requirements.

2 initial assessment

An initial assessment will be conducted to ensure you meet the study criteria. This includes checking your body mass index (BMI) and body weight.

For patients with chronic kidney disease, your kidney function will be evaluated to determine the stage of your condition.

3 part 1 of the study

In Part 1, the study aims to develop a tool to help determine the appropriate dosage of the medication sevuparin based on your kidney function.

You will receive sevuparin as a sterile solution administered through a small injection under the skin (subcutaneous use).

4 part 2 of the study

In Part 2, the study will evaluate changes in your blood and kidney function after receiving multiple doses of sevuparin.

The medication will continue to be administered as a subcutaneous injection. The frequency and duration of administration will be determined based on your individual needs.

5 monitoring and assessments

Throughout the study, your health will be closely monitored. This includes regular checks of your vital signs, blood tests, and kidney function tests.

Any side effects or changes in your health will be recorded and assessed by the study team.

6 completion of the study

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

You will be informed about the study results and any further steps if necessary.

Who Can Join the Study?

Both healthy volunteers and patients must sign a form to show they understand the study and agree to participate.
Healthy volunteers must be men or women aged between 18 and 55 years old.
All participants must be able to communicate well with the study team in a language they understand and be able to follow the study requirements.
Healthy volunteers must not have any significant health issues found during a physical exam.
All participants must have a Body Mass Index (BMI) between 18.0 and 32.0 kg/m² and weigh at least 50 kg. BMI is a measure of body fat based on height and weight.
All participants must use a method of birth control as recommended by health guidelines.
Patients with chronic kidney disease (CKD) must be men or women aged 18 to 70 years old.
Patients must have moderate to severe kidney problems, classified as CKD Stage 3 (with an estimated glomerular filtration rate, or eGFR, of 30-45 mL/min/1.73m²) or Stage 4 and Stage 5 (eGFR 15-30 mL/min/1.73m² or requiring dialysis). eGFR is a test that measures kidney function.
In Part 2 of the study, patients in CKD Stage 4 and 5 must have anaemia, which means having low levels of haemoglobin in the blood: less than 12 g/dL for men and less than 11 g/dL for women. Haemoglobin is a protein in red blood cells that carries oxygen.
Patients must have a stable medication routine, meaning they have not started a new medication or changed the dose of their current medication within seven days or five half-lives before the first day of the study. A half-life is the time it takes for the amount of a drug in the body to reduce by half.

Who Cannot Join the Study?

Patients with any other serious medical condition that might affect their participation in the study.
Patients who are pregnant or breastfeeding.
Patients who have had a recent major surgery.
Patients who are currently participating in another clinical trial.
Patients with a history of allergic reactions to similar medications.
Patients with uncontrolled high blood pressure.
Patients with severe liver disease.
Patients with a history of drug or alcohol abuse.
Patients who are unable to comply with the study procedures.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Centro Ricerche Cliniche Di Verona S.r.l.	Verona	Italy
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione	Pavia	Italy

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	01.10.2024

Trial locations

Investigated drugs:

SEVUPARIN

Sevuparin is a medication being studied for its potential benefits in people with chronic kidney disease. It is designed to help improve kidney function and manage anemia, which is a common issue in kidney disease. The study aims to understand how the body processes sevuparin and how it affects kidney function and blood health. By doing so, researchers hope to find the best way to use this medication to help people with kidney problems. The goal is to tailor the treatment to each person’s needs based on their kidney function, making it more effective and safer for patients.

Investigated diseases:

Chronic kidney disease

Chronic kidney disease – Chronic kidney disease 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 impairment. As the disease progresses, waste products can accumulate in the body, leading to symptoms such as fatigue, swelling, and changes in urination. Over time, the kidneys may become less effective at maintaining the balance of minerals and electrolytes in the body. This can result in complications like high blood pressure and anemia. The progression of chronic kidney disease can vary, with some individuals experiencing a slow decline in kidney function, while others may progress more rapidly.

Trial ID:

2024-513864-24-00

Protocol code:

TCDK01

Trial Phase:

Therapeutic exploratory (Phase II)

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Study of Sevuparin for Patients with Chronic Kidney Disease

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