Study on the Effect of Patiromer on Vascular Health in Patients with Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of a medication called patiromer on people with chronic kidney disease (CKD). Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste from the blood. The study will compare the effects of patiromer, which is a powder taken by mouth, with a placebo, which looks like the medication but does not contain the active ingredient. The purpose of the study is to understand how patiromer affects blood vessel function and the balance of minerals in the body.

Participants in the study will be randomly assigned to receive either patiromer or a placebo. The study is designed to be “double-blind,” meaning neither the participants nor the researchers will know who is receiving the actual medication or the placebo. This helps ensure that the results are not influenced by expectations. The study will last for a set period, during which participants will take the medication or placebo and attend regular check-ups to monitor their health and any changes in their condition.

The researchers will focus on measuring changes in blood vessel health, such as how stiff the arteries are, and will also look at various markers related to mineral metabolism, like levels of calcium and phosphate in the blood. Other aspects of kidney health, such as blood pressure and kidney function, will also be monitored. The study aims to provide valuable information on how patiromer might help manage chronic kidney disease and its related complications.

1 joining the study

Upon joining the study, the patient will be informed about the trial’s purpose, which is to determine the effect of patiromer on vascular function and mineral metabolism in individuals with chronic kidney disease.

The patient will be required to provide informed consent, confirming their understanding of the study procedures and their willingness to participate.

2 initial assessment

The patient will undergo an initial assessment to confirm eligibility. This includes verifying that the patient is 18 years or older, has chronic kidney disease with specific kidney function levels, and has potassium levels between 5 and 6 mEq/L.

The patient must have been on certain medications, such as ACE inhibitors, ARBs, or aldosterone antagonists, for at least one month prior to the screening.

3 randomization

The patient will be randomly assigned to receive either the active drug, patiromer, or a placebo. This process is double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

4 treatment phase

The patient will take the assigned treatment orally. If receiving patiromer, the dosage will be 8.4 grams of powder for oral suspension, taken as directed by the study team.

The treatment will be administered by mixing the powder with water, apple juice, or cranberry juice, and taken as instructed.

5 monitoring and follow-up

Throughout the trial, the patient will have regular follow-up visits to monitor health and response to the treatment. This includes measuring changes in arterial stiffness, blood pressure, and other health indicators.

The patient will also provide blood and urine samples to assess mineral metabolism and kidney function.

6 completion of the trial

At the end of the trial, the patient will have a final assessment to evaluate the overall effects of the treatment.

The patient will be informed about the study’s findings and any implications for their health.

Who Can Join the Study?

Must be 18 years or older, and can be of any gender.
Have chronic kidney disease, which is a long-term condition where the kidneys do not work as well as they should. This is defined by an eGFR (estimated glomerular filtration rate) between 15-60 ml/min/1.73m². The eGFR is a test that measures how well your kidneys are filtering.
Have potassium levels between 5 and 6 mEq/L in at least 2 out of 4 previous blood tests, and also have potassium levels between 5 and 6 mEq/L at the screening visit. Potassium is a mineral in your blood that is important for heart and muscle function.
Must be on treatment with ACEI (Angiotensin-Converting Enzyme Inhibitors), ARB (Angiotensin Receptor Blockers), or aldosterone antagonist therapy for at least one month before the screening. These are types of medications used to treat high blood pressure and heart failure, and to protect the kidneys.
Must be able to understand the study procedures and give informed consent to participate, meaning you agree to join the study after being fully informed about it.

Who Cannot Join the Study?

Patients with a history of allergic reactions to the study medication cannot participate. An allergic reaction is when your body reacts badly to something, causing symptoms like rash, itching, or trouble breathing.
Patients who are currently participating in another clinical trial are not eligible. This means you cannot be part of two studies at the same time.
Patients with uncontrolled high blood pressure cannot join. This means if your blood pressure is too high and not managed by medication or lifestyle changes, you cannot participate.
Patients with severe heart disease are excluded. Severe heart disease refers to serious conditions affecting the heart that may require special medical attention.
Patients who have had a stroke in the past 6 months cannot take part. A stroke is when blood flow to a part of your brain is stopped, causing brain cells to die.
Patients with liver disease that is not stable are not eligible. Liver disease affects how your liver works, and if it’s not stable, it means it’s not under control.
Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
Patients with active cancer are excluded. Active cancer means you are currently undergoing treatment or have cancer that is not in remission.
Patients with severe mental health disorders that are not controlled cannot join. This refers to serious mental health issues that are not being managed effectively with treatment.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hospital Universitario Reina Sofía	Cordoba	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	01.09.2023

Trial locations

Investigated drugs:

Patiromer

Patiromer is a medication used in this clinical trial to help manage the levels of potassium in the blood. It works by binding to potassium in the digestive tract, which helps to remove excess potassium from the body through the stool. This is particularly important for patients with chronic kidney disease (CKD), as their kidneys may not be able to remove enough potassium on their own. By helping to control potassium levels, patiromer may also have an effect on the health of blood vessels and the balance of minerals in the body, which is what this trial aims to investigate.

Investigated diseases:

Chronic kidney disease

Chronic Kidney Disease – Chronic Kidney Disease is a long-term condition characterized by a gradual loss of kidney function over time. The kidneys become less effective at filtering waste and excess fluids from the blood, which can lead to a buildup of harmful substances in the body. As the disease progresses, individuals may experience symptoms such as fatigue, swelling in the legs and ankles, and changes in urination patterns. The progression of the disease can lead to complications like high blood pressure, anemia, and bone disease. Over time, the kidneys may lose their ability to function adequately, requiring interventions to manage the condition. The disease is often detected through blood tests that measure kidney function and urine tests that check for protein or blood.

Trial ID:

2023-503941-69-00

Protocol code:

PATIvasc

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Patiromer on Vascular Health in Patients with Chronic Kidney Disease

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