Study on Patiromer and Placebo for Managing Hyperkalemia in Non-Dialysis Patients with Chronic Kidney Disease Stages IIIB to V

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What is this study about?

This clinical trial is focused on studying a condition called hyperkalemia, which is when there is too much potassium in the blood. This condition is being studied in patients with Chronic Kidney Disease (CKD) at stages IIIB to V, who are not on dialysis. The trial will test a treatment called patiromer, which is a powder taken by mouth, and compare it to a placebo. The purpose of the study is to see how well patiromer works in helping patients continue their current kidney treatment without needing to stop or reduce their RAAS inhibitor therapy, which is a type of medication that helps protect the kidneys and heart.

During the study, participants 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 treatment or the placebo. The trial will monitor the participants’ potassium levels and other health markers over time to see if patiromer helps maintain safe potassium levels and allows patients to continue their RAAS inhibitor therapy. The study will also look at other health factors, such as kidney function and overall quality of life, to understand the broader effects of the treatment.

The trial will last for several months, with regular visits to check on the participants’ health and adjust treatments as needed. The goal is to gather information on how effective and safe patiromer is for managing hyperkalemia in patients with advanced CKD, potentially offering a new way to help these patients maintain their kidney health and treatment regimen.

1 joining the study

Upon joining the study, you will be asked to provide informed consent. This means you agree to participate after understanding the study’s purpose and procedures.

You must be over 18 years old and have a glomerular filtration rate (GFR) of less than 45 ml/min/1.73m², which indicates stages 3b to 5 of chronic kidney disease (CKD).

2 initial assessments

Your serum potassium levels will be checked. They must be above 5.0 mEq/L in at least two evaluations, one week apart, despite dietary counseling and other treatments.

Your serum magnesium levels will also be checked to ensure they are within the normal range.

3 randomization

You will be randomly assigned to receive either patiromer or a placebo. This is a double-blind study, meaning neither you nor the researchers will know which treatment you are receiving.

4 treatment phase

If assigned to the patiromer group, you will take Veltassa 8.4 g powder for oral suspension. This medication is taken orally.

The treatment aims to manage hyperkalemia, which is a high level of potassium in the blood, and to evaluate the need for changes in your current RAAS inhibitor therapy.

5 follow-up visits

You will have regular follow-up visits to monitor your serum potassium levels and other health markers.

These visits will help determine if there is a need to withdraw or reduce your RAAS inhibitor therapy due to persistent high potassium levels.

6 end of study

The study is expected to end by June 15, 2025. At the end of the study, your overall health and treatment outcomes will be evaluated.

The results will help understand the effectiveness of patiromer compared to placebo in managing hyperkalemia in CKD patients.

Who Can Join the Study?

Provide informed consent before any study-specific procedures. This means you agree to participate after understanding the study details.
Be older than 18 years.
Have a GFR (a measure of kidney function) less than 45 ml/min/1.73m², which indicates Chronic Kidney Disease (CKD) Stage 3b to 5, but not require dialysis.
Have a serum potassium level greater than 5.0 mEq/L in at least two tests taken one week apart, despite following dietary advice, managing metabolic acidosis (a condition where there is too much acid in the body fluids), using diuretics (medications that help remove excess fluid) for blood pressure and fluid balance, and controlling blood sugar if diabetic.
Have normal serum magnesium levels.
Be on RAAS inhibitors therapy, which includes medications like ACE inhibitors, ARBs, and aldosterone antagonists (such as spironolactone and finerenone). These medications help manage blood pressure and heart function.

Who Cannot Join the Study?

Patients who are currently on dialysis treatment cannot participate.
Patients with a history of severe allergic reactions to the study medication or similar medications are excluded.
Patients with a medical condition that the study doctors believe would make it unsafe for them to participate are not allowed.
Pregnant or breastfeeding women cannot take part in the study.
Patients who are participating in another clinical trial at the same time are not eligible.
Patients with a history of drug or alcohol abuse that could interfere with the study results are excluded.
Patients who have had a heart attack or stroke within the last 6 months cannot participate.
Patients with uncontrolled high blood pressure are not eligible.
Patients with severe liver disease are excluded from the study.
Patients with a history of certain types of cancer within the last 5 years cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Istituto Di Ricerche Farmacologiche Mario Negri	Ranica	Italy

Trial status

Country	Status	Recruitment Start
Italy	Not recruiting	15.06.2023

Trial locations

Investigated drugs:

Patiromer is a medication used to help manage high levels of potassium in the blood, a condition known as hyperkalemia. In this clinical trial, patiromer is being tested to see if it can help patients with chronic kidney disease (CKD) who are not on dialysis. The goal is to see if patiromer can prevent the need to stop or reduce the dose of other important medications that help protect the kidneys and heart, known as RAAS inhibitors, which can sometimes cause high potassium levels.

Investigated diseases:

Hyperkalaemia

Hyperkalemia – Hyperkalemia is a condition characterized by elevated levels of potassium in the blood. It often occurs when the kidneys are unable to excrete potassium efficiently, which can happen in chronic kidney disease (CKD) stages IIIB to V. As potassium levels rise, it can affect the function of muscles and nerves, potentially leading to muscle weakness, fatigue, and irregular heartbeats. The progression of hyperkalemia can be gradual, especially in chronic conditions, but it can also occur suddenly if there is a rapid increase in potassium intake or a sudden decrease in kidney function. In severe cases, it can disrupt the electrical activity of the heart, leading to more serious complications. Monitoring and managing potassium levels is crucial to prevent these adverse effects.

Trial ID:

2023-503984-41-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Patiromer and Placebo for Managing Hyperkalemia in Non-Dialysis Patients with Chronic Kidney Disease Stages IIIB to V

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