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Study on Patiromer for Improving RAAS Treatment in Patients with Chronic Kidney Disease Stages 3b/4

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Chronic Kidney Disease (CKD), specifically stages 3b and 4. The study aims to explore the effectiveness of a treatment called patiromer, which is a type of medication known as a non-absorbed, cation exchange polymer. This medication will be compared to a placebo to see if it can help improve the management of CKD by allowing for better use of RAAS-blocker treatments, which are medications that help control blood pressure and protect the kidneys.

Participants in the study will receive either patiromer or a placebo. The study will last for a period of up to 12 months. During this time, researchers will monitor the participants' kidney function and blood pressure. The main goal is to see if patiromer can help reduce the amount of protein in the urine, which is a sign of kidney damage, and to see if it allows for an increase in the dose of RAAS-blocker medications.

In addition to monitoring protein levels in the urine, the study will also look at other factors such as blood pressure, potassium levels in the blood, and overall kidney function. The study will help determine if patiromer is a beneficial treatment option for people with CKD who are taking RAAS-blocker medications. The results of this study could provide important information for improving the care of patients with chronic kidney disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on criteria such as age (18 years or older), stage of chronic kidney disease (CKD stage 3b-4), and other health parameters like blood pressure and serum potassium levels.
Step 2
Initial assessment
An initial assessment is conducted to establish baseline measurements. This includes evaluating kidney function, blood pressure, and albumin-creatinine ratio (ACR).
Step 3
Medication administration
The study involves the administration of patiromer and irbesartan. Patiromer is taken orally to help manage potassium levels. Irbesartan, also taken orally, is used to manage blood pressure and kidney function.
The dosage and frequency of these medications are determined by the study protocol and adjusted based on individual response and tolerance.
Step 4
Monitoring and adjustments
Regular monitoring of blood pressure, kidney function, and potassium levels is conducted throughout the study. Adjustments to medication dosages may be made to optimize treatment and manage any side effects.
Step 5
End of study assessment
At the end of each study period, a comprehensive assessment is performed. This includes measuring 24-hour urinary albumin excretion, blood pressure, and kidney function.
The primary endpoint is the change in albumin-creatinine ratio, while secondary endpoints include blood pressure and kidney function metrics.
Step 6
Completion of study
The study is estimated to conclude by October 1, 2025. Final results are analyzed to determine the effectiveness of patiromer in enabling the up-titration of RAAS-blocker treatment in patients with CKD.

Who can join the trial?

6 criteria

You must be at least 18 years old.
You should have chronic kidney disease at stage 3b or 4. This means your kidneys are not working as well as they should, with an eGFR (a test that measures kidney function) between 15 and 44 mL/min/1.73 m².
Your albumin-creatinine ratio should be greater than 30 mg/mmol. This is a test that checks for protein in your urine, which can be a sign of kidney problems.
Your systolic blood pressure (the top number in a blood pressure reading) should be higher than 130 mmHg, or you should be taking one or more medications to lower blood pressure.
Your serum potassium level should be between 4.0 and 5.0 mmol/L. This is a measure of the amount of potassium in your blood.
You should be taking a sub-maximal dose of ACE inhibitors or ARBs. These are types of medications used to treat high blood pressure and heart problems.

Who cannot join the trial?

10 criteria

Patients with other serious health conditions that could interfere with the study.
Patients who are unable to follow the study procedures or take the study medication as required.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial recently.
Patients with a history of allergic reactions to the study medication or similar drugs.
Patients with severe liver disease.
Patients with uncontrolled high blood pressure.
Patients with a history of drug or alcohol abuse.
Patients with certain heart conditions that could pose a risk during the study.
Patients who have had a kidney transplant.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

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Amsterdam UMC
Amsterdam, The Netherlands
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Frisius
Heerenveen, The Netherlands
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Isala Klinieken Stichting
Zwolle, The Netherlands

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Investigated drugs

Patiromer is a medication used to help manage potassium levels in the blood. In this clinical trial, it is being tested to see if it can help patients with chronic kidney disease (CKD) better tolerate medications that block the renin-angiotensin-aldosterone system (RAAS). By managing potassium levels, patiromer may allow for higher doses of RAAS-blocker treatments, which could lead to a reduction in albuminuria, a condition where there is too much protein in the urine, indicating kidney damage.

What is already known about the treatment

Patiromer – Patiromer is administered orally in the form of a powder that is mixed with water. It is currently being studied in clinical trials for its effectiveness in managing chronic kidney disease, particularly in patients with stages 3b and 4. The main therapeutic indication for patiromer is to help control high potassium levels in the blood, which can be a complication of kidney disease. At the molecular level, patiromer works by binding to potassium in the gastrointestinal tract, preventing its absorption into the bloodstream. It is classified as a potassium binder, which helps maintain normal potassium levels and supports the use of RAAS-blocker treatments in kidney disease management.

Investigated diseases

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, with stage 3b/4 indicating moderate to severe loss of kidney function. As the disease advances, waste products can build up in the body, leading to symptoms such as fatigue, swelling, and changes in urination. The progression can also affect blood pressure regulation and electrolyte balance. Over time, the kidneys' reduced function can impact overall health, requiring careful management to slow further decline.