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Double-blind, placebo-controlled clinical trial to determine the effect of Patiromer on vascular function and its relationship with mineral metabolism parameters
EU CTIS ID: 2023-503941-69-00
What this study is testing
To determine the effect of treatment with patiromer on vascular function and mineral metabolism in patients with CKD
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 18 years and older of both sexes.
- Chronic kidney disease, defined by an eGFR 15-60 ml/min/1.73m2 estimated using the CKD-EPI equation
- Potassium levels between 5 and 6 mEq/L in at least 2 of 4 previous blood test results and potassium level between 5 and 6 mEq/L at screening visit
- Must be on ACEI or ARB or aldosterone antagonist therapy for at least one month prior to screening at the highest tolerated dose.
- Patient capable of understanding the study procedures and who gives their informed consent to participate
You likely can't join if
- Episodes of known clinically significant cardiac arrest or ventricular arrhythmias
- Current use of polymer-based drugs such as cholestyramine, coveselam, or sodium polystyrene sulfonate
- History of gastroparesis or intestinal obstruction, swallowing disorders, or major gastrointestinal surgery
- History of stroke, myocardial infarction, decompensated heart failure, percutaneous coronary intervention or coronary bypass in the last 3 months
- Patients with severe physical or mental disabilities that, in the opinion of the investigator, could interfere with the fulfillment of the study requirements
- Presence of any condition that, in the opinion of the investigator, puts the patient at risk or could potentially impair the quality of the data
See the full eligibility criteria
- 18 years and older of both sexes.
- Chronic kidney disease, defined by an eGFR 15-60 ml/min/1.73m2 estimated using the CKD-EPI equation
- Potassium levels between 5 and 6 mEq/L in at least 2 of 4 previous blood test results and potassium level between 5 and 6 mEq/L at screening visit
- Must be on ACEI or ARB or aldosterone antagonist therapy for at least one month prior to screening at the highest tolerated dose.
- Patient capable of understanding the study procedures and who gives their informed consent to participate
- Episodes of known clinically significant cardiac arrest or ventricular arrhythmias
- Current use of polymer-based drugs such as cholestyramine, coveselam, or sodium polystyrene sulfonate
- History of gastroparesis or intestinal obstruction, swallowing disorders, or major gastrointestinal surgery
- History of stroke, myocardial infarction, decompensated heart failure, percutaneous coronary intervention or coronary bypass in the last 3 months
- Patients with severe physical or mental disabilities that, in the opinion of the investigator, could interfere with the fulfillment of the study requirements
- Presence of any condition that, in the opinion of the investigator, puts the patient at risk or could potentially impair the quality of the data
- Drug or alcohol addiction that, in the investigator's opinion, could interfere with compliance with study requirements
- Inability or unwillingness of the individual or legal guardian or representative to give written informed consent
- Previous kidney or heart transplant
- Severe hypomagnesemia (<1.4 mg/dl)
- Active cancer, excluding non-melanocytic skin cancer, considered already cured
- Treatment with anticancer drugs or immunotherapy
- Pregnant or lactating women
- History of drug or alcohol abuse
- Continuous use of potassium supplements in the month prior to screening
- Current use of calcium-containing or calcium-free phosphate chelators
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.