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A Prospective, double-blind, randomized, single centre trial to evaluate the rate of RAAS inhibitor withdrawal or down-titration in non-dialysis patients with CKD stage IIIB to Vrandomized to Patiromer or placebo
EU CTIS ID: 2023-503984-41-00
What this study is testing
To compare the effects of patiromer and placebo on the rate of withdrawal or down-titration of RAAS inhibition therapy because of refractory hyperkalemia (serum K+ levels ≥ 5.5 mEq/L at two consecutive visits one-week apart) in non-dialysis patients with CKD stage IIIB to V receiving best available conservative therapy, including RAAS inhibition with ACE inhibitors and/or ARBs and/or aldosterone antagonists
- Therapeutic confirmatory (Phase III)
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
- Provision of informed consent prior to any study specific procedures
- Age >18 years
- GFR <45 ml/min/1.73m2, as per CKD-EPI equation (CKD Stage 3b to 5) not requiring dialysis therapy
- Serum potassium >5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics
- Serum magnesium levels in normal range
- Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone)
You likely can't join if
- Serum potassium >6.0 mEq/L and/or any clinical signs or symptoms of hyperkalemia (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics
- Patients with or at risk of hypercalcaemia and/or hypomagnesaemia
- Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months
- Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic)
- Positive hepatitis C antibodies, hepatitis B virus surface antigens at screening
- Known to have tested positive for human immunodeficiency virus
See the full eligibility criteria
- Provision of informed consent prior to any study specific procedures
- Age >18 years
- GFR <45 ml/min/1.73m2, as per CKD-EPI equation (CKD Stage 3b to 5) not requiring dialysis therapy
- Serum potassium >5.0 mEq/L (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics
- Serum magnesium levels in normal range
- Concomitant therapy with RAAS inhibitors (ACE inhibitors, ARBs and aldosterone antagonists, such as spironolactone and finerenone)
- Serum potassium >6.0 mEq/L and/or any clinical signs or symptoms of hyperkalemia (in at least two consecutive evaluations, one week apart) despite dietary counseling, optimized metabolic acidosis control, diuretic therapy as needed for blood pressure control and fluid balance, and effective blood glucose control in diabetics
- Patients with or at risk of hypercalcaemia and/or hypomagnesaemia
- Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months
- Refractory severe hypertension (BP >180/100 mmHg despite optimized pharmacological treatment with at least three blood pressure-lowering medications and a diuretic)
- Positive hepatitis C antibodies, hepatitis B virus surface antigens at screening
- Known to have tested positive for human immunodeficiency virus
- Drug or alcohol abuse
- Female subjects who are pregnant, lactating or who intend to become pregnant before or during the study period, or within 90 days of the last dose of study treatment. Female subjects who intend to donate ova over the same time period
- Male subjects who intend to donate sperm during the study period or for the 90 days following the last dose of study treatment
- Male and female subjects in childbearing age not using a highly effective contraception method according to the 2020 CTFG Recommendations related to contraception and pregnancy testing in clinical trials
- Inability to fully understand the potential risks and benefits related to study participation
- Ongoing treatment with SPS before randomization* *Patient eligibility could be reassessed during the screening period after at least one week from SPS therapy withdrawal
- Involvement in the study planning and/or conduct
- Participation in another clinical study with an investigational product during the last month
- Uncontrolled metabolic acidosis* or respiratory acidosis *Patient eligibility could be reassessed during the screening period after appropriate correction of metabolic acidosis by sodium bicarbonate supplementation and other other interventions as deemed clinically appropriate as per clinical practice
- History of bowel obstruction or major gastrointestinal surgery, severe gastrointestinal disorders, or swallowing disorders
- Marginal kidney function and/or marginal urine output or any other condition requiring urgent potassium lowering
- Rapidly progressive kidney disease (eGFR reduction ≥ 30% over the last three months as per CKD-EPI equation) and expected risk of progression to ESKD and need of renal replacement therapy by dialysis or transplantation within six months
- Active systemic autoimmune diseases
- Concomitant treatment with steroids or any other immunosuppressive agent
- Hypersensitivity to the active ingredient or any of the excipients. Patients with Hereditary Fructose Intolerance
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, 18-64 years, 65+ 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.