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
- Conditions
- Hyyperkalemia in CKD stage IIIB to V patientsMedDRA version: 21.1Level: PTClassification code: 10020646Term: Hyperkalaemia Class: 100000004861Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- CTIS2023-503984-41-00
- Lead Sponsor
- Mario Negri Institute For Pharmacological Research IRCCS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 1
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method