non-absorbed, cation exchange polymer for Chronic kidney disease (stage 3b-4)

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years\n- CKD stage 3b-4 (eGFR 15-44 mL/min/1.73 m2 - Albumin-creatinine ratio >3 mg/mmol - Systolic blood pressure >130 mmHg or use of one or more antihypertensive drugs\n- Serum K+ 4.0-5.0 mmol/L\n- On sub-maximal dose ACEi/ARB"}

Exclusion criteria

• {"criterion_text":"- Prior ACEi/ARB dose reduction due to a drop in eGFR by >25% in the last year\n- history of severe hyperkalaemia (>6.0 mmol/L) in the last year\n- pregnancy or breastfeeding\n- life expectancy <12 months"}

Primary endpoints

• {"endpoint_text":"- The main trial endpoint is 24-hour urinary albumin excretion, adjusted for creatinine (albumin-creatinine ratio, ACR), at the end of each study period.","definition_or_measurement_approach":"24-hour urinary albumin excretion adjusted for creatinine (albumin-creatinine ratio, ACR) measured at the end of each study period."}

Secondary endpoints

• {"endpoint_text":"- The main secondary endpoint is systolic and diastolic blood pressure, assessed by a 24-hour ambulatory blood pressure measurement at the end of each study period. Further secondary endpoints are plasma potassium levels, kidney function, as reflected by the estimated glomerular filtration rate (eGFR) using the combined cystatin C-creatinine-based CKD-EPI formula, the achieved irbesartan dose and the number of (sever) adverse events at the end of each study period.","definition_or_measurement_approach":"Systolic and diastolic blood pressure assessed by 24-hour ambulatory blood pressure measurement at the end of each study period; plasma potassium levels; kidney function via eGFR using the combined cystatin C-creatinine-based CKD-EPI formula; recorded achieved irbesartan dose; count of (severe) adverse events at the end of each study period."}

Netherlands

Earliest CTIS Part Ii Submission Date

10-01-2024

Latest Decision Or Authorization Date

12-05-2025

Processing Time Days

488

Number Of Sites

4

Number Of Participants

44

Primary sponsor

Full Name

University Medical Center Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands