Rapid and Simultaneous Initiation of Four Guideline-Directed CKD Therapies (RAPID-CKD)

Number of participants enrolled per month

Proportion of participants initiating all four therapies within 8 weeks

Proportion of participants who permanently discontinue one or more therapies

Incidence of potassium levels greater than 5.5 to less than or equal to 6.0 mmol/L

Incidence of potassium levels greater than 6.0 mmol/L

Incidence of acute kidney injury (AKI) events (persistent estimated glomerular filtration rate decline ≥30% without return to \<30% with drug discontinuation; or hospitalization with diagnosis of AKI related to medications) during the study period

Incidence of progression to end-stage kidney disease (initiation of chronic dialysis \[hemo- or peritoneal dialysis\] for ≥90 days or kidney transplantation, or persistent \[≥2 values, including the last value if not on dialysis or transplant\] estimated glomerular filtration rate \<15 mL/min/1.73m\^2)

Number of participants with permanent discontinuation of one or more study drugs not due to study completion or death.

Rate of change in estimated glomerular filtration rate over the 6-month study period

Change in glycated hemoglobin (HbA1c) levels from baseline

Number of participants achieving \>30% reduction in urine albumin-to-creatinine ratio

Change from baseline in Kidney Disease Quality of Life-36 (KDQOL-36) score. Scores range from 0 to 100, with higher scores indicating better quality of life.

Change from baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) score. PROMIS includes seven domains: Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, and Pain Interference. Each domain includes 4 items scored from 1 to 5, with raw domain scores ranging from 4 to 20, and domain scores are converted to standardized T-scores with a mean of 50 and standard deviation of 10. A separate Pain Intensity item is rated on a 0 to 10 scale, where 0 indicates no pain and 10 indicates worst imaginable pain. For Physical Function and Ability to Participate in Social Roles and Activities, higher scores indicate better health. For Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference, and Pain Intensity, higher scores indicate greater symptom burden or worse health status.

Change from baseline in Treatment Burden Questionnaire (TBQ) score. TBQ is composed of 13 items rated on a Likert scale ranging from 0 (not a problem) to 10 (big problem) and assesses the burden associated with taking medicine, self-monitoring, laboratory tests, doctor visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. TBQ item scores can be summed into a global score, ranging from 0 to 130. Higher scores indicating greater treatment burden.

Change from baseline in Living with Medicines Questionnaire version 3 (LMQ-3) score. LMQ-3 consists of 41 items scored on a 5-point Likert scale. Total scores range from 41 to 205, with higher scores indicating greater treatment burden.