Empagliflozin on Residual Kidney Function in Incident Peritoneal Dialysis Patients
NCT Number: NCT06483074
Acronym: EMPIRIC-PD
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: End Stage Renal Disease on Dialysis|Peritoneal Dialysis Complication|Sodium-glucose Cotransporter-2 Inhibitor|Residual Kidney Function
Interventions: DRUG: Empagliflozin 10 MG
Sponsor: Chinese University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-07-29
Completion Date: 2026-10-31
Locations: Chinese University of Hong Kong, Hong Kong, Hong Kong

Summary:
Empagliflozin, a new class of diabetes medication, has demonstrated a reduction in renal function decline among patients with chronic kidney disease, regardless of their diabetes status. However, all previous studies excluded dialysis patients. Patients starting dialysis may still produce a certain amount of urine. Importantly, patients with better preserved residual kidney function tend to have better control of blood pressure and volume status, improved nutrition status, higher quality of life and reduced mortality rate.

The purpose of this study is to learn about the safety of empagliflozin in patients on peritoneal dialysis, in preparation for a future large clinical trial. Participants who newly initiate peritoneal dialysis will be randomly allocated to either empagliflozin on top of standard of care, or standard of care alone. Over a follow-up period of six months, the investigators will collect information on urine volume, blood pressure and glucose control. Safety, tolerability and drug compliance of empagliflozin will also be evaluated. If empagliflozin is found to be safe and well tolerated in patients on peritoneal dialysis, further large-scale randomized controlled trial may be conducted to evaluate its impact on residual kidney function and other relevant clinical outcomes.

Primary Outcome Measures: Recruitment rate, Number of patients who are randomized each month following the run-in period, During randomization|Medication adherence, Proportion of prescribed empagliflozin that are taken by the patients (pill counting will be done by investigators at each follow up), 6 months|Retention rate, Proportion of patients who have completed the whole study among patients that are randomized, 6 months
Secondary Outcome Measures: Slope of residual GFR, Residual GFR is calculated as the arithmetic mean of 24-hour urinary urea and creatinine clearances, 6 months|Time to anuria, Anuria is defined as urine volume \<100ml per day, 6 months|Difference in residual urine volume, Residual urine volume is measured by 24-hour urine collection, Month 0, 2, 4, 6|Difference in volume of overhydration, Volume of overhydration is measured by a validated multi-frequency bioimpedance spectroscopy, Month 0, 2, 4, 6|Difference in plasma N-terminal pro-brain type natriuretic peptide, Indicator for left ventricular dysfunction, Month 0, 2, 4, 6|Difference in systolic blood pressure, Office blood pressure will be measured according to standardized protocol. The average of three consecutive measurements by an automated device will be recorded., Month 0, 2, 4, 6|Difference in volume of ultrafiltration per day, The volume of fluid removed from patient by peritoneal dialysis each day, Month 0, 1, 2, 4, 6|Incidence of urinary tract infection, Proportion of patients who have symptoms consistent with urinary tract infection and organisms identified by urine culture, 6 months|Incidence of genital tract infection, Proportion of patients who are symptomatic and require antibiotic or anti-fungal treatment, 6 months|Incidence of ketoacidosis, Proportion of patients who have serum pH \<7.3 and elevated serum beta hydroxybutyrate ≥3.0 mmol/L, 6 months|Incidence of lower limb amputation, Proportion of patients who require lower limb amputation by operation that is not secondary to trauma, 6 months|Incidence of severe hypoglycemia, Proportion of patients who have hypoglycemia requiring third party assistance, 6 months
Other Outcome Measures: Change in peritoneal solute transfer rate, This is measured by dialysate-to-plasma creatinine ratio in a standard peritoneal equilibration test (PET), Month 0, 6|Difference in frailty status by Clinical Frailty Scale, Clinical Frailty Scale is 9-point scale which is used to quantify the frailty and functional status of dialysis patients. A higher score indicates greater degree of frailty., Month 0, 6|Difference in frailty status by Fried frailty phenotype, Fried phenotype consists of five criteria which include both patient-reported domains and objective assessments. Subjects are considered to be frail if they meet three or more criteria., Month 0, 6