Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
Recruiting · NCT06398977 · Interventional (participants receive a specific treatment) · Lead sponsor: Sichuan Academy of Medical Sciences
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Patients with PD duration between 1 month and 3 months.
- Patients aged between 18 and 75 years.
- Voluntary signing of informed consent.
- Stable use of a maximum tolerated dose of RAAS inhibitors for one month if hypertension is present.
- Daily urine output ≥ 400ml/day.
- Stable PD prescription for one month.
Exclusion criteria
- Pregnant and lactating women.
- Patients with type 1 diabetes mellitus.
- Patients with type 2 diabetes mellitus who have experienced diabetic ketoacidosis in the past.
- Patients with chronic liver disease, including non-alcoholic fatty liver disease, cirrhosis, ALT \> 120 IU/L, and other clinically confirmed severe liver diseases.
- Patients with more than 2 episodes of urinary tract infection in the past six months.
- Patients with severe allergic reactions (rash or angioedema) to Dapagliflozin.
- Patients using the following medications: rifampicin, phenytoin.
- Patients with malignant tumors.
- Patients who developed peritonitis within one month.
- Patients undergoing combined hemodialysis treatment.
- Patients with a willingness for kidney transplantation within six months.
- Patients with a history of pancreatitis or pancreatic transplantation.
- Patients who experienced acute coronary syndrome or cerebrovascular events within one month.
- Hemoglobin level less than 90g/L.
Where it is running
1 location listed.
- Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita - Chengdu, Sichuan, China