RecruitingNot ApplicableNCT06398977
Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Single-Center Randomized Open-Label Study
Sponsor
Sichuan Academy of Medical Sciences
Enrollment
70 participants
Start Date
Mar 11, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
This study aims to explore the role of dagliflozin in preserving the residual renal function(RRF) in peritoneal dialysis (PD) patients.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria6
- 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 Criteria14
- 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.
Interventions
DRUGDapagliflozin
Dapagliflozin10MG, PO once daily
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06398977