Dapagliflozin helps preserve kidney 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
This study is testing if the drug dapagliflozin can help protect kidney function and improve heart health in people who are starting peritoneal dialysis.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sichuan Academy of Medical Sciences Academic / other |
| Locations | 1 site (Chengdu, Sichuan) |
| Trial ID | NCT06398977 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of dapagliflozin on preserving residual renal function (RRF) in patients undergoing peritoneal dialysis (PD). It aims to determine whether this sodium-glucose co-transporter-2 (SGLT2) inhibitor can protect RRF and improve cardiac health over a 24-week treatment period. The study will enroll patients with a PD duration of 1 to 3 months and will monitor various health parameters to assess the drug's efficacy. The research is motivated by previous findings that SGLT2 inhibitors may reduce renal injury and improve outcomes in chronic kidney disease patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with a PD duration of 1 to 3 months and stable urine output.
Not a fit: Patients with type 1 diabetes, severe liver disease, or those who have had recent urinary tract infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve kidney function and overall health outcomes for patients on peritoneal dialysis.
How similar studies have performed: While SGLT2 inhibitors have shown promise in non-dialysis chronic kidney disease patients, this specific application in peritoneal dialysis is novel and untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Chengdu, Sichuan
- Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita — Chengdu, Sichuan, China (Recruiting)
Study contacts
- Principal investigator: Jin Chen, MD — Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospital
- Study coordinator: Jin Chen, MD
- Email: jessicakxcj@uestc.edu.cn
- Phone: 0086-28-87393195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.