Full loss of residual renal function causes higher mortality in dialysis patients; findings from a marginal structural model.
Willem M van der Wal, Marlies Noordzij, Friedo W Dekker...
https://pubmed.ncbi.nlm.nih.gov/21317411Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID06398977
Dapagliflozin Delays the Loss of Residual Renal Function in Patients Undergoing Peritoneal Dialysis: A Randomized Open-Label Study
Led by Sichuan Academy of Medical Sciences · Updated on 2024-05-03
70
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to study the effects of dapagliflozin on preserving residual renal function (RRF) in patients undergoing peritoneal dialysis (PD). Residual renal function helps remove water and waste from the body, supports hormone secretion, and maintains internal balance. Current methods to protect RRF in PD patients have limited impact, and while dapagliflozin, an SGLT2 inhibitor, is used for diabetes and has shown kidney protection in non-dialysis patients, its role in PD patients is not yet known. Participants are randomly assigned to one of two groups for 24 weeks: one group receives dapagliflozin 10 mg orally once daily along with standard treatments such as peritoneal dialysis and medications for blood pressure and blood sugar control; the other group receives only the standard treatments without dapagliflozin. This study is designed to explore dapagliflozin's potential benefits on kidney function and heart health in these patients. During the study, researchers will measure changes in urine volume, kidney function, heart markers, blood sugar, sodium levels, blood pressure, body weight, and episodes of peritonitis or hospitalization at various points from baseline up to 24 weeks. They will also monitor levels of dapagliflozin and its metabolites in urine, dialysate, and blood. Participant involvement includes regular tests and assessments to track these health indicators and treatment effects throughout the study period.
CONDITIONS
Brief Title
Dapagliflozin Delays the Loss of Renal Function in Peritoneal Dialysis Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Patients with peritoneal dialysis duration between 1 month and 3 months
- Patients aged between 18 and 75 years
- Voluntary signing of informed consent
- Stable use of maximum tolerated dose of RAAS inhibitors for one month if hypertension is present
- Daily urine output of at least 400 ml
- Stable peritoneal dialysis prescription for one month
You will not qualify if you...
- Pregnant and lactating women
- Patients with type 1 diabetes mellitus
- Patients with type 2 diabetes who have had diabetic ketoacidosis
- Patients with chronic liver disease or severe liver conditions
- Patients with more than 2 urinary tract infections in the past six months
- Patients with severe allergic reactions to dapagliflozin
- Patients using rifampicin or phenytoin
- Patients with malignant tumors
- Patients who developed peritonitis within one month
- Patients undergoing combined hemodialysis
- Patients planning kidney transplantation within six months
- Patients with history of pancreatitis or pancreatic transplantation
- Patients with acute coronary syndrome or stroke within one month
- Hemoglobin level below 90 g/L
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 weeks
Participants receive dapagliflozin 10 mg orally once daily or continue with standard care for 24 weeks while undergoing peritoneal dialysis.
Visits at baseline, Week 2, Week 12, and Week 24
Trial Site Locations
Total: 1 location
1
Sichuan Academy of Medical Sciences and Sichuan Provincial People's Hospita
Chengdu, Sichuan, China, 610000
Actively Recruiting
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Research Team
J
Jin Chen, MD
X
Xinyi Tan, Master
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Relative contribution of residual renal function and peritoneal clearance to adequacy of dialysis: a reanalysis of the CANUSA study.
Joanne M Bargman, Kevin E Thorpe, David N Churchill
https://pubmed.ncbi.nlm.nih.gov/11562415Epidemiology of peritoneal dialysis outcomes.
Aminu K Bello, Ikechi G Okpechi, Mohamed A Osman...
https://pubmed.ncbi.nlm.nih.gov/36114414Empagliflozin and Progression of Kidney Disease in Type 2 Diabetes.
Hans-Henrik Parving, Hiddo Lambers-Heerspink, Dick de Zeeuw
https://pubmed.ncbi.nlm.nih.gov/28106974Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial.
Frederik Persson, Peter Rossing, Priya Vart...
https://pubmed.ncbi.nlm.nih.gov/34183431Comparison of the Effects of Glucagon-Like Peptide Receptor Agonists and Sodium-Glucose Cotransporter 2 Inhibitors for Prevention of Major Adverse Cardiovascular and Renal Outcomes in Type 2 Diabetes Mellitus.
Thomas A Zelniker, Stephen D Wiviott, Itamar Raz...
https://pubmed.ncbi.nlm.nih.gov/30786725Cardiovascular mortality and morbidity in patients with type 2 diabetes following initiation of sodium-glucose co-transporter-2 inhibitors versus other glucose-lowering drugs (CVD-REAL Nordic): a multinational observational analysis.
Kåre I Birkeland, Marit E Jørgensen, Bendix Carstensen...
https://pubmed.ncbi.nlm.nih.gov/28781064Dapagliflozin is associated with lower risk of cardiovascular events and all-cause mortality in people with type 2 diabetes (CVD-REAL Nordic) when compared with dipeptidyl peptidase-4 inhibitor therapy: A multinational observational study.
Frederik Persson, Thomas Nyström, Marit E Jørgensen...
https://pubmed.ncbi.nlm.nih.gov/287719232022 AHA/ACC/HFSA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines.
Paul A Heidenreich, Biykem Bozkurt, David Aguilar...
https://pubmed.ncbi.nlm.nih.gov/35379503A combination of biocompatible peritoneal dialysis solutions and residual renal function, peritoneal transport, and inflammation markers: a randomized clinical trial.
Sing Leung Lui, Susan Yung, Andrew Yim...
https://pubmed.ncbi.nlm.nih.gov/22835900