Clinical Trials Logo

Clinical Trial Summary

Sodium-glucose co-transporter 2 inhibitors (Sglt2i) attenuate the incidence of cardiovascular events in individuals with preserved or mildly reduced kidney function. Whether this benefit is also observed among individuals with end-stage renal disease (ESRD), in whom cardiovascular disease is a leading cause of mortality, remains unexplored. To appraise the influence of dialysis on the pharmacokinetics of Sglt2i is a prerequisite to determining the treatment regimen that best fits this population. In this study ESRD individuals, aged 18 years and older, on a regular dialysis regimen for a minimum of 3 months at the Nephrology Division of the Clinics Hospital of the University of Campinas (Unicamp) will be enrolled in a pharmacokinetics study. In the single-dose protocol, hemodialysis participants will take Dapagliflozin 10mg P.O. immediately before the dialysis session, and blood samples will be collected every 30min during dialysis and again 24h and 48h after termination. The dialysate will be continuously sampled in a tank and aliquots collected for further analysis. In the multiple-dose protocol, both hemodialysis and peritoneal dialysis participants will take Dapagliflozin 10mg P.O. daily in the morning for 7 days. Blood samples will be collected at baseline, and again after 48h and 7 days. The plasma levels of dapagliflozin and its inactive metabolite, D3OG, will be calculated from blood and dialysate samples using liquid chromatography mass spectrometry. The primary outcome is the plasma concentration-time curve of dapagliflozin and its inactive metabolite D3OG during a regular hemodialysis session. Secondary outcomes are: (i) the steady-state plasma concentration of Dapa; (ii) the accumulation ratio of Dapa; (iii) the total mass of Dapa and D3OG extracted by the dialysate; (iv) the dialytic clearance of dapagliflozin.


Clinical Trial Description

n/a


Study Design


Related Conditions & MeSH terms


NCT number NCT05343078
Study type Interventional
Source University of Campinas, Brazil
Contact
Status Completed
Phase Phase 4
Start date April 25, 2022
Completion date October 1, 2022

See also
  Status Clinical Trial Phase
Completed NCT04087213 - Study of HemoCareā„¢ Hemodialysis System for Home Nocturnal Dialysis in Patients With ESRD N/A
Completed NCT02207088 - Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin in HCV Genotype 1-Infected Adults With Chronic Kidney Disease Phase 3
Not yet recruiting NCT03090828 - Economic Evaluation of an Education Platform for Patients With End-stage Renal Disease N/A
Completed NCT02237521 - The Effect of the Incretin Hormones on the Endocrine Pancreatic Function During Hyperglycemia in End-stage Renal Disease N/A
Withdrawn NCT01691196 - Inflammation in Peritoneal Dialysis Patients: Effect of Obesity
Completed NCT01394341 - Liraglutide Treatment to Patients With Severe Renal Insufficiency Phase 4
Active, not recruiting NCT00247507 - The Effects of Acetylcysteine on Alleviating Damage of Oxidative Stress in Hemodialysis Patients Phase 4
Completed NCT00307463 - Effects of Strict Volume Control in Hypertensive Hemodialysis Patients on Cardiac Structure and Chronic Inflammation Phase 4
Recruiting NCT00155363 - Effect of Different Hemodialysis Modality on Adiponectin,Vascular Function and Clinical Prognosis Phase 4
Completed NCT00234156 - The Effect of Fructose on Blood Fats in Dialysis Patients and Healthy Volunteers N/A
Completed NCT00586131 - Arterial pH and Total Body Nitrogen Balances in APD Phase 4
Active, not recruiting NCT05027074 - Global Study of MK-2060 (Anti-Factor XI Monoclonal Antibody) in Participants With End Stage Renal Disease Receiving Hemodialysis (FXI Hemodialysis Study) (MK-2060-007) Phase 2
Recruiting NCT04575077 - The Role of Hepcidin as a Biomarker to Predict Successful Renal Transplantation
Enrolling by invitation NCT05001009 - Goals of Care Conversations Study N/A
Completed NCT01756508 - Eculizumab for Prevention and Treatment of Kidney Graft Reperfusion Injury Phase 2
Recruiting NCT03862859 - The Danish Warfarin-Dialysis Study - Safety and Efficacy of Warfarin in Patients With Atrial Fibrillation on Dialysis Phase 4
Terminated NCT03661229 - Cardiovascular and Respiratory Assessment Using Biometric Signals in a Non-contact Monitoring Device N/A
Completed NCT03288922 - Protein-bound Toxin Removal Between Limited Blood Flow Super High-flux Online HDF and High-Efficiency Online HDF N/A
Completed NCT02360748 - A Plant Based High Protein Diet to Improve Nutritional Outcomes in Peritoneal Dialysis Patients N/A
Completed NCT02572882 - Gut Microbiome and p-Inulin in Hemodialysis N/A