Hemodialysis Clinical Trial
Official title:
Safety, Tolerability, and Feasibility of Empagliflozin Therapy in Dialysis-dependent ESKD
The purpose of this study is to find out if empagliflozin, a new diabetic medication that has been shown to be very effective in lowering the risk of heart failure, is safe and tolerated in dialysis patients. In the recent years, empagliflozin has become a major tool to prevent heart failure hospitalization and to reduce the risk for cardiovascular death in diabetic and non-diabetic patients. Although patients with severe chronic kidney disease and ESKD have very high risk of heart failure and cardiovascular death, they have been excluded from all of the previous studies. If this medication is found to be well tolerated and safe in dialysis patients through this study, future clinical studies can evaluate if this medication can also reduce the risk of heart failure and cardiovascular death in dialysis patients.
Patients on dialysis have a very high risk of heart failure and heart-related death compared to people who do not require dialysis. While treatment options for heart failure have improved over the years for those without kidney disease, there has been very limited discoveries to improve survival for dialysis patients. Empagliflozin, a new diabetic medication that works by making the kidney put out more sugar in the urine, has recently shown to have significant efficacy to protect the kidney and to reduce heart failure hospitalization and cardiovascular death in both diabetic and non-diabetic patients. Studies suggest that this medication may have benefits on the heart, fat cells, blood vessels, and possibly other organ systems. The benefit remains consistent whether you have diabetes or not. Empagliflozin is now approved by the U.S. Food and Drug Administration (FDA) to treat not only diabetes but also chronic kidney disease and to reduce the risk of cardiovascular death and hospitalization for heart failure in adults regardless of the diabetes status. The clinical studies, however, have excluded those with severe kidney disease and those requiring dialysis. The safety of empagliflozin in the dialysis patients has not been established, and thus it is not available for people with end-stage kidney disease. If empagliflozin is safe in dialysis patients, it may potentially become a very powerful tool to lower the risk of heart-related complications and prolong survival. Although empagliflozin is approved by the FDA to treat patients with chronic kidney disease, heart failure, and/or diabetes, our study will evaluate empagliflozin as an investigational drug to assess if it is safe in patients receiving chronic dialysis. If we can establish safety, the next step would be to conduct a larger clinical study to evaluate its ability to lower heart failure and death risk in dialysis patients. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04892745 -
Impact of Hemodialysis on Cutaneo-muscular Electrical Impedance
|
||
Not yet recruiting |
NCT04925674 -
Study of HEC53856 in Patients With Subjects With End-Stage Renal Disease Receiving Dialysis.
|
Phase 1 | |
Active, not recruiting |
NCT03183245 -
Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis
|
Phase 3 | |
Completed |
NCT03365635 -
Administration of Zepatier (Grazoprevir Plus Elbasvir) in Chronic Hemodialysis (HD) Patients With Hepatitis C
|
Phase 4 | |
Withdrawn |
NCT02904343 -
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study
|
N/A | |
Withdrawn |
NCT01855334 -
L-Arginine and Spironolactone Trial in Dialysis-Dependent ESRD
|
Phase 4 | |
Completed |
NCT01700465 -
Estimating and Predicting Hemodynamic Changes During Hemodialysis
|
N/A | |
Recruiting |
NCT01195519 -
The Assessment of Quality of Life in Patients With Peritoneal Dialysis and Hemodialysis
|
N/A | |
Completed |
NCT00737672 -
GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis
|
Phase 3 | |
Completed |
NCT00527774 -
Effect of HCV Infection on Insulin Resistance and Malnutrition-inflammation Complex Syndrome in Regular Hemodialysis Patients
|
N/A | |
Completed |
NCT00942253 -
Exercise Training in Dialysis Patients With Restless Legs Syndrome (RLS)
|
Phase 2 | |
Completed |
NCT00850252 -
Use of a Lifeline Graft in the A-V Shunt Model
|
Phase 1/Phase 2 | |
Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
Completed |
NCT00776750 -
Influenza Vaccination in Hemodialysis Patients and Renal Transplant Recipients
|
Phase 4 | |
Recruiting |
NCT06351007 -
Educational Program on Dietary Adherence and Nutritional Knowledge in Chronic Kidney Disease Patients (EPAK)
|
N/A | |
Withdrawn |
NCT03664141 -
Impact of Cannabis Oil on Nutrition in Hemodialysis Patients Study (ICON-HP Study)
|
Phase 3 | |
Completed |
NCT03909698 -
Antibiotic Dosing in Patients on Intermittent Hemodialysis
|
||
Recruiting |
NCT03311321 -
Vitamin K to Slow Progression of Cardiovascular Disease Risk in Hemodialysis Patients
|
N/A | |
Recruiting |
NCT06098924 -
HD Patients' Depression and Happiness
|
||
Recruiting |
NCT03419923 -
Three Anticoagulation Strategies for Hemodialysis in Patients at Risk of Hemorrhage
|
N/A |