Empagliflozin for Dialysis Patients with Kidney Failure
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: University of Utah
Approved in 4 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for this trial?
The protocol does not specify if you need to stop taking your current medications. However, it does not mention any specific requirements to stop or continue existing medications.
What data supports the idea that Empagliflozin for Dialysis Patients with Kidney Failure is an effective drug?
The available research shows that empagliflozin, while primarily studied for heart failure and diabetes, has shown benefits in patients with chronic kidney disease (CKD). Specifically, the EMPA-KIDNEY trial found that empagliflozin reduced the progression of kidney disease or the risk of cardiovascular death over two years. This suggests that empagliflozin could be effective for patients with kidney failure, even though the direct evidence for dialysis patients is not detailed in the provided information.
12345What safety data exists for empagliflozin in dialysis patients with kidney failure?
Empagliflozin, also known as Jardiance, has been studied for safety in patients with type 2 diabetes and chronic kidney disease (CKD) in placebo-controlled clinical trials. It is approved for reducing cardiovascular death and hospitalization in heart failure patients, even without diabetes. While generally well-tolerated, it has side effects and contraindications, particularly fluid deficits, which should be monitored. The EMPA-KIDNEY trial is investigating its effects on renal and cardiovascular disease in CKD patients.
12367Is the drug Empagliflozin a promising treatment for dialysis patients with kidney failure?
Yes, Empagliflozin is a promising drug for dialysis patients with kidney failure. It helps protect the heart and kidneys, reduces the risk of heart failure, and slows down kidney disease progression. It is also effective in managing diabetes and can lower blood pressure and body weight.
12348Eligibility Criteria
This trial is for adults with severe chronic kidney disease (ESKD) who have been on dialysis for at least 3 months, regardless of whether they have diabetes. It's not open to those with active cancer treatment, unhealed skin ulcers on the lower body, allergies to empagliflozin, pregnancy, type 1 diabetes, current IV antibiotic therapy for infections, a history of Fournier's gangrene or recent severe hypoglycemia.Inclusion Criteria
I have been on dialysis for 3 months or more.
Exclusion Criteria
I am currently receiving treatment for cancer.
I have an open sore on my leg that hasn't healed.
I am currently receiving IV antibiotics for an infection.
I have Type 1 diabetes.
I have had Fournier's gangrene before.
I have had diabetic ketoacidosis.
Participant Groups
The study tests if empagliflozin is safe and can be tolerated by patients dependent on dialysis due to ESKD. Empagliflozin has helped prevent heart failure in diabetic and non-diabetic patients but hasn't been studied in those with advanced kidney disease undergoing dialysis.
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Empagliflozin 25mgExperimental Treatment1 Intervention
Empagliflozin 25 mg oral: Those randomized to 25 mg daily dose will be treated with 10 mg QD for the first 2 weeks before escalating the dose to 25 mg QD in week 3, based on tolerability. At the end of the dose-escalation phase (weeks 3-4), participants will continue the randomized assignment for additional 8 weeks (weeks 5-12, treatment phase), for a total of 12 weeks.
Group II: Empagliflozin 10mgExperimental Treatment1 Intervention
Empagliflozin10mg oral: Those randomized to 10 mg daily dose will be treated with 10 mg QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
Group III: PlaceboPlacebo Group1 Intervention
Encapsulated placebo with an identical appearance to empagliflozin: Those randomized to placebo will be treated with an oral placebo QD throughout the dose escalation and the treatment phase for a total of 12 weeks.
Empagliflozin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇺🇸 Approved in United States as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
- Cardiovascular risk reduction
🇨🇦 Approved in Canada as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
- Chronic kidney disease
🇯🇵 Approved in Japan as Jardiance for:
- Type 2 diabetes mellitus
- Heart failure with reduced ejection fraction
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of UtahSalt Lake City, UT
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Who is running the clinical trial?
University of UtahLead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Collaborator
References
In CKD, once-daily empagliflozin reduced progression of kidney disease or CV death at 2 y. [2023]Label="SOURCE CITATION">EMPA-KIDNEY Collaborative Group; Herrington WG, Staplin N, Wanner C, et al. Empagliflozin in patients with chronic kidney disease. N Engl J Med. 2023;388:117-27. 36331190.
Diabetes Drug Now Approved for Heart Failure. [2023]The diabetes drug empagliflozin (Jardiance) is now approved to reduce the risk of cardiovascular death and hospitalization in adults with heart failure, even if they do not have diabetes.Nurses and NPs should monitor patients for adverse effects, especially fluid deficits.
The dual role of empagliflozin: Cardio renal protection in T2DM patients. [2022]Empagliflozin (Jardiance®) is an insulin independent antihyperglycemic agent used in treatment of T2D.The drug is a sodium glucose cotransporter-2 (SGLT2) inhibitor approved in USA and Europe and other countries of the world. As empagliflozin demonstrates cardioprotective and Reno protective properties its prime target are patients having CVD and CKD complicated by T2D. This review sheds light on mechanism of action of the drug and with the help of clinical outcomes establishes the use of empagliflozin in T2D patients. Although empagliflozin is a well-tolerated and easy to administer drug, it has some side effects and contraindications which are discussed in the article to help the reader weigh its beneficial effects against its adverse effect and understand its use in clinical medicine.
Drug treatment with empagliflozin lowered risk for hospitalization in people with heart failure with reduced ejection fraction: plain language summary of the EMPEROR-Reduced study. [2023]Label="WHAT IS THIS SUMMARY ABOUT?" NlmCategory="UNASSIGNED">This is a summary of the article describing the EMPEROR-Reduced study of empagliflozin, which was published in the New England Journal of Medicine. Empagliflozin (brand name Jardiance®) is a new drug therapy for the treatment of chronic heart failure. Chronic heart failure is a long-term condition where the heart cannot pump enough blood around the body, leading to symptoms such as shortness of breath, fatigue and build-up of too much water in the body (fluid retention). It also increases the risk for premature death.
Empagliflozin in Patients with Chronic Kidney Disease. [2023]The effects of empagliflozin in patients with chronic kidney disease who are at risk for disease progression are not well understood. The EMPA-KIDNEY trial was designed to assess the effects of treatment with empagliflozin in a broad range of such patients.
Safety of Empagliflozin in Patients With Type 2 Diabetes and Chronic Kidney Disease: Pooled Analysis of Placebo-Controlled Clinical Trials. [2022]To assess the safety of empagliflozin in patients with type 2 diabetes and moderate to severe chronic kidney disease (CKD) (category G3-4) enrolled in clinical trials.
Design, recruitment, and baseline characteristics of the EMPA-KIDNEY trial. [2023]The effects of the sodium-glucose co-transporter 2 inhibitor empagliflozin on renal and cardiovascular disease have not been tested in a dedicated population of people with chronic kidney disease (CKD).
[EMPAGLIFLOZIN (JARDIANCE) :Nw SGLT2 COTRANSPORTER INHIBITOR FOR TREATING TYPE 2 DIABETES]. [2022]Empagliflozin is a new inhibitor of sodiumglucose cotransporters type 2 (SGLT2) for the treatment of type 2 diabetes mellitus (T2DM). Its specific action inhibits glucose reabsorption in renal tubules and thus promotes glucosuria. This effect results in a reduction in fasting and postprandial glycaemia and a decrease of glycated haemoglobin (HbA(Ic)), independently of insulin. Furthermore, calorie urinary loss promotes weight reduction and osmotic diuresis lowers arterial blood pressure. The efficacy of empagliflozin increases according to the level of hyperglycaemia but decreases in patients with renal insufficiency. In 24 to 104-week controlled trials versus placebo, empagliflozin reduces HbA(1c) (approximately 0.8%), without hypoglycaemia (except in patients already treated with insulin or sulphonylureas). This improvement in glucose control is rather similar to that observed with active comparators (metformin, glimepiride or sitagliptin), with the advantage for empagliflozin of reducing body weight (approximately 2 kg) and blood pressure (systolic approximately 4 mm Hg and diastolic approximately 2 mm Hg). Empagliflozin has shown a cardiovascular protection in the EMPA-REG OUTCOME trial. Mycotic genital infections occur more frequently, especially in women, while a negligible increase in mild urinary tract infections may be observed. The risk of hypotension and volume depletion is low, although it should be carefully checked in more fragile and at risk patients. Empagliflozin (Jardiance), which is commercialized at the doses of 10 mg and 25 mg once daily, is indicated for the treatment of T2DM and reimbursed in Belgium with conditions as add-on to a background glucose-lowering therapy.