Empagliflozin for Polycystic Kidney Disease
Recruiting in Palo Alto (17 mi)
Overseen byMichel B Chonchol, MD
Age: 18 - 65
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: University of Colorado, Denver
Must not be taking: Loop diuretics, Tolvaptan
Disqualifiers: Diabetes, Hypertension, Heart failure, others
Prior Safety Data
Trial Summary
What is the purpose of this trial?This trial tests empagliflozin, a drug that helps remove excess sugar through urine, in patients with ADPKD who suffer from kidney cysts and eventual kidney failure. The drug may help reduce kidney damage and improve heart health by blocking a protein that reabsorbs sugar. Empagliflozin has been shown to slow the progression of diabetic kidney disease.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications, such as loop diuretics and tolvaptan or other V2 receptor antagonists, before participating.
What data supports the effectiveness of the drug empagliflozin for treating polycystic kidney disease?
Research shows that empagliflozin, a drug used for chronic kidney disease, can slow down the progression of kidney disease and reduce the risk of heart-related deaths. This suggests it might also help with polycystic kidney disease, although specific studies for this condition are needed.
12345Is empagliflozin generally safe for humans?
Empagliflozin, also known as Jardiance, is generally well-tolerated in humans, but it can have side effects and contraindications. It has been studied for safety in people with type 2 diabetes and heart failure, showing it is safe for these conditions, though monitoring for side effects like fluid deficits is recommended.
56789How does the drug empagliflozin differ from other treatments for polycystic kidney disease?
Empagliflozin is unique because it is primarily used to treat type 2 diabetes by preventing glucose reabsorption in the kidneys, which also helps reduce blood pressure and body weight. Its potential use in polycystic kidney disease is novel, as it may help slow kidney disease progression, a benefit observed in chronic kidney disease patients.
15101112Eligibility Criteria
This trial is for adults aged 18-50 with Autosomal Dominant Polycystic Kidney Disease (ADPKD) and moderately reduced kidney function, but not diabetes or heart failure. Participants should have stable kidney health without recent infections and must not be pregnant, using certain diuretics, or have contraindications to MRI scans.Inclusion Criteria
I have been diagnosed with ADPKD according to specific criteria.
My kidney function has been stable for the last 3 months.
You have been categorized as having a specific risk level based on imaging tests done at the Mayo Clinic.
+2 more
Exclusion Criteria
Your blood pressure while sitting is less than 100 mm Hg.
I am currently taking tolvaptan or a similar medication.
Pregnant or lactating
+9 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive empagliflozin or placebo in a 12-month parallel-group, randomized, double-blind, placebo-controlled trial
12 months
Check-in visits every 2 weeks for the 1st month, monthly on month 2 and 3, then every 3 months
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests the safety of Empagliflozin in ADPKD patients over a year. It's a double-blind trial where half the participants will receive Empagliflozin and the other half a placebo, neither group knowing which they're getting to ensure unbiased results.
2Treatment groups
Experimental Treatment
Placebo Group
Group I: ExperimentalExperimental Treatment1 Intervention
Empagliflozin
Group II: Placebo comparatorPlacebo Group1 Intervention
Placebo
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 Coloardo Anschutz Medical CampusAurora, CO
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Who Is Running the Clinical Trial?
University of Colorado, DenverLead Sponsor
University of MarylandCollaborator
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.
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.
Effects of empagliflozin on progression of chronic kidney disease: a prespecified secondary analysis from the empa-kidney trial. [2023]Sodium-glucose co-transporter-2 (SGLT2) inhibitors reduce progression of chronic kidney disease and the risk of cardiovascular morbidity and mortality in a wide range of patients. However, their effects on kidney disease progression in some patients with chronic kidney disease are unclear because few clinical kidney outcomes occurred among such patients in the completed trials. In particular, some guidelines stratify their level of recommendation about who should be treated with SGLT2 inhibitors based on diabetes status and albuminuria. We aimed to assess the effects of empagliflozin on progression of chronic kidney disease both overall and among specific types of participants in the EMPA-KIDNEY trial.
Efficacy and Safety of Dapagliflozin by Baseline Glycemic Status: A Prespecified Analysis From the DAPA-CKD Trial. [2021]The Dapagliflozin and Prevention of Adverse outcomes in Chronic Kidney Disease (DAPA-CKD) study demonstrated risk reduction for kidney and cardiovascular outcomes with dapagliflozin versus placebo in participants with chronic kidney disease (CKD) with and without diabetes. We compared outcomes according to baseline glycemic status.
Pharmacokinetics and bioequivalence of a generic empagliflozin tablet versus a brand-named product and the food effects in healthy Chinese subjects. [2021]Label="OBJECTIVE" NlmCategory="OBJECTIVE">The aim of the present study was to assess the bioequivalence of a generic empagliflozin tablet versus a brand-named empagliflozin tablet (Jardiance®) and evaluate the food effects on the pharmacokinetics (PK) of empagliflozin in healthy Chinese subjects.
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.
Pharmacokinetics, Safety, and Bioequivalence of Two Empagliflozin Formulations after Single Oral Administration under Fasting and Fed Conditions in Healthy Chinese Subjects: An Open-label Randomized Single-dose Two-sequence, Two-treatment, Two-period Crossover Study. [2021]To evaluate the pharmacokinetic properties and safety of empagliflozin, and the bioequivalence of test formulation empagliflozin tablet compared with the brand-name drug Jardiance (reference formulation) after single oral administration under fasting and fed conditions in healthy Chinese subjects.
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.
Pooled Safety and Tolerability Analysis of Empagliflozin in Patients with Type 2 Diabetes Mellitus. [2022]The aim of this analysis was to characterize the safety and tolerability of empagliflozin in patients with type 2 diabetes mellitus (T2DM) who were randomized to empagliflozin (10/25 mg) or placebo in clinical trials.
[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.
[Empagliflozin - the new representative of SGLT2 transporter inhibitors for the treatment of patients with diabetes 2 type]. [2018]Empagliflozin is a new medicine used to reduce hyperglycemia in patients with type 2 diabetes. It belongs to the most advanced class of antidiabetic drugs, known as gliflozins, which prevent reabsorption of glucose through inhibiting SGLT2 sodium-glucose cotransporter. Thereby they cause therapeutic glycosuria, thanks to which a loss of approximately 70 g of glucose per day occurs. This not only effects the decrease in glycemia, but also the loss of body mass, since this excreted glucose cannot be used as an energetic substrate. The studies within phase 3 have proven the therapeutic efficacy of empagliflozin in monotherapy, in combination with the other oral antidiabec drugs and insulin. Another favourable effect of empagliflozin is a slight decrease in blood pressure. In May 2014, empagliflozin was approved for the treatment of patients with type 2 diabetes within the European Union 2014, since October 2014 it has been available in the Czech Republic and since 1 February 2015 empagliflozin (under the trade name Jardiance®) has been partially covered by the health insurance for the treatment of patients with type 2 diabetes either in combination with metformin or in combination with insulin (with or without metformin).
A Case of Severe Metabolic Acidosis due to Jardiance-Induced Euglycemic Diabetic Ketoacidosis. [2021]Metabolic acidosis is frequently encountered in the inpatient setting. It can occur due to either the accumulation of endogenous acids that consumes bicarbonate (high anion gap metabolic acidosis) or loss of bicarbonate from the gastrointestinal tract or the kidney. Jardiance® (empagliflozin) (Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, USA) is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which reduces renal tubular glucose reabsorption, thereby decreasing blood glucose level without stimulating insulin release. This class of drugs is known for reducing cardiovascular events and delay in the progression of chronic kidney disease in patients with type 2 diabetes mellitus (T2DM). However recent data has shown that SGLT2 inhibitors, particularly empagliflozin, carry the risk of inducing euglycemic diabetic ketoacidosis under certain circumstances such as acute illness, and decreased carbohydrate intake, decrease in dose, or discontinuation of insulin. We herein report a 23-year-old female with poorly controlled diabetes mellitus on empagliflozin, who presented with dyspnea and coronavirus disease SARS-CoV-2 (COVID-19) infection and found to have severe unexplained euglycemic metabolic acidosis, with elevated urine ketones.