Chronic Kidney Disease MedDRA version: 21.1 Level: LLT Classification code 10009119 Term: Chronic renal failure System Organ Class: 100000004857
Conditions
Interventions
Trade Name: FORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 30X1 COMPRESSA (DOSE UNITARIA)
Product Name: Forxiga
Product Code: [na]
Pharmaceutical Form:
Sponsors
UNIVERSITY MEDICAL CENTER GRONINGEN
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: eGFR > 30 and =65 years) yes F.1.3.1 Number of subjects for this age range 26
Exclusion criteria
Exclusion criteria: Diagnosis of type 1 diabetes mellitus Urinary protein excretion > 3500 mg/24 hour Autosomal dominant polycystic kidney disease or autosomal recessive polycystic kidney disease, lupus nephritis, or ANCA-associated vasculitis Indication for immunosuppressants as per the treating physician’s judgment. Receiving cytotoxic therapy, immunosuppressive therapy, or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment. Active malignancy aside from treated squamous cell or basal cell carcinoma of the skin. Diabetes type 2 patients with recent (last 6 months) of hyperosmolar hyperglicemic state who are prone to development redistributive hyperkalemia (movement of potassium out of the cells) Pregnant women and women of child-bearing potential who are not using reliable contraception Cardiovascular disease: myocardial infarction, angina pectoris, percutanous transluminal coronary angioplasty, coronary artery bypass grafting, stroke, heart failure (NYHA I-IV) 160 / 100 mmHg) History of autonomic dysfunction (e.g. history of fainting or clinically significant orthostatic hypotension) History of amputations eGFR change > 30% in the last six months before study randomization Current therapy with renin inhibitor or MRA Concomitant treatment with ACEi and ARB Intolerance or contraindications to drugs inhibiting the Renin-Angiotensin-Aldosterone System (RAAS). Cyclosporine A, tacrolimus, trimethoprim due to increased risk of hyperkalemia in combination with eplerenone. Ketoconazole, itraconazole, ritonavir, nelfinavir, clarithromycin, telithromycin and nefazadone, lithium, amiodarone, diltiazem, verapamil due to increase in toxicity when combined with eplerenone. Rifampicin, carbamazepine, phenytoin, phenobarbital due the risk of decreased eplerenone efficacy. Participation in any clinical investigation within 3 months prior to initial dosing or longer if required by local regulations, and for any other limitation of participation based on local regulations. Donation or loss of 400 ml or more of blood within 8 weeks prior to initial dosing History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during the screening. Any medication, surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine the correlation between individual albuminuria lowering responses of the MRA eplerenone, SGLT2 inhibitor dapagliflozin and their combination in patients with chronic kidney disease ;Secondary Objective: To determine the correlation between office/home blood pressure-lowering responses of eplerenone, dapaglifozin and their combination. To determine which patients characteristics predict the albuminuria and blood pressure response to eplerenone, dapagliflozin and their combination;Primary end point(s): Correlation between individual albuminuria response between eplerenone and dapagliflozin.;Timepoint(s) of evaluation of this end point: 24 weeks which corresponds to the sum of the three treatment periods plus the three wash-out periods | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): the degree of correlation in either office or home blood pressure-lowering responses with eplerenone and dapagliflozin ; Correlation between selected biomarkers of interest at baseline such as NT-proBNP and change in albuminuria from baseline during interventions;Timepoint(s) of evaluation of this end point: 24 weeks which corresponds to the sum of the three treatment periods plus the three wash-out periods; 24 weeks which corresponds to the sum of the three treatment periods plus the three wash-out periods | — |
Countries
Italy, Netherlands, Spain
Contacts
Public ContactStruttura Complessa Nefrologia e Di
AOU "Luigi Vanvitelli"
Outcome results
None listed