Evaluating the short-term renal and systemic effects of Dapagliflozin in non-diabetic patients with stage IV CKD at risk of ESKD because of severe renal insufficiency and persistent proteinuria: A prospective, randomized, double-blind, placebo-controlled, cross-over study - Dapagliflozin in non-diabetic stage IV CKD

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI0 sites32 target enrollmentJune 8, 2021

DrugsFORXIGA - 10 MG - COMPRESSE RIVESTITE CON FILM- USO ORALE - BLISTER CALENDARIZZATO (ALU/ALU) - 28 COMPRESSE

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI
Enrollment: 32
Status: Active, not recruiting
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 8, 2021

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

IRCCS- ISTITUTO DI RICERCHE FARMACOLOGICHE MARIO NEGRI

Eligibility Criteria

Inclusion Criteria

•1Provision of informed consent prior to any study specific procedures
•2Male or female more than 18 year old
•3Non\-diabetic Stage\-IV CKD
•4Fasting blood glucose \= 125 mg (\= 6\.9 mmol/l) and HbA1C \=6\.4% (\= 47 mmol/mol)58 without treatment with oral blood glucose lowering medications and/or insulin
•5Two\-hour plasma glucose \<200 mg/dl during 75\-g oral glucose tolerance test (OGTT)58
•6Persistent proteinuria (24\-hour urinary protein excretion \= 0\.5 grams in at least two consecutive evaluations \>1 week apart) despite RAS inhibitor therapy with ACE inhibitors and/or ARBs (or without RAS inhibitors in patients with specific contraindications to these medications)
•7eGFR 15 to 30 ml/min/1\.73 m2 by CKD\-Epi equation
•8Blood pressure \<150/90 mmHg without changes in blood pressure lowering medications over the last four weeks before the randomization
•9Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
•10Female subjects must be 1 year post\-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of dapagliflozin\\placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long\-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.

Exclusion Criteria

•1Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
•2Participation in another clinical study with an investigational product during the last month
•3Ischemic kidney disease (because of possible excess risk of acute kidney injury upon SGLT2\-inhibitor associated reduction in sodium pool and kidney perfusion pressure)
•4Rapidly progressive kidney disease (e GFR reduction \= 30% over the last three months) and expected risk of progression to end stage kidney failure and need of renal replacement therapy by dialysis or transplantation during the study period.
•5Active systemic autoimmune diseases;
•6Concomitant treatment with steroids or any other immunosuppressive agent
•7Hypersensitivity to the active principle (dapagliflozin) or any of the excipients (e.g. lactose);
•8Severe/unstable heart failure with or without decreased systolic function requiring hospitalization or changes in pharmacological therapy over the last three months
•9Uncontrolled hypertension (BP \>150/90 mmHg despite optimized pharmacological treatment and diet or symptomatic hypotension
•10Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening