A Prospective, multicenter, randomized, non-inferior study to evaluate the effect of Remogliflozin 100 mg vs Dapagliflozin 10 mg in addition to standard of care, in patients of Type 2 Diabetes Mellitus (T2DM) with Chronic Kidney Disease (REMO- CKD) - Remo-CKD

Prof Dr Hemant Gupta0 个研究点目标入组 0 人开始时间: 待定最近更新: 2023年5月29日

试验速览

暂无简介。

•1) Adults (more than or equal to 18 years) of either gender diagnosed with Type-2 Diabetes Mellitus more than 6 months back
•2) Having uncontrolled glycaemia (HbA1c more than 7.0 percent & Less than 9.0 percent) with no change in anti-diabetic treatment therapy since last 8 weeks
•3) On stable therapy (more than 6weeks prior to screening) of metformin monotherapy or dual therapy of metformin plus other OHA
•4) Patients who are on following concomitant background medications for CKD management: ACEi and ARB if not medically contraindicated -With comorbid chronic kidney disease diagnosed at least 3 months prior to screening
•5) Patients with eGFR more than or equal to 25 ml per min per 1.73m2 to Less than or equal to 60 ml per min per 1.73m2 at time of initiation of treatment
•6) Evidence of increased albuminuria 3 months or more and UACR more than or equal to 200 and less than or equal to 5000 mg per g at visit 1
•7) Patients requiring treatment with SGLT2i for T2DM management as part of routine clinical practice
•8) Patients who understand & willing to comply with study requirements and provide written informed consent for participation

•1) Female patients who are pregnant or breast feeding
•2) Patients with known liver or kidney dysfunction (eGFR less than 25 ml per min per 1.73m2) at time of initiation of treatment.
•3) Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis
•4) Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment.
•5) History of organ transplantation
•6) Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor
•7) New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment
•8) MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

发起方

Prof Dr Hemant Gupta