Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - A Pilot Study

Herlev and Gentofte Hospital0 个研究点目标入组 20 人开始时间: 2021年5月17日最近更新: 2022年3月2日

适应症

试验速览

暂无简介。

•Age = 18 years
•Diagnosis of diabetes mellitus type 2
•Biopsy-proven diabetic nephropathy
•UACR = 2,000 mg/g
•UACR = 1,500 mg/g if treated with sodium-glucose cotransporter 2 inhibitor (SGLT2i)
•Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m2
•Negative pregnancy test and use of safe contraception (birth control pills, birth control implant, birth control transdermal patch, birth control vaginal ring, or birth control contraceptive injection) for women of a childbearing age.
•Able to give informed consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 20
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Kidney transplant recipient.
•Findings on kidney biopsy suggestive of other or concomitant glomerulonephritis, e.g. focal segmental glomerulosclerosis, membranous nephropathy, immunoglobulin A nephropathy, minimal change disease, membranoproliferative nephropathy, pauci-immune vasculitis (findings associated with hypertensive nephropathy are not exclusion criteria).
•Plasma potassium at baseline > 5.2 mmol/L.
•Active malignancy (basal or squamous cell skin carcinoma, localised prostate cancer, and cancer with no signs of reoccurrence after 5 years are exempt from this).
•Systolic heart failure with NYHA class III-IV.
•Liver failure classified as Child-Pugh C.
•Primary hyperaldosteronism.
•Previous cerebral or retinal haemorrhage.
•Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial.
•Participation in other interventional trials.
•Allergy towards one of more of the drugs to be used during the trial.

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