Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - A Pilot Study (WP3)
Diabetic Kidney Disease
About this trial
This is an interventional treatment trial for Diabetic Kidney Disease
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years Diagnosis of diabetes mellitus type 2 (American Diabetes Association / European Association for the Study of Diabetes (ADA/EASD) definition)10 Biopsy-proven diabetic nephropathy UACR ≥ 2,000 mg/g or 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 highly effective and safe contraception Able to give informed consent. Exclusion Criteria: Kidney transplant recipient Findings on kidney biopsy suggestive of other or concomitant glomerulonephritis (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. Biliary obstructive disorders. Acute myocardial infarction within the last three months. Severe cardiac arrhythmias. Clinically active gout. Plasma sodium at baseline < 135 mmol/L. Other diseases or conditions, which, in the opinion of the site investigator, would prevent participation in or completion of the trial. Treatment with potent CYP3A4 inhibitors. Participation in other interventional trials. Allergy towards one of more of the drugs to be used during the trial
Sites / Locations
- Department of Nephrology, Herlev and Gentofte HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
Standard of Care
Albuminuria-reduction protocol
Maximally tolerated dose of ACEi or ARB (but not both), SGLT2i, and finerenone. Blood pressure target <130/80 mm Hg
Maximally tolerated dose of ACEi or ARB (but not both), SGLT2i, and finerenone. Thereafter addition of semaglutide, pentoxifylline, hydrochlorothiazide, and baricitinib. Blood pressure target <130/80 mm Hg, but if still UACR >300 further reduction in blood pressure will be attempted as tolerated.