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

Launched by IAIN BRESSENDORFF · May 31, 2023

Keywords

ClinConnect Summary

Diabetic kidney disease (DKD) is the leading cause of end-stage kidney disease (ESKD) worldwide and declining kidney function is associated with a graded increase in the risk of death or hospitalization. Thus, prevention of kidney disease progression is of vital importance to prevent excess morbidity and mortality among people with DKD.

Increasing levels of albuminuria in patients with DKD are associated with a graded increase in the risk of developing ESKD and among patients with nephrotic-range albuminuria (i.e. \> 2.000 mg/day) progressive decline in kidney function is particularly rapi...

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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