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

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this trial is to investigate the feasibility and safety of implementing a protocol-based treatment aggressively targeting albuminuria in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria. If this approach is feasible, the results of the trial will inform the design of a large-scale randomized clinical trial to evaluate the effect of this treatment on hard kidney endpoints (initiation of dialysis, kidney transplantation, and death from kidney failure) in subjects with biopsy-proven diabetic nephropathy and severely elevated albuminuria.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iain Bressendorff
• Treatments: Pentoxifylline

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