Feasibility of Aggressive Albuminuria Reduction in Biopsy-Proven Diabetic Nephropathy - a Pilot Study
- Status
- TerminatedStopped: Slow recruitment
Results none - Why it is watched
- non-weight indication: kidney
- Who it enrolls
- age 18 Years to no upper limit; no BMI minimum stated; conditions: Diabetic Kidney Disease
- Interventions
- ACEi / ARB, SGLT2i, finerenone, semaglutide, pentoxifylline, hydrochlorthiazide, baricitinib
- Conditions
- Diabetic Kidney Disease
- Phase and size
- Phase 2 · 1 participants
- Dates
- Start 2023-08-01
Primary completion 2024-09-23 - Sponsor
- Iain Bressendorff (Other)
- Last checked
- Sep 13, 2026
01Endpoints
What the trial will measure
- urine albumin/creatinin-ratio (UACR) reduction to less than 50% of baselineafter 9 months of treatment
02Eligibility
Who can take part
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
03Change log
Registry changes
No changes recorded since the trial was added.