Diabetic Kidney Disease MedDRA version: 21.1 Level: LLT Classification code 10012687 Term: Diabetic renal disease System Organ Class: 100000004857
Conditions
Sponsors
Herlev and Gentofte Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age = 18 years • Diagnosis of diabetes mellitus type 2 • 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 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
Exclusion criteria
Exclusion criteria: • 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether addition of various different drugs which all reduce albuminuria in addition to standard treatment can reduce albuminuria to a greater degree than standard treatment alone in persons with biopsy-proven diabetic kidney disease.;Secondary Objective: To investigate whether addition of various different drugs which all reduce albuminuria in addition to standard treatment is safe and feasible in persons with biopsy-proven diabetic kidney disease.;Primary end point(s): • Number of subjects achieving a 50% reduction in UACR at week 36.;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Number of subjects achieving a 70% reduction in UACR at week 36. • Number of subjects achieving UACR 5.5 mmol/L. • Incidence of potassium > 6.0 mmol/L. • Incidence of symptomatic hypotension.;Timepoint(s) of evaluation of this end point: 36 weeks | — |
Countries
Denmark
Contacts
Public ContactDepartment of Nephrology
Herlev and Gentofte Hospital
Outcome results
None listed