Feasibility of aggressively lowering urine albumin in individuals with kidney biopsy-proven diabetic kidney disease - A Pilot Study
- Conditions
- Diabetic Kidney DiseaseMedDRA version: 21.1Level: LLTClassification code 10012687Term: Diabetic renal diseaseSystem Organ Class: 100000004857Therapeutic area: Diseases [C] - Hormonal diseases [C19]
- Registration Number
- EUCTR2021-001661-21-DK
- Lead Sponsor
- Herlev and Gentofte Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 20
•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
•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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Secondary end point(s): •Number of subjects achieving a 70% reduction in UACR at week 36.<br>•Number of subjects achieving UACR <300 mg/g at week 36.<br>•Between-groups difference in UACR at week 36.<br>•Between-groups difference in UACR at week 40.<br>•Between-groups difference in eGFR at week 36.<br>•Between-groups difference in eGFR at week 40.<br>•Between-groups difference in systolic and diastolic blood pressure at week 36.<br>•Between-groups difference in systolic and diastolic blood pressure at week 40.<br>•Between-groups difference in plasma potassium at week 36.<br>•Within-group changes in blood levels of creatinine, potassium, urate, haematocrit, ionised calcium, intact parathyroid hormone, phosphate, and magnesium.<br>•Incidence of adverse and serious adverse events.<br>•Incidence of potassium > 5.5 mmol/L.<br>•Incidence of potassium > 6.0 mmol/L.<br>•Incidence of symptomatic hypotension.;Timepoint(s) of evaluation of this end point: 36 weeks