Clinical Drug Experience Knowledgebase

Criteria

Inclusion criteria for the intervention trial

Age ≥ 40 and ≤ 75 years
T2D (World Health Organization criteria)
eGFR ≥ 30ml/min/1,73m2 at screening
Persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months)
LDL > 1.5mmol/L at screening
Ability to communicate with the investigator and give informed consent

Exclusion criteria for the intervention trial

Chronic kidney disease primarily ascribed to other causes than diabetes
Acute kidney disease within 3 months
No UACR ≥ 3000mg/g in history
Current or recent (within 3 months) treatment with ezetimibe
Initiation or adjustment in dosage within 1 month of an angiotensin-converting enzyme (ACE) inhibitor, angiotensin II receptor blocker (ARB), glucagon-like peptide-1 receptor (GLP-1RA) agonists, sodium-glucose cotransporter 2 (SGLT-2) inhibitors or anti-dyslipidemia drug, e.g. a statin
Any contraindication to MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination, claustrophobia or body size not compatible with the scanner)
Intolerance to trial drug components
Any previous major organ transplantation
Elective major surgery during the trial
Pregnancy, planned pregnancy or breastfeeding during the trial
Insufficient contraception during the trial in women of childbearing potential
Severe alcohol consumption or abuse of recreational drugs
Moderate to severe liver failure (Child Pugh 7-15)
Any surgical or medical condition which can be expected to significantly alter the absorption of the trial drug (e.g. major gastrointestinal tract surgery or inflammatory bowel disease)
Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the trial
Any reason for suspecting a considerable lack of compliance to the trial

Inclusion criteria for the control group (cross-sectional study alone):

Age ≥ 40 and ≤ 75 years
eGFR ≥60ml/min/1,73m2 at screening
Ability to communicate with the investigator and give informed consent

Exclusion criteria for the control group (cross-sectional study alone):

Any major chronic disease, e.g. diabetes mellitus, chronic kidney disease, ischemic heart disease, chronic obstructive pulmonary disease (this criterium does not include conditions that may be considered risk factors for chronic diseases, e.g. essential hypertension, primary hypercholesterolemia)
Acute kidney disease within 3 months
History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
Current or recent (within 3 months) treatment with ezetimibe
Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
Any previous major organ transplantation
Elective major surgery during the study
Pregnancy, planned pregnancy or breastfeeding during the study
Severe alcohol consumption or abuse of recreational drugs
Moderate to severe liver failure (Child Pugh 7-15)
Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study
Any reason for suspecting a considerable lack of compliance to the study

Inclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):

Age ≥ 40 and ≤ 75 years
T2D (World Health Organization criteria)
eGFR ≥60ml/min/1,73m2 at screening
Ability to communicate with the Investigator and give informed consent

Exclusion criteria for the group of participants with T2D and no DKD (cross-sectional study alone):

Any chronic kidney disease
Acute kidney disease within 3 months
History of persistent UACR ≥ 30mg/g (in more than two out of three valid measurements over a minimum of three months including those at screening) or a previous diagnosis of micro- or macroalbuminuria
Current or recent (within 3 months) treatment with ezetimibe
Any contraindication to an MR-examination (e.g. magnetic foreign body that cannot easily be removed from the body prior to the examination or claustrophobia)
Any previous major organ transplantation
Elective major surgery during the study
Pregnancy, planned pregnancy or breastfeeding during the study
Severe alcohol consumption or abuse of recreational drugs
Moderate to severe liver failure (Child Pugh 7-15)
Recent (within 30 days or 5-half-lives, whichever is longer) or current participation in another clinical study in which an investigational medicinal product or device has been received
Any medical condition or history thereof or any deviation from normal laboratory values that, in the opinion of the investigator, clinically contraindicates or hinders the completion of the study procedures
Any reason for suspecting a considerable lack of compliance to the study