Insulin Resistance and Statin Treatment in Renal Transplant Recipients and Patients with Chronic Kidney Disease

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• STUDY 1: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Regular treatment with doses of prednisolone > 5 mg daily; 4) Treatment with prednisolone > 15 mg/day for > 5 days, for any reason within 3 months prior to inclusion; 5) Average change in eGFR of > 5 mL/min estimated over 3 months prior to screening; 6) Blood tacrolimus level continuously outside target range; 7) Known allergy towards study medication; 8) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 9) Prior, severe reaction to or severe side effect from any type of statin; 10) Active or chronic liver disease with serum concentration of ALAT > thrice the upper limit of normal (ULN), or spontaneous INR > 1,5; 11) Pre-existing myositis; 12) Plasma CK concentration > 4 times the ULN; 13) Hereditary galactose intolerance or known glucose/galactose malabsorption; 14) Any other organ transplantation prior to or during the trial; 15) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 16) Inability to understand the spoken and written information given and/or inability to give informed consent; 17) Being under legal guardianship
• STUDY 2: 1) Pre-existing diabetes mellitus; 2) Clinic blood pressure > 160/100 mmHg; 3) Treatment with antidiabetic medication, other than SGLT2-inhibitors for cardio- or renal protective purposes only, and GLP-1 analogs for weight reduction purposes only; 4) Treatment with glucocorticoids or other immunosuppressive medication of any kind; 5) Known allergy towards study medication; 6) Treatment with any type of statin as secondary prophylaxis following a cardiovascular event; 7) Prior, severe reaction to or severe side effect from any type of statin; 8) Active or chronic liver disease with serum concentration of ALAT > thrice the ULN, or spontaneous INR > 1,5; 9) Pre-existing myositis from any cause; 10) Plasma CK concentration > 4 times the ULN; 11) Hereditary galactose intolerance or known glucose/galactose malabsorption; 12) Any organ transplantation prior to or during the trial; 13) Pregnancy or breastfeeding or unable or unwilling to use secure contraception to avoid pregnancy (female participants only); 14) Inability to understand the spoken and written information given and/or inability to give informed consent; 15) Being under legal guardianship