Male and female, non-diabetic patients aged =18 with moderate proteinuria (baseline urinary protein/creatinine ratio =500 mg/g and =5000 mg/g), hypercholesterolaemia (fasting LDL-C =90 mg/dL (2.33 mmol/L) and receiving current treatment with ACE (Angiotensin converting enzyme) inhibitors and/or ARBs (Angiotensin receptor blockers) for =3 months prior to Visit 1.
Conditions
Interventions
Trade Name: Crestor 5mg
Product Name: Crestor 5mg encapsulated tablet
Product Code: AZD4522
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: rosuvastatin
Other descriptive name: AZD4522
Co
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study lead-in period at Visit 1, patients must fulfill all of the following criteria: 1. Provision of written informed consent 2. Male or female aged =18 3. Fasting LDL-C levels collected at Visit 1: =90 mg/dL (2.33 mmol/L) if patient has not taken statin therapy within 2 weeks of Visit 1 =60 mg/dL (1.55 mmol/L) if patient has taken statin therapy within 2 weeks of Visit 1 4. Proteinuria as evidenced by one or more of the following criteria at Visit 1: a. Urinary dipstick for protein = 1+ (clinic and/or central laboratory), or b. One or more of the following documented =3 months prior to Visit 1: •Urinary protein to creatinine ratio =500 mg/gm to =5000 mg/gm •24-hour urinary protein excretion =500 mg to =5000 mg •Urinary albumin to creatinine ratio =350 mg/gm to =3500 mg/gm •24-hour urinary albumin excretion =350 mg to =3500 mg 5. Stable and individually optimized treatment with ACE inhibitor and/or an ARB for =3 months prior to Visit 1 -- See protocol for continuation in the lead-in period after Visit 1 and for inclusion into the randomised treatment period. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. History of statin intolerance, statin-induced myopathy, or serious hypersensitivity reaction to other HMG-CoA reductase inhibitor (statin) 2. Previous rosuvastatin use 1.5 times ULN at Visit 1 10. Type I or II diabetes 11. History of homozygous familial hypercholesterolaemia or known Type III hyperlipoproteinemia (familial dysbetalipoproteinemia) 12. History of alcohol or drug abuse, or both in the last 5 years 13. Current active liver disease as defined by elevations of >2 x ULN in ALT at Visits 1 or 3 or severe hepatic impairment 14. Unexplained creatine kinase (CK) > 2 x ULN at Visits 1 and 3 15. Participation in another investigational drug study <4 weeks before Visit 1 or in accordance with local ethics if a longer period is stipulated. Patients who withdrew from the treatment phase of this or a previous rosuvastatin study cannot re-enter this study 16. Serious or unstable medical or psychological conditions that, in the opinion of the investigator, would compromise the patient’s safety or successful participation in the study 17. Patients whose hormone replacement therapy (HRT) or oral contraceptive therapy (OCT) was initiated or changed within the 3 months prior to Visit 1 18. Use of oral or intravenous immunosuppressive medications =3 months prior to Visit 1 19. Severe renal impairment, as judged by estimated GFR (MDRD equation) <40 ml/min/1.73m2 at Visit 3 20. Any known clinical condition that, in the opinion of the investigator, would require an adjustment of the ACE inhibitor and/or ARBs after Visit 1 21. Statin therapy after Visit 1. Patients may be either statin naïve or have undergone statin withdrawal at Visit 1 22. Underlying renal disease attributed to autosomal dominant polycystic kidney disease, primary idiopathic intersitial nephritis, HIV (human immunodeficiency virus) nephropathy or ischemic renal disease due to bilateral renal artery stenosis or unilateral renal artery stenosis in a single kidney 23. Asian ethnicity 24. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio from baseline to Week 52 in non-diabetic patients with moderate proteinuria and hypercholesterolaemia.;Secondary Objective: 1. to evaluate the effects of rosuvastatin and atorvastatin on urinary protein excretion by evaluation of the change in urinary protein/creatinine ratio 2. to evaluate the effects of rosuvastatin and atorvastatin on urinary albumin excretion by evaluation of the change in urinary albumin/creatinine ratio 3. to evaluate the effects of rosuvastatin and atorvastatin on: low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), nonHDL-C, apolipoprotein A1 (ApoA-1), apolipoprotein B (ApoB), TC/HDL-C, LDL-C/HDL-C, nonHDL-C/HDL-C and ApoB/ApoA-1) to explore the relationship between renal effects and lipid changes 4. to evaluate the effects of rosuvastatin and atorvastatin on renal function by evaluation of the change in estimated glomerular filtration rate (GFR) predicted from the Modification of Diet in Renal Disease (MDRD) [Levey et al 1999] equation;Primary end point(s): The primary outcome variable (end point) is the change in urinary protein/creatinine ratio from baseline to Week 52. | — |
Countries
Denmark, Germany, Hungary, Italy
Outcome results
None listed