Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Prospective, Randomized, Multicenter Trial Testing the Antiproteinuric Effect of Statins Added to Combined ACE-inhibitor and Angiotensin Receptor Antagonist Therapy in Proteinuric, Chronic Nephropathies
Brief Summary: End stage renal disease (ESRD) is rapidly growing worldwide. Patients with ESRD have increased morbidity and mortality mostly because of a dramatic excess of cardiovascular disease. Thus, preventing or limiting the progression of chronic nephropathies, in addition to limit the incidence of ESRD, may also postpone death. Drugs that inhibit the renin angiotensin system, such as Angiotensin-Converting-Enzyme inhibitors (ACEi) and Angiotensin II receptor antagonists (ATA), are reno- and cardio-protective in the long-term. There are data that statins,in addition to limit cardiovascular events may have specific reno-protective properties.

Thus we designed a study aimed to evaluate whether statins associated to ACEi and ATA may have an additional reno-protective effect.

ESPLANADE is a multicenter, prospective, randomized, parallel group study in which, after 2 months treatment with ACEi and ATA, two groups of 90 patients, with or without type 2 diabetes, are randomized to 6 months Fluvastatin (40 or 80 mg/day) treatment YES or NO.Twenty Italian Nephrology Units are involved in the trial. The study is fully coordinated by the Clinical Research Center for Rare Disease Aldo e Cele Daccò, Villa Camozzi, Ranica.


Options:
A: Inclusion Criteria:

* Men and women
* minimum 40 years
* Chronic Kidney disease
* Estimated GFR (eGFR) between 30 and 90 ml/min
* Diabetes Mellitus type II

Exclusion Criteria:

* Nephrotic Syndrome
* Anamnestic or clinical signs of significant heart, lung, lever, kidney and brain disease
* Neoplastic disease
* Alcohol abuse,
* Drug abuse
* Pregnancy or nursing
* Blood donation within a month before examination
* Hgb \< 6,0
B: Inclusion Criteria:

* age \>16 years
* hypertension, defined as a systolic or diastolic blood pressure \> 140 or 90 mmHg respectively (or less in patients with concomitant antihypertensive therapy)
* creatinine clearance \>20 ml/min/1.73m2 (with variation of less than 30% in the 3 months prior to study entry)
* urinary protein excretion rate persistently \> 1 g/24 hours (average of at least two measurements in two urine collections two weeks apart) without evidence of urinary tract infection or overt heart failure (New York Heart Association class III or more)
* written informed consent

Exclusion criteria:

* specific contraindication to statin therapy because of a previous coronary event or serum LDL-cholesterol levels \> 190 mg/dL despite a low cholesterol (\<200 mg/day) diet and a saturated fatty acid in take less than 7% of total calories will not be included
* chronic treatment with corticosteroids, nonsteroidal anti-inflammatory drugs, or immunosuppressive drugs
* acute myocardial infarction or cerebrovascular accident in the six months preceding the study - severe uncontrolled hypertension (diastolic blood pressure \>115 and/or systolic blood pressure \>220 mmHg)
* evidence or suspicion of renovascular disease, obstructive uropathy, type 1 diabetes mellitus, vasculitides, cancer
* elevated serum aminotransferase concentrations - chronic cough
* history of poor tolerance or allergy to ACEi, ATA or statins
* drug or alcohol abuse
* pregnancy, breast feeding and ineffective contraception
* legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequences of the trial.
C: Inclusion Criteria:

* Individuals between 18 and 85 years of age
* Individuals with any psychiatric disorder who are taking lithium

  o Patients will be recruited from the Douglas Mental Health University Institute, Jewish General Hospital and McGill University Health Centre.
* Able and willing to give informed consent.
* Chronic and current lithium users (at least 2 months of Lithium use).
* Stable dose of lithium for the past 2 months.
* Patients taking any lithium level will be included.
* Patients with any psychiatric diagnosis will also be included.
* NDI defined as a 10-hour water restriction UOsm \<600mOsm/Kg.

Exclusion Criteria:

* Patients allergic to Statins
* Patients with statin use within 6 weeks prior to the study
* Patients with a past history of severe adverse reaction to statins.
* Patients with a baseline Low Density Lipoprotein (LDL) level \<1.5.
* Relative contraindications to statin use 42: pregnancy or lactation, concurrent use of fibrates, heavy ethanol consumption (\>50 units/week).
* Incapacity to consent
* Deemed by the treating physician to have a severe cognitive or behavioural disturbance such as acute delirium or moderate-severe DSM5 Neurocognitive Disorder (dementia), preventing their ability to complete safely the study questionnaire and/or to provide blood and urine test.
D: Inclusion Criteria:

* hyperlipidemia
* urinary protein
* diabetes

Exclusion Criteria:

* previous rosuvastatin treatment \< 6 months prior to Visit 1
* statin intolerance
* severe hypertension

Answer: B