oral paricalcitol in stage 3 - 5 chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to test the hypothesis that selective vitamin d receptor activation reduces left ventricular hypertrophy and ameliorates inflammation and atherosclerosis in stage 3 -5 chronic kidney disease.

cardiovascular disease is the leading cause of mortality and morbidity in patients with chronic kidney disease. according to a previous study, only 15.6% of the patients beginning dialysis therapy had a normal echocardiogram, with left ventricular hypertrophy, left ventricular dilatation and systolic dysfunction occurring in 40.7%, 28% and 15.6% of patients, respectively. in addition, these patients are at an accelerated risk of developing atherosclerosis. the kidney disease outcome quality initiative guideline recently raised concerns of a high prevalence of vitamin d deficiency in chronic kidney disease patients not yet requiring dialysis treatment. in addition, very recent data suggested that vitamin d deficiency is an important predictor of mortality in end-stage renal disease patients. furthermore, hemodialysis patients treated with paricalcitol, a selective vitamin d receptor activator, showed a significantly lower risk of cardiovascular death than those not receiving vitamin d therapy. a number of studies also showed positive benefit of vitamin d receptor activator treatment on regression of left ventricular hypertrophy in dialysis patients. however, there is so far no data in patients with stage 3 and 4 chronic kidney disease where a high prevalence of vitamin d deficiency and cardiac hypertrophy has been reported.

Eligibility criteria:
inclusion criteria: * patient with stage 3 -5 chronic kidney disease (that is, egfr \< 60 ml/min per 1.73m2) diagnosed for more than 2 months and not expected to start dialysis within the next 12 months, and * patient with screening echocardiography showing evidence of left ventricular hypertrophy * patient has not received vitamin d therapy in the previous 4 weeks * for entry into the treatment phase, the subject must have: * screening ipth \>= 55 pg/ml or 5.8pmol/l (determined by the nichols second-generation assay or similar assay) * serum calcium \< 10.2 mg/dl (2.55 mmol/l) * serum phosphorus =\< 5.2mg/dl (1.68mmol/l) * ca\*p product \< 54 mg2/dl2 (4.36mmol2/l2) * if female, subject is either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), or is of childbearing potential and practicing birth control measures. * patients who provide informed consent for the study exclusion criteria: * patient with a history of an allergic reaction or significant sensitivity to vitamin d or vitamin d related compounds. * patient with history of renal stones * patient with current malignancy * patients with clinically significant gastrointestinal disease or liver disease * patient with acute renal failure in the recent three months * patient with a history of drug or alcohol abuse within six months prior to the screening phase * patient is known to be human immunodeficiency virus (hiv) positive. * patient with evidence of poor compliance with diet and medication. * patient currently receiving medications that may affect calcium, phosphorus metabolism such as calcitonin, cinacalcet, bisphophonates or vitamin d compounds (other than study drug), or other drugs that may affect calcium or bone metabolism, other than females on stable estrogen and/or progestin therapy. * patients with active granulomatous disease * patient with pregnancy * patients currently receiving glucocorticoid steroid or other immunosuppressive treatment or had been administered glucocorticoid or other immunosuppressive treatment for more than 14 days within recent 6 months. * patients with contraindication for mri examination

Keywords: paricalcitol chronic kidney disease cardiac hypertrophy