Oral Paricalcitol in Stage 3 - 5 Chronic Kidney Disease

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring paricalcitol, chronic kidney disease, cardiac hypertrophy Read More

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