Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder

• The changes of the blood 25(OH)Vitamin D level. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
• The incidence rate of secondary hyperparathyroidism. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  Patients with the blood iPTH level higer than 300 pg/ml will be regard as sHPT.

It is hypothesised that the efficacy and safety of ergocalciferol to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to calcitriol in the patients with CKD stage 3-5.

This study will enroll chronic kidney disease patients, stage 3 to 5, who have chronic kidney disease mineral and bone disease (CKD-MBD)as defined by KDIGO Guidelines. Patients in one center will be randomized to receive oral ergocalciferol or calcitriol. A total of 200 patients will be enrolled, 100 in the ergocalciferol group and 100 in the calcitriol group. Outcomes will be assessed as proportion of patients achieving target blood levels on calcium, phosphorus, parathyroid hormone, and 25 hydroxyvitamin D. Other outcomes will also be assessed, which include secondary hyperparathyroidism, vascular calcification, and cardiovascular diseases.

• Drug: Vitamin D2
  Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
  Other Name: Vit D2
• Drug: 1,25(OH)2 Vitamin D3
  Oral 1,25(OH)2 Vitamin D3 by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
  Other Name: Active Vit D3

• Experimental: Vitamin D2 Treatment
  Intervention: Drug: Vitamin D2
• Active Comparator: 1,25(OH)2 Vitamin D3
  Intervention: Drug: 1,25(OH)2 Vitamin D3

Inclusion Criteria:

• Patients with age between 18-75 years.
• Patients with chronic kidney disease stage 3 to 5, and concurrent chronic kidney disease mineral and bone disorder.

Exclusion Criteria:

• Renal artery stenosis, inherent renal malformation, solitary kidney, or malignancy in urinary system.
• New fracture in last 3 months.
• Active system immunity diseases.
• History of liver failure
• History of intestinal malabsorption or chronic diarrhea
• Treatment with phenobarbital, phenytoin, rifampicin, sucralfate, steroids, digoxin, or other medications that could affect vitamin D metabolism
• Primary hyperparathyroidism
• Treatment with cinacalcet or other calcimimetic within the past 6 months
• Anticipated dialysis within 6 months after randomization
• Have an unstable medical condition, defined as having been hospitalized within 30 days before screening, the expectation of recurrent hospital admissions or life expectancy of less than 6 months in the judgment of the investigator
• Subject is currently enrolled in, or fewer than 30 days have passed since subject has completed another investigational device or drug study(s); or subject is receiving another investigational agent(s).
• Current treatment with vitamin D 50,000 IU
• Using glucocorticoid or immunosuppressive agents.
• Acute renal dysfunction.
• The expected live time is less than 2 years.
• Pregnant or lactating woman.
• Suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
• Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.