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

Phase 4

Completed

Brief Summary: It is hypothesised that the efficacy and safety of Vitamin D2 soft capsule to treat the Chronic Kidney Disease Mineral and Bone Disease (CKD-MBD) are equal to 1,25(OH)2 Vitamin D3 (Rocaltrol) in the patients with CKD stage 3-5.

Detailed Description: 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 Kidney Disease Improvement Global Outcome (KDIGO) Guidelines. Patients in one center will be randomized to receive oral Vitamin D2 soft capsule or Rocaltrol. A total of 200 patients will be enrolled, 100 in the Vitamin D2 group and 100 in the 1,25(OH)2 Vitamin D3 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 (sHPT), vascular calcification, and cardiovascular diseases.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
1,25(OH)2 Vitamin D3	1,25(OH)2 Vit D3	Patients will be treated by 1,25(OH)2 Vitamin D3. Oral 1,25(OH)2 Vitamin D3(Rocaltrol) 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.
Vitamin D2 Treatment	Vitamin D2	Patients will be treated by 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.

Primary Outcome Measures

Name	Time	Method
The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.	24 months	The blood levels of intact parathyroid hormone (iPTH) at the 24th month of following up will be detected.
The Blood Levels of Calcium at the 24th Month of Following up.	24 months	The blood levels of calcium at the 24th month of following up will be detected.
The Blood Levels of Phosphorus at the 24th Month of Following up.	24 months	The blood levels of phosphorus at the 24th month of following up will be detected.

Secondary Outcome Measures

Name	Time	Method
The Blood 25(OH)Vitamin D Level.	24 months	The levels of blood 25(OH)Vitamin D at the 24th month of following up.
The Incidence Rate of Secondary Hyperparathyroidism.	24 months	Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT. The incidence of sHPT during following up were recorded and compared between two groups.