Clinical trial NCT01633853: Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Official title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Vitamin D Deficiency
Keywords: chronic kidney disease mineral and bone disorder
vitamin D2
parathyroid hormone
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: Beijing Municipal Science & Technology Commission
First posted: 2012-07-04
Enrollment: 204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The Blood Levels of Calcium at the 24th Month of Following up.
timeFrame: 24 months
measure: The Blood Levels of Phosphorus at the 24th Month of Following up.
timeFrame: 24 months
measure: The Blood Levels of Intact Parathyroid Hormone at the 24th Month of Following up.
timeFrame: 24 months
Secondary outcomes:
measure: The Blood 25(OH)Vitamin D Level.
timeFrame: 24 months
measure: The Incidence Rate of Secondary Hyperparathyroidism.
timeFrame: 24 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Friedship Hospital
state: Beijing
Study officials:
affiliation: Nephrology Department of Beijing Friendship Hospital
name: Dongliang Zhang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: