Efficacy of Vitamin D2 to Treat Chronic Kidney Disease Mineral and Bone Disorder
Information source: Capital Medical University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Vitamin D Deficiency
Intervention: Vitamin D2 (Drug); 1,25(OH)2 Vitamin D3 (Drug)
Phase: Phase 4
Status: Enrolling by invitation
Sponsored by: Dongliang Zhang, MD Official(s) and/or principal investigator(s): Dongliang Zhang, Doctor, Principal Investigator, Affiliation: Nephrology Department of Beijing Friendship Hospital
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 24 months.
Secondary outcome: The changes of the blood 25(OH)Vitamin D level.The incidence rate of secondary hyperparathyroidism.
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
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 (sHPT), vascular calcification, and cardiovascular diseases.
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
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.
Locations and Contacts
Beijing Friedship Hospital, Beijing, Beijing 100050, China
Additional Information
Starting date: July 2012
Last updated: December 2, 2014
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