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

• Status: Completed
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dongliang Zhang, MD
• Collaborator: Beijing Municipal Science & Technology Commission
• Treatments: Calcitriol; Cholecalciferol; Ergocalciferols; Vitamin D; Vitamins

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.