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

NCT ID: NCT01633853

Last Updated: 2016-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2015-09-30

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.

Conditions

Vitamin D Deficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vitamin D2 Treatment

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.

Group Type: EXPERIMENTAL

Vitamin D2

Intervention Type: DRUG

Treatment with Vit D2.

1,25(OH)2 Vitamin 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.

Group Type: ACTIVE_COMPARATOR

1,25(OH)2 Vit D3

Intervention Type: DRUG

Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Interventions

Vitamin D2

Treatment with Vit D2.

Intervention Type: DRUG

1,25(OH)2 Vit D3

Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).

Intervention Type: DRUG

Other Intervention Names

Vitamin D2 soft capsules; Rocaltrol

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Municipal Science & Technology Commission

OTHER

Sponsor Role: collaborator

Dongliang Zhang, MD

OTHER

Sponsor Role: lead

Responsible Party

Dongliang Zhang, MD

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dongliang Zhang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Nephrology Department of Beijing Friendship Hospital

Locations

Beijing Friedship Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

Z121107001012138

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2011-2002-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2012-078

Identifier Type: -

Identifier Source: org_study_id