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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Beijing Municipal Science & Technology Commission
Information provided by (Responsible Party):
Dongliang Zhang, MD, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01633853
First received: June 29, 2012
Last updated: October 19, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Vitamin D Deficiency
 Drug: Vitamin D2
Drug: 1,25(OH)2 Vitamin D3
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study of Vitamin D2 Virus 1,25(OH)2-Vitamin D3 in the Treatment of Chronic Kidney Disease Mineral and Bone Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • The changes on the blood levels of calcium, phosphorus, and intact parathyroid (iPTH) hormone during 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    The blood levels of calcium, phosphorus,and intact parathyroid (iPTH) will be detected every three months. The values during follow-up will be compared to the baseline.


Secondary Outcome Measures:
  • The changes of the blood 25(OH)Vitamin D level. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • The incidence rate of secondary hyperparathyroidism. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Patients with the blood iPTH level higher than 300 pg/ml will be regard as sHPT.


Estimated Enrollment: 200
Study Start Date: July 2012
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vitamin D2 Treatment Drug: 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.
Other Name: Vit D2
Active Comparator: 1,25(OH)2 Vitamin D3 Drug: 1,25(OH)2 Vitamin D3
Oral 1,25(OH)2 Vitamin D3 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.
Other Name: Active Vit D3

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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01633853

Locations
China, Beijing
Beijing Friedship Hospital
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Dongliang Zhang, MD
Beijing Municipal Science & Technology Commission
Investigators
Principal Investigator: Dongliang Zhang, Doctor Nephrology Department of Beijing Friendship Hospital
  More Information

No publications provided

Responsible Party: Dongliang Zhang, MD, Associate Professor, Capital Medical University
ClinicalTrials.gov Identifier: NCT01633853     History of Changes
Other Study ID Numbers: 2012-078, Z121107001012138, 2011-2002-02
Study First Received: June 29, 2012
Last Updated: October 19, 2012
Health Authority: China: Beijing Municipal Science and Technology Commission

Keywords provided by Capital Medical University:
chronic kidney disease mineral and bone disorder
vitamin D2
parathyroid hormone

Additional relevant MeSH terms:
Bone Diseases
Kidney Diseases
Vitamin D Deficiency
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Musculoskeletal Diseases
Urologic Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
 Renal Insufficiency
Cholecalciferol
Vitamin D
Ergocalciferols
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on May 19, 2013