Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )
ClinicalTrials.gov Identifier:
NCT00285467
First received: January 31, 2006
Last updated: April 18, 2016
Last verified: April 2016
  Purpose
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.

Condition Intervention
Renal Osteodystrophy
Drug: doxercalciferol
Drug: Cholecalciferol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • Percent Reduction in PTH [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    Percent reduction in PTH from baseline to 3 months


Secondary Outcome Measures:
  • Systolic Blood Pressure at 3 Months [ Time Frame: 3 month ] [ Designated as safety issue: No ]
    systolic blood pressure at 3 months


Enrollment: 55
Study Start Date: January 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Doxercalciferol
doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney.
Drug: doxercalciferol
form of vitamin D that is already in active form.
Other Name: Hectoral
Active Comparator: Cholecalciferol
cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation by cells of the body.
Drug: Cholecalciferol
from of vitamin D that requires cells in the body to make active
Other Name: vitamin D3

Detailed Description:
Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.
  Eligibility

Ages Eligible for Study:   18 Years to 82 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age 18 years old or older, male or female
  • able to sign informed consent
  • CKD stage 3 (GFR 30-59 ml/min) or stage 4 (15-29 ml/min)
  • intact Parathyroid hormone level (iPTH) > 100 pg/ml for stage 3 or iPTH > 150 pg/ml for stage 4
  • calcidiol levels ≤ 20 ng/ml
  • ability to ambulate without assistance

Exclusion Criteria:

  • intact PTH > 400 pg/ml
  • initial corrected Calcium > 9.7 mg/dl
  • initial serum Phosphorous > 5.0 mg/dl
  • initial standardized blood pressure of > 160/100
  • history of significant liver disease or cirrhosis
  • anticipated requirement for dialysis in 6 months
  • malabsorption, severe chronic diarrhea, or ileostomy
  • no calcimimetic or active vitamin D therapy 30 days prior to enrollment
  • use of digoxin, magnesium containing products, mineral oil, or cholestyramine
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00285467

Locations
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Investigators
Study Director: Sharon Moe, MD Indiana University School of Medicine
  More Information

Publications:
Responsible Party: Indiana University School of Medicine
ClinicalTrials.gov Identifier: NCT00285467     History of Changes
Other Study ID Numbers: 0508-06 
Study First Received: January 31, 2006
Results First Received: March 27, 2012
Last Updated: April 18, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Indiana University:
kidney, parathyroid hormone, vitamin d

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Secondary
Renal Osteodystrophy
Parathyroid Diseases
Endocrine System Diseases
Rickets
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Kidney Diseases
Urologic Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Vitamin D Deficiency
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders
Vitamins
Vitamin D
Ergocalciferols
Cholecalciferol
1 alpha-hydroxyergocalciferol
Micronutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on July 28, 2016