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

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ClinicalTrials.gov Identifier: NCT00285467
Recruitment Status : Completed
First Posted : February 2, 2006
Results First Posted : May 2, 2016
Last Update Posted : May 2, 2016
Sponsor:
Information provided by (Responsible Party):
Indiana University ( Indiana University School of Medicine )

Tracking Information
First Submitted Date  ICMJE January 31, 2006
First Posted Date  ICMJE February 2, 2006
Results First Submitted Date  ICMJE March 27, 2012
Results First Posted Date  ICMJE May 2, 2016
Last Update Posted Date May 2, 2016
Study Start Date  ICMJE January 2006
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Percent Reduction in PTH [ Time Frame: 3 month ]
Percent reduction in PTH from baseline to 3 months
Original Primary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
Percent Reduction in PTH
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
Systolic Blood Pressure at 3 Months [ Time Frame: 3 month ]
systolic blood pressure at 3 months
Original Secondary Outcome Measures  ICMJE
 (submitted: January 31, 2006)
effect on blood pressure, pain and general well being
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
Official Title  ICMJE Comparison of Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in CKD
Brief Summary 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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Renal Osteodystrophy
Intervention  ICMJE
  • Drug: doxercalciferol
    form of vitamin D that is already in active form.
    Other Name: Hectoral
  • Drug: Cholecalciferol
    from of vitamin D that requires cells in the body to make active
    Other Name: vitamin D3
Study Arms  ICMJE
  • 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.
    Intervention: Drug: doxercalciferol
  • 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.
    Intervention: Drug: Cholecalciferol
Publications * Moe SM, Saifullah A, LaClair RE, Usman SA, Yu Z. A randomized trial of cholecalciferol versus doxercalciferol for lowering parathyroid hormone in chronic kidney disease. Clin J Am Soc Nephrol. 2010 Feb;5(2):299-306. doi: 10.2215/CJN.07131009. Epub 2010 Jan 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 18, 2016)
55
Original Enrollment  ICMJE
 (submitted: January 31, 2006)
58
Actual Study Completion Date  ICMJE December 2009
Actual Primary Completion Date December 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 82 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00285467
Other Study ID Numbers  ICMJE 0508-06
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Indiana University ( Indiana University School of Medicine )
Study Sponsor  ICMJE Indiana University School of Medicine
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Sharon Moe, MD Indiana University School of Medicine
PRS Account Indiana University
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP