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

• 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: Indiana University School of Medicine
• Information provided by (Responsible Party): Indiana University ( Indiana University School of Medicine )

Tracking Information

• First Submitted Date: January 31, 2006
• First Posted Date: February 2, 2006
• Results First Submitted Date: March 27, 2012
• Results First Posted Date: May 2, 2016
• Last Update Posted Date: May 2, 2016
• Study Start Date: January 2006
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: January 31, 2006): percent reduction in PTH

Current Secondary Outcome Measures (submitted: April 18, 2016)

Systolic Blood Pressure at 3 Months [ Time Frame: 3 month ]

systolic blood pressure at 3 months

• Original Secondary Outcome Measures (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: Cholecalciferol Versus Doxercalciferol in the Treatment of Secondary Hyperparathyroidism in Chronic Kidney Disease
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Renal Osteodystrophy

Intervention

• 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

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 18, 2016): 55
• Original Enrollment (submitted: January 31, 2006): 58
• Actual Study Completion Date: December 2009
• Actual Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 82 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00285467
• Other Study ID Numbers: 0508-06
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Indiana University ( Indiana University School of Medicine )
• Original Responsible Party: Not Provided
• Current Study Sponsor: Indiana University School of Medicine
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Sharon Moe, MD; Indiana University School of Medicine

• PRS Account: Indiana University
• Verification Date: April 2016