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 )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Treatment
• Condition: Renal Osteodystrophy
• Interventions: Drug: doxercalciferol; Drug: Cholecalciferol
• Enrollment: 55

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
Arm/Group Description	Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Period Title: Overall Study
Started	25	22
Completed	25	22
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D	Total
Arm/Group Description		Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.	Total of all reporting groups
Overall Number of Baseline Participants		25	22	47
Baseline Analysis Population Description		47 subjects had at least one follow up visit after taking medications and were included in results.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	22 participants	47 participants
		65 (10)	62 (10)	63.5 (10)
Sex: Female, Male [1]; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	22 participants	47 participants
	Female	9 36.0%	12 54.5%	21 44.7%
	Male	16 64.0%	10 45.5%	26 55.3%
		[1] Measure Description: 55 subjects were consents and underwent qualifying blood tests. 47 subjects were randomized to treatment: 25 to doxercalciferol and 22 to cholecalciferol.
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	25 participants	22 participants	47 participants
		25	22	47

Outcome Measures

1. Primary Outcome

Title	Percent Reduction in PTH
Description	Percent reduction in PTH from baseline to 3 months
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

The initial sample size was based on the published response to doxercalciferol versus placebo where a 46% reduction in PTH was observed over 6 months, with a 51% SD. The expected reduction in PTH with cholecalciferol was based on the best-case scenario decrease of 17.8% in PTH with ergocalciferol from our own clinic setting.

Arm/Group Title	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
Arm/Group Description:	Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Overall Number of Participants Analyzed	25	22
Mean (Standard Deviation); Unit of Measure: % change in PTH baseline to 3 months
	27 (34)	10 (31)

2. Secondary Outcome

Title	Systolic Blood Pressure at 3 Months
Description	systolic blood pressure at 3 months
Time Frame	3 month

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
Arm/Group Description:	Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
Overall Number of Participants Analyzed	25	22
Mean (Standard Deviation); Unit of Measure: mmHg
	120 (47)	128 (33)

Adverse Events

Time Frame	4 months
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
Arm/Group Description	Doxercalciferol is an active Vitamin D readily usable by human body.	Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
All-Cause Mortality
	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)
Total	--/--	--/--
Serious Adverse Events
	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/25 (0.00%)	0/22 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Doxercalciferol, Active Vitamin D	Cholecalciferol, Inactive Vitamin D
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/25 (0.00%)	0/22 (0.00%)

Limitations and Caveats

Larger, long term studies are needed to demonstrate efficacy of mineral-related and non-mineral-related endpoints and safety.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Sharon Moe, MD
• Organization: Indiana University School of Medicine
• Phone: 317-278-2868
• EMail: smoe@iupui.edu

Publications of Results:

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.

• Responsible Party: Indiana University ( Indiana University School of Medicine )
• ClinicalTrials.gov Identifier: NCT00285467
• Other Study ID Numbers: 0508-06
• First Submitted: January 31, 2006
• First Posted: February 2, 2006
• Results First Submitted: March 27, 2012
• Results First Posted: May 2, 2016
• Last Update Posted: May 2, 2016