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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00828347
Recruitment Status : Completed
First Posted : January 23, 2009
Results First Posted : January 25, 2016
Last Update Posted : January 25, 2016
Sponsor:
Information provided by (Responsible Party):
Masataka Adachi, Kumamoto University

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Secondary Hyperparathyroidism
Interventions Drug: 1.0 μg/day Alfacalcidol
Drug: 0.25 μg/day Alfacalcidol
Enrollment 35
Recruitment Details  
Pre-assignment Details  
Arm/Group Title High Dose Alfacalcidol Low Dose Alfacalcidol
Hide Arm/Group Description oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
Period Title: Overall Study
Started 12 11
Completed 12 11
Not Completed 0 0
Arm/Group Title High Dose Alfacalcidol Low Dose Alfacalcidol Total
Hide Arm/Group Description oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. Total of all reporting groups
Overall Number of Baseline Participants 12 11 23
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
11
  91.7%
10
  90.9%
21
  91.3%
>=65 years
1
   8.3%
1
   9.1%
2
   8.7%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 11 participants 23 participants
66.3  (9.9) 69.0  (13.7) 67.7  (11.8)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 11 participants 23 participants
Female
3
  25.0%
6
  54.5%
9
  39.1%
Male
9
  75.0%
5
  45.5%
14
  60.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 12 participants 11 participants 23 participants
12 11 23
1.Primary Outcome
Title Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level
Hide Description [Not Specified]
Time Frame Participants were followed for 24 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title High Dose Alfacalcidol Low Dose Alfacalcidol
Hide Arm/Group Description:
oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
Overall Number of Participants Analyzed 12 11
Measure Type: Number
Unit of Measure: participants
Controlled cases 10 4
Uncontrolled cases 2 7
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Dose Alfacalcidol, Low Dose Alfacalcidol
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.036
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title High Dose Alfacalcidol Low Dose Alfacalcidol
Hide Arm/Group Description oral administration of alfacalcidol at a dose of 1.0 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy. oral administration of alfacalcidol at a dose of 0.25 ug/day in patients whose iPTH level was controlled to < 150 pg/mL by initial maxacalcitol therapy.
All-Cause Mortality
High Dose Alfacalcidol Low Dose Alfacalcidol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
High Dose Alfacalcidol Low Dose Alfacalcidol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
High Dose Alfacalcidol Low Dose Alfacalcidol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/11 (0.00%) 
Sample size was small, so it will be necessary to conduct further studies in a larger number of patients.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: A study of maintenance therapy after intravenous maxacalcitol for secondary hyperparathyroidism
Organization: Department of Nephrology, Kumamoto University Graduate School of Medical Sciences
Phone: +81-96-373-5164
EMail: m-adachi@gpo.kumamoto-u.ac.jp
Layout table for additonal information
Responsible Party: Masataka Adachi, Kumamoto University
ClinicalTrials.gov Identifier: NCT00828347    
Other Study ID Numbers: KumaNeph2
First Submitted: January 22, 2009
First Posted: January 23, 2009
Results First Submitted: July 5, 2011
Results First Posted: January 25, 2016
Last Update Posted: January 25, 2016