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Maintenance Vitamin D Therapy for Secondary Hyperparathyroidism (2HPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Masataka Adachi, Kumamoto University
ClinicalTrials.gov Identifier:
NCT00828347
First received: January 22, 2009
Last updated: December 16, 2015
Last verified: December 2015
Results First Received: July 5, 2011  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Secondary Hyperparathyroidism
Interventions: Drug: 1.0 μg/day Alfacalcidol
Drug: 0.25 μg/day Alfacalcidol

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
High Dose Alfacalcidol 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.
Low Dose Alfacalcidol 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.

Participant Flow:   Overall Study
    High Dose Alfacalcidol   Low Dose Alfacalcidol
STARTED   12   11 
COMPLETED   12   11 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
High Dose Alfacalcidol 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.
Low Dose Alfacalcidol 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 Total of all reporting groups

Baseline Measures
   High Dose Alfacalcidol   Low Dose Alfacalcidol   Total 
Overall Participants Analyzed 
[Units: Participants]
 12   11   23 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   11   10   21 
>=65 years   1   1   2 
Age 
[Units: Years]
Mean (Standard Deviation)
 66.3  (9.9)   69.0  (13.7)   67.7  (11.8) 
Gender 
[Units: Participants]
     
Female   3   6   9 
Male   9   5   14 
Region of Enrollment 
[Units: Participants]
     
Japan   12   11   23 


  Outcome Measures

1.  Primary:   Number of Participants With iPTH Levels Maintained at the Target Levels of 60-180 pg/mL iPTH Level   [ Time Frame: Participants were followed for 24 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Sample size was small, so it will be necessary to conduct further studies in a larger number of patients.


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
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
e-mail: m-adachi@gpo.kumamoto-u.ac.jp



Responsible Party: Masataka Adachi, Kumamoto University
ClinicalTrials.gov Identifier: NCT00828347     History of Changes
Other Study ID Numbers: KumaNeph2
Study First Received: January 22, 2009
Results First Received: July 5, 2011
Last Updated: December 16, 2015
Health Authority: Japan: Ministry of Health, Labor and Welfare