Status:
COMPLETED
Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
Lead Sponsor:
Abbott
Collaborating Sponsors:
Abbott Japan Co.,Ltd
Conditions:
Secondary Hyperparathyroidism
Hemodialysis
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the long-term safety of paricalcitol injection. Subjects will administer clinical supplies 3 times a week, 40 weeks at dialysis session in dose-titration manne...
Detailed Description
The first 12-week period in this study was a dose-response study reported as Study M10-309 (NCT00667576). Only subjects who completed 12 weeks in NCT00667576 were enrolled into this study (M10-312). B...
Eligibility Criteria
Inclusion
- Patients who completed 12 weeks of Study M10-309 (NCT00667576).
Exclusion
- Patients taking drugs that affect intact parathyroid hormone (iPTH), calcium, or bone metabolism.
- Patients with progressive malignancy or clinically significant hepatic disease.
- Patients who developed severe cerebrovascular/cardiovascular disease during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
- Patients with uncontrolled diabetes during the dose-response portion of the study (i.e., during M10-309, NCT00667576).
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT00701805
Start Date
July 1 2008
End Date
December 1 2009
Last Update
April 19 2011
Active Locations (12)
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1
Aichi, Japan
2
Chiba, Japan
3
Fukuoka, Japan
4
Hokkaido, Japan