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Brief Title: Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)
Official Title: Phase II Study of Paricalcitol Injection Extension Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Study ID: NCT00701805
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 manner, following 12 weeks of treatment in the dose-response study, M10-309 (NCT00667576).
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). Baseline in this study was the same as Baseline in NCT00667576. The duration of treatment in Study M10-312 was 40 weeks (for a total of 52 weeks, including NCT00667576).
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
, Aichi, , Japan
, Chiba, , Japan
, Fukuoka, , Japan
, Hokkaido, , Japan
, Ibaragi, , Japan
, Kanagawa, , Japan
, Kumamoto, , Japan
, Nagano, , Japan
, Nagasaki, , Japan
, Osaka, , Japan
, Saitama, , Japan
, Tokyo, , Japan
Name: Moriaki KUBO
Affiliation: Abbott
Role: STUDY_DIRECTOR