Long-term Safety Study of Paricalcitol Injection in Chronic Kidney Disease Patients With Hemodialysis (HD)

• Status: Completed
• Trial end date: 2009-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Abbott
• Collaborator: Abbott Japan Co.,Ltd
• Treatments: Ergocalciferols

Criteria

Inclusion Criteria:

• Patients who completed 12 weeks of Study M10-309 (NCT00667576).

Exclusion Criteria:

• 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).