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

Hemodialysis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00701805
• Other study ID #: M10-312
• Status: Completed
• Phase: Phase 2
• First received: June 17, 2008
• Last updated: March 18, 2011
• Start date: July 2008
• Est. completion date: December 2009

Study information

• Verified date: March 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Kidney Diseases
• Neoplasm Metastasis
• Renal Insufficiency, Chronic
• Secondary Hyperparathyroidism

Intervention

Drug:
• Paricalcitol
Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Abbott	Abbott Japan Co.,Ltd

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants With of Hypercalcemia	The percentage of participants with an event of hypercalcemia, defined as at least 1 adjusted calcium > 11.5 mg/dL or at least 2 consecutive adjusted calcium >= 11.0 mg/dL during the 52 weeks of the study.	Anytime during the study through Week 53	Yes
Primary	The Percentage of Participants With Hyperphosphatemia	The percentage of participants with an event of hyperphosphatemia, defined as at least 2 consecutive phosphorus >= 7.0 mg/dL during the 52 weeks of the study.	Anytime during the study through Week 53	Yes
Secondary	The Mean Change in Intact Parathyroid Hormone (iPTH)		From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)	No
Secondary	The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit		From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)	No
Secondary	The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%		Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)	No
Secondary	Change in Mean iPTH		Every week from Baseline through Week 13 and every other week thereafter until Week 53	No
Secondary	Duration of 2 Consecutive Decreases in iPTH >= 50%		From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)	No
Secondary	Duration of 2 Consecutive iPTH Values <= 180 pg/mL		From Baseline to the participant's Final Visit (which could occur anytime between study initiation to Week 53)	No
Secondary	The Percentage of Participants Whose Abnormal Baseline Alkaline Phosphatase Was Normalized at Final Visit		From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)	No
Secondary	The Percentage of Participants Whose Abnormal Baseline Bone Specific Alkaline Phosphatase (BSAP) Was Normalized at Final Visit		From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)	No

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