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

Abbott107 enrolled

Overview

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).

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).

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

107

Conditions

Secondary Hyperparathyroidism Hemodialysis

Interventions

ParicalcitolDRUG

Intravenous (IV) paricalcitol, 3 times weekly, immediately before completion of hemodialysis.

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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).

Locations (12)

Unnamed facility

Aichi, Japan

Unnamed facility

Chiba, Japan

Unnamed facility

Fukuoka, Japan

Unnamed facility

Hokkaido, Japan

Outcomes

Primary Outcomes

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.

Time frame: Anytime during the study through Week 53

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.

Time frame: Anytime during the study through Week 53

Secondary Outcomes

The Mean Change in Intact Parathyroid Hormone (iPTH)

Time frame: From Baseline to Final Visit (which could occur anytime between study initiation and Week 53)

The Percentage of Participants With iPTH <= 180 pg/mL or >= 50% Decrease of iPTH at the Participant's Final Visit

Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

The Percentage of Participants With 2 or More Decreases From Baseline in iPTH of >= 50%

Time frame: Anytime during the study from Baseline to the participant's final visit (which could occur anytime from study initiation to Week 53)

Change in Mean iPTH

Time frame: Every week from Baseline through Week 13 and every other week thereafter until Week 53

Duration of 2 Consecutive Decreases in iPTH >= 50%

Time frame: From Baseline to the participant's Final Visit (which could occur anytime between study initiation and Week 53)

Data from ClinicalTrials.gov

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