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Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism

NCT ID: NCT01341782

Last Updated: 2013-06-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-04-30

Brief Summary

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This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.

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Detailed Description

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Conditions

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Secondary Hyperparathyroidism Hemodialysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Paricalcitol

Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg.

Group Type EXPERIMENTAL

paricalcitol

Intervention Type DRUG

maxacalcitol placebo

Intervention Type DRUG

Maxacalcitol

Participants received maxacalcitol at an initial dose of 5 µg (iPTH \< 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg.

Group Type ACTIVE_COMPARATOR

maxacalcitol

Intervention Type DRUG

paricalcitol placebo

Intervention Type DRUG

Interventions

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paricalcitol

Intervention Type DRUG

maxacalcitol

Intervention Type DRUG

paricalcitol placebo

Intervention Type DRUG

maxacalcitol placebo

Intervention Type DRUG

Other Intervention Names

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ABT-358 Zemplar oxarol

Eligibility Criteria

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Inclusion Criteria

* Adult Chronic Kidney Disease (CKD) Stage 5 patients undergoing dialysis with stable dialysate calcium and phosphate binders
* On three times weekly hemodialysis for at least 3 months prior with intact parathyroid hormone (iPTH) greater than or equal to 300 pg/mL, adjusted normalized serum total calcium (Ca) greater than or equal to 8.4 to less than 10.2 mg/dL, serum phosphorus (P) less than or equal to 6.5 mg/dL.

Exclusion Criteria

* Patients with a recent history of severe cardiovascular or hepatic disease, uncontrolled hypertension or uncontrolled diabetes
* Patients who have received a parathyroidectomy or ethanol infusion within the prior year
* Patients taking drugs that affect iPTH, calcium or bone metabolism
* Patients who will need to take chronic doses (greater than or equal to 2 consecutive weeks) of cytochrome P450 inhibitors (e.g., clarithromycin, grapefruit products) or inducers (e.g., carbamazepine, rifampicin)
* Female patients who are pregnant, possibly pregnant, wish to become pregnant, or participate in breastfeeding during the study period.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kazuya Kobayashi, BA

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 53485

Aichi, , Japan

Site Status

Site Reference ID/Investigator# 51571

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 52963

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 52966

Chiba, , Japan

Site Status

Site Reference ID/Investigator# 51578

Gifu, , Japan

Site Status

Site Reference ID/Investigator# 52965

Gunma, , Japan

Site Status

Site Reference ID/Investigator# 53782

Hadano, , Japan

Site Status

Site Reference ID/Investigator# 57483

Himeji, , Japan

Site Status

Site Reference ID/Investigator# 57487

Hokkaido, , Japan

Site Status

Site Reference ID/Investigator# 53484

Hyōgo, , Japan

Site Status

Site Reference ID/Investigator# 54385

Ibaraki, , Japan

Site Status

Site Reference ID/Investigator# 51581

Kagawa, , Japan

Site Status

Site Reference ID/Investigator# 59164

Kagoshima, , Japan

Site Status

Site Reference ID/Investigator# 51574

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 51575

Kanagawa, , Japan

Site Status

Site Reference ID/Investigator# 52751

Kodaira, , Japan

Site Status

Site Reference ID/Investigator# 62025

Koga, , Japan

Site Status

Site Reference ID/Investigator# 54384

Matsumoto, , Japan

Site Status

Site Reference ID/Investigator# 52745

Midori, , Japan

Site Status

Site Reference ID/Investigator# 51569

Mito, , Japan

Site Status

Site Reference ID/Investigator# 52964

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 53483

Nagano, , Japan

Site Status

Site Reference ID/Investigator# 51582

Nagasaki, , Japan

Site Status

Site Reference ID/Investigator# 54388

Nagoya, , Japan

Site Status

Site Reference ID/Investigator# 51576

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 51577

Niigata, , Japan

Site Status

Site Reference ID/Investigator# 51580

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 52747

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 52748

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 52750

Osaka, , Japan

Site Status

Site Reference ID/Investigator# 51570

Saitama, , Japan

Site Status

Site Reference ID/Investigator# 54387

Sakai, , Japan

Site Status

Site Reference ID/Investigator# 52746

Sapporo, , Japan

Site Status

Site Reference ID/Investigator# 51579

Shizuoka, , Japan

Site Status

Site Reference ID/Investigator# 62024

Takasaki, , Japan

Site Status

Site Reference ID/Investigator# 51572

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 52752

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 53482

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59162

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 59966

Tokyo, , Japan

Site Status

Site Reference ID/Investigator# 53783

Tomakomai-shi, , Japan

Site Status

Site Reference ID/Investigator# 54383

Toyama, , Japan

Site Status

Site Reference ID/Investigator# 52749

Wakayama, , Japan

Site Status

Site Reference ID/Investigator# 52962

Yachiyoshi, , Japan

Site Status

Site Reference ID/Investigator# 59163

Yokohama, , Japan

Site Status

Countries

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Japan

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M11-517

Identifier Type: -

Identifier Source: org_study_id

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