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Long-term Study in Chronic Kidney Disease (Extension From Study 14817)

NCT ID: NCT01187628

Last Updated: 2015-04-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

123 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-04-30

Brief Summary

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The objective of this study is to investigate the safety and the effect on reduction of serum phosphate of long-term administration of lanthanum carbonate (BAY77-1931) 750 to 2250 mg in patients with hyperphosphatemia who completed the 8 week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study.

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Detailed Description

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Conditions

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Hyperphosphatemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

Fosrenol (Lanthanum Carbonate, BAY77-1931)

Intervention Type DRUG

Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Interventions

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Fosrenol (Lanthanum Carbonate, BAY77-1931)

Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who have completed the 8-week double-blind treatment period of Study 14817 and are judged to be eligible for the long-term extension study by the investigator (including those who plan to be on dialysis during the long-term extension study).

Exclusion Criteria

* Patients with any other conditions that the investigator defines as not appropriate to be enrolled in the study
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role collaborator

Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Anjo, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Nagoya, Aichi-ken, Japan

Site Status

Seto, Aichi-ken, Japan

Site Status

Toyohashi, Aichi-ken, Japan

Site Status

Yatomi, Aichi-ken, Japan

Site Status

Kamogawa, Chiba, Japan

Site Status

Kisarazu, Chiba, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Fukuoka, Fukuoka, Japan

Site Status

Kitakyushu, Fukuoka, Japan

Site Status

Kitakyushu, Fukuoka, Japan

Site Status

Koga, Fukuoka, Japan

Site Status

Sapporo, Hokkaido, Japan

Site Status

Amagasaki, Hyōgo, Japan

Site Status

Fujisawa, Kanagawa, Japan

Site Status

Kamakura, Kanagawa, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Yokohama, Kanagawa, Japan

Site Status

Kyoto, Kyoto, Japan

Site Status

Beppu, Oita Prefecture, Japan

Site Status

Ōita, Oita Prefecture, Japan

Site Status

Kurashiki, Okayama-ken, Japan

Site Status

Okayama, Okayama-ken, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Osaka, Osaka, Japan

Site Status

Sakai, Osaka, Japan

Site Status

Saga, Saga-ken, Japan

Site Status

Shizuoka, Shizuoka, Japan

Site Status

Tokushima, Tokushima, Japan

Site Status

Koto, Tokyo, Japan

Site Status

Meguro-ku, Tokyo, Japan

Site Status

Minato-ku, Tokyo, Japan

Site Status

Musashino, Tokyo, Japan

Site Status

Shinagawa, Tokyo, Japan

Site Status

Wakayama, Wakayama, Japan

Site Status

Countries

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Japan

Other Identifiers

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15074

Identifier Type: -

Identifier Source: org_study_id

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