- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01187628
Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
April 2, 2015 updated by: Bayer
An Open-label, Long-term Extension Study of Lanthanum Carbonate 750 to 2,250 mg in Hyperphosphatemia in Patients With Chronic Kidney Disease Not on Dialysis (52 Weeks Extension From Study 14817)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
123
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Fukuoka, Japan, 810-8563
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Fukuoka, Japan, 814-0180
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Kyoto, Japan, 612-8555
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Oita, Japan, 870-0263
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Okayama, Japan, 700-0013
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Osaka, Japan, 530-8480
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Osaka, Japan, 558-8558
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Osaka, Japan, 534-0021
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Osaka, Japan, 530-0012
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Saga, Japan, 840-0054
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Shizuoka, Japan, 421-0193
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Tokushima, Japan, 770-0011
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Wakayama, Japan, 641-8510
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Aichi
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Anjo, Aichi, Japan, 446-8602
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Nagoya, Aichi, Japan, 455-8530
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Nagoya, Aichi, Japan, 457-8510
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Nagoya, Aichi, Japan, 460-0001
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Nagoya, Aichi, Japan, 466-8650
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Seto, Aichi, Japan, 489-8642
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Toyohashi, Aichi, Japan, 441-8021
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Yatomi, Aichi, Japan, 498-8502
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Chiba
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Kamogawa, Chiba, Japan, 296-0041
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Kisarazu, Chiba, Japan, 292-8535
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Fukuoka
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Kitakyushu, Fukuoka, Japan, 805-0050
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Kitakyushu, Fukuoka, Japan, 802-0001
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Koga, Fukuoka, Japan, 811-3195
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Hokkaido
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Sapporo, Hokkaido, Japan, 063-0005
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Hyogo
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Amagasaki, Hyogo, Japan, 660-0828
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Kanagawa
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Fujisawa, Kanagawa, Japan, 251-8550
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Kamakura, Kanagawa, Japan, 247-8533
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Yokohama, Kanagawa, Japan, 231-8682
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Yokohama, Kanagawa, Japan, 234-8503
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Oita
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Beppu, Oita, Japan, 874-0011
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Okayama
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Kurashiki, Okayama, Japan, 710-8602
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Osaka
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Sakai, Osaka, Japan, 591-8025
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Tokyo
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Koto, Tokyo, Japan, 136-0075
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Meguro-ku, Tokyo, Japan, 152-8902
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Minato-ku, Tokyo, Japan, 105-8471
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Musashino, Tokyo, Japan, 180-8610
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Shinagawa, Tokyo, Japan, 141-8625
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Arm 1
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Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Incidence of treatment emergent adverse events
Time Frame: baseline to Week 60
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baseline to Week 60
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2010
Primary Completion (Actual)
April 1, 2013
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 23, 2010
First Submitted That Met QC Criteria
August 23, 2010
First Posted (Estimate)
August 24, 2010
Study Record Updates
Last Update Posted (Estimate)
April 3, 2015
Last Update Submitted That Met QC Criteria
April 2, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15074
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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