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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01187628
Recruitment Status : Completed
First Posted : August 24, 2010
Last Update Posted : April 3, 2015
Sponsor:
Collaborator:
Shire
Information provided by (Responsible Party):
Bayer

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hyperphosphatemia Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 123 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Study Start Date : September 2010
Primary Completion Date : April 2013
Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Arm 1 Drug: Fosrenol (Lanthanum Carbonate, BAY77-1931)
Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.



Primary Outcome Measures :
  1. Incidence of treatment emergent adverse events [ Time Frame: baseline to Week 60 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01187628


Locations
Japan
Anjo, Aichi, Japan, 446-8602
Nagoya, Aichi, Japan, 455-8530
Nagoya, Aichi, Japan, 457-8510
Nagoya, Aichi, Japan, 460-0001
Nagoya, Aichi, Japan, 466-8650
Seto, Aichi, Japan, 489-8642
Toyohashi, Aichi, Japan, 441-8021
Yatomi, Aichi, Japan, 498-8502
Kamogawa, Chiba, Japan, 296-0041
Kisarazu, Chiba, Japan, 292-8535
Kitakyushu, Fukuoka, Japan, 802-0001
Kitakyushu, Fukuoka, Japan, 805-0050
Koga, Fukuoka, Japan, 811-3195
Sapporo, Hokkaido, Japan, 063-0005
Amagasaki, Hyogo, Japan, 660-0828
Fujisawa, Kanagawa, Japan, 251-8550
Kamakura, Kanagawa, Japan, 247-8533
Yokohama, Kanagawa, Japan, 231-8682
Yokohama, Kanagawa, Japan, 234-8503
Beppu, Oita, Japan, 874-0011
Kurashiki, Okayama, Japan, 710-8602
Sakai, Osaka, Japan, 591-8025
Koto, Tokyo, Japan, 136-0075
Meguro-ku, Tokyo, Japan, 152-8902
Minato-ku, Tokyo, Japan, 105-8471
Musashino, Tokyo, Japan, 180-8610
Shinagawa, Tokyo, Japan, 141-8625
Fukuoka, Japan, 810-8563
Fukuoka, Japan, 814-0180
Kyoto, Japan, 612-8555
Oita, Japan, 870-0263
Okayama, Japan, 700-0013
Osaka, Japan, 530-0012
Osaka, Japan, 530-8480
Osaka, Japan, 534-0021
Osaka, Japan, 558-8558
Saga, Japan, 840-0054
Shizuoka, Japan, 421-0193
Tokushima, Japan, 770-0011
Wakayama, Japan, 641-8510
Sponsors and Collaborators
Bayer
Shire
Investigators
Study Director: Bayer Study Director Bayer

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01187628     History of Changes
Other Study ID Numbers: 15074
First Posted: August 24, 2010    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: April 2015

Keywords provided by Bayer:
Long-term study in Chronic Kidney Disease
Lanthanum Carbonate

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Hyperphosphatemia
Urologic Diseases
Renal Insufficiency
Phosphorus Metabolism Disorders
Metabolic Diseases