Clinical trial NCT01187628: Long-term Study in Chronic Kidney Disease (Extension From Study 14817)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Keywords: Long-term study in Chronic Kidney Disease
Lanthanum Carbonate
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Shire
First posted: 2010-08-24
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Incidence of treatment emergent adverse events
timeFrame: baseline to Week 60
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Nagoya
country: Japan
state: Aichi
city: Seto
country: Japan
state: Aichi
city: Toyohashi
country: Japan
state: Aichi
city: Yatomi
country: Japan
state: Aichi
city: Kamogawa
country: Japan
state: Chiba
city: Kisarazu
country: Japan
state: Chiba
city: Kitakyushu
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Koga
country: Japan
state: Fukuoka
city: Sapporo
country: Japan
state: Hokkaido
city: Amagasaki
country: Japan
state: Hyogo
city: Fujisawa
country: Japan
state: Kanagawa
city: Kamakura
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Beppu
country: Japan
state: Oita
city: Kurashiki
country: Japan
state: Okayama
city: Sakai
country: Japan
state: Osaka
city: Koto
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Minato-ku
country: Japan
state: Tokyo
city: Musashino
country: Japan
state: Tokyo
city: Shinagawa
country: Japan
state: Tokyo
city: Fukuoka
country: Japan
city: Fukuoka
country: Japan
city: Kyoto
country: Japan
city: Oita
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Osaka
country: Japan
city: Saga
country: Japan
city: Shizuoka
country: Japan
city: Tokushima
country: Japan
city: Wakayama
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: