Clinical trial NCT01514851: Phase III Double-blind Comparative Study of BAY77-1931 (Lanthanum Carbonate) With Calcium Carbonate
Official title: Phase III Double-blind Comparative Study of BAY 77 1931 (Lanthanum Carbonate) With a Calcium Carbonate in Patients With Hyperphosphatemia Undergoing Hemodialysis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Keywords: Hyperphosphatemia in ESRD (End Stage Renal Disease) patients on dialysis
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2012-01-23
Enrollment: 259
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess the effect on reduction of serum phosphate and the safety of BAY77-1931 (Lanthanum Carbonate) in patients with hyperphosphatemia undergoing hemodialysis in a randomized, double-blind, parallel group study in comparison with Calcium carbonate.


Eligibility criteria: Inclusion Criteria:

* Pre-dialysis serum phosphate levels: ≧5.6 mg/dL and \<11.0 mg/dL at 1 week after the initiation of the washout period.
* Out-patient
* Undergoing hemodialysis three times per week for at least previous 3 consecutive months

Exclusion Criteria:

* Pre-dialysis serum phosphate levels of ≧10.0 mg/dL at the start of the washout period or ≧11.0 mg/dL at 1 week after
* Corrected serum calcium level of \<7.0 mg/dL or ≧11.0 mg/dL at the start of the washout period and/or 1 week after
* Serum intact PTH (Parathyroid) of ≧1000 pg/mL at the start of the washout period
* Pregnant woman, or lactating mother
* Significant gastrointestinal disorders including known acute peptic ulcer
* Liver dysfunction
* History of cardiovascular or cerebrovascular diseases
* Requiring treatment for hypothyroidism

Primary outcomes:
measure: Change from baseline in pre-dialysis serum phosphate levels (PSPL) at the end of the double-blind period
timeFrame: baseline to week 8
measure: Presence/absence of incidence of hypercalcemia up to 8 weeks
timeFrame: up to 8 weeks
Secondary outcomes:
measure: Number of participants achieving target PSPL and time to achievement
timeFrame: up to 8 weeks
measure: Serum calcium x phosphate product at the end of the double-blind treatment period
timeFrame: Week 8
measure: Serum intact-PTH (Parathyroid) levels
timeFrame: Week 8
measure: Serum calcium level corrected by serum albumin level at the end of the double-blind treatment period
timeFrame: Week 8
measure: Number of participants achieving the target serum calcium levels
timeFrame: Week 8
measure: Safety variables will be summarized using descriptive statistics based on adverse events collection
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Toyohashi
country: Japan
state: Aichi
city: Yatomi
country: Japan
state: Aichi
city: Asahi
country: Japan
state: Chiba
city: Kashiwa
country: Japan
state: Chiba
city: Matsudo
country: Japan
state: Chiba
city: Narita
country: Japan
state: Chiba
city: Kurume
country: Japan
state: Fukuoka
city: Kurume
country: Japan
state: Fukuoka
city: Isesaki
country: Japan
state: Gunma
city: Kobe
country: Japan
state: Hyogo
city: Mito
country: Japan
state: Ibaraki
city: Tsuchiura
country: Japan
state: Ibaraki
city: Takamatsu
country: Japan
state: Kagawa
city: Osaki
country: Japan
state: Miyagi
city: Sendai
country: Japan
state: Miyagi
city: Suita
country: Japan
state: Osaka
city: Fuji
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Arakawa-ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Nerima-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Shinjyuku-ku
country: Japan
state: Tokyo
city: Chiba
country: Japan
city: Hiroshima
country: Japan
city: Kochi
country: Japan
city: Okayama
country: Japan
city: Saitama
country: Japan
city: Saitama
country: Japan
city: Saitama
country: Japan
city: Tokushima
country: Japan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: