Clinical trial NCT01110629: Study in Chronic Kidney Disease (CKD) Not on Dialysis
Official title: Randomized, Double-blind, Parallel-group, Placebo-controlled Study of Lanthanum Carbonate 750 to 2250 mg in Patients With Chronic Kidney Disease Not on Dialysis Who Develop Hyperphosphatemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperphosphatemia
Keywords: Chronic kidney disease not on dialysis
Lanthanum carbonate
Lead sponsor: Bayer
Sponsor class: INDUSTRY
Collaborators: name: Shire
First posted: 2010-04-26
Enrollment: 143
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: The objective of this study is to investigate the efficacy and safety of lanthanum carbonate 750 to 2,250 mg in Japanese Chronic Kidney Disease Stage 3, 4 and 5 subjects not on dialysis.


Eligibility criteria: Inclusion Criteria:

* Male and female patients aged 20 years or above at the time of informed consent
* Chronic Kidney Disease patients with Epidermal growth factor receptor (eGFR) under 60 ml/min/1.73m2 (stage 3, 4 and 5) who have not been on dialysis
* Patients who had been in the care of a physician for Chronic Kidney Disease for \>2 months and was not expected to begin dialysis for at least 4 months
* Patients with serum phosphate levels 5.6 mg/dL to 11.0 mg/dL at Week -4 (Visit 1) or Week -2 (Visit 2)

Exclusion Criteria:

* Patients with hypocalcemia or hypercalcemia (corrected serum calcium level of \< 7.0 mg/dL or \>/- 11.0 mg/dL) at Week -2 (Visit 2).
* Significant renal impairments
* Had acute renal failure within 3 months of Run-in period

Primary outcomes:
measure: The change from baseline in serum phosphate concentrations
timeFrame: Week 8
Secondary outcomes:
measure: Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
timeFrame: Week 0, Week 2, Week 4, Week 6, Week 8
measure: Change in serum Calcium x Phosphor product
timeFrame: Week 0, Week 2, Week 4, Week 6, Week 8
measure: Serum intact PTH level
timeFrame: Week 0, Week 2, Week 4, Week 6, Week 8
measure: Phosphate excretion in urine
timeFrame: Week 0, Week 4, Week 8
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:
citation: Takahara Y, Matsuda Y, Takahashi S, Shigematsu T; Lanthanum Carbonate Study Group. Efficacy and safety of lanthanum carbonate in pre-dialysis CKD patients with hyperphosphatemia: a randomized trial. Clin Nephrol. 2014 Sep;82(3):181-90. doi: 10.5414/cn108269.