Study in Chronic Kidney Disease (CKD) Not on Dialysis
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
1 other identifier
interventional
143
1 country
40
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2010
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 23, 2010
CompletedFirst Posted
Study publicly available on registry
April 26, 2010
CompletedStudy Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2011
CompletedOctober 15, 2014
October 1, 2014
1.4 years
April 23, 2010
October 12, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change from baseline in serum phosphate concentrations
Week 8
Secondary Outcomes (4)
Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
Week 0, Week 2, Week 4, Week 6, Week 8
Change in serum Calcium x Phosphor product
Week 0, Week 2, Week 4, Week 6, Week 8
Serum intact PTH level
Week 0, Week 2, Week 4, Week 6, Week 8
Phosphate excretion in urine
Week 0, Week 4, Week 8
Study Arms (2)
Arm 1
EXPERIMENTALArm 2
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Unknown Facility
Anjo, Aichi-ken, 446-8602, Japan
Unknown Facility
Nagoya, Aichi-ken, 455-8530, Japan
Unknown Facility
Nagoya, Aichi-ken, 457-8510, Japan
Unknown Facility
Nagoya, Aichi-ken, 460-0001, Japan
Unknown Facility
Nagoya, Aichi-ken, 466-8650, Japan
Unknown Facility
Seto, Aichi-ken, 489-8642, Japan
Unknown Facility
Toyohashi, Aichi-ken, 441-8021, Japan
Unknown Facility
Yatomi, Aichi-ken, 498-8502, Japan
Unknown Facility
Kamogawa, Chiba, 296-0041, Japan
Unknown Facility
Kisarazu, Chiba, 292-8535, Japan
Unknown Facility
Fukuoka, Fukuoka, 810-8563, Japan
Unknown Facility
Fukuoka, Fukuoka, 814-0180, Japan
Unknown Facility
Kitakyushu, Fukuoka, 802-8555, Japan
Unknown Facility
Kitakyushu, Fukuoka, 805-0050, Japan
Unknown Facility
Koga, Fukuoka, 811-3195, Japan
Unknown Facility
Sapporo, Hokkaido, 063-0005, Japan
Unknown Facility
Amagasaki, Hyōgo, 660-0828, Japan
Unknown Facility
Fujisawa, Kanagawa, 251-8550, Japan
Unknown Facility
Kamakura, Kanagawa, 247-8533, Japan
Unknown Facility
Yokohama, Kanagawa, 231-8682, Japan
Unknown Facility
Yokohama, Kanagawa, 234-8503, Japan
Unknown Facility
Kyoto, Kyoto, 612-8555, Japan
Unknown Facility
Beppu, Oita Prefecture, 874-0011, Japan
Unknown Facility
Ōita, Oita Prefecture, 870-0263, Japan
Unknown Facility
Kurashiki, Okayama-ken, 710-8602, Japan
Unknown Facility
Okayama, Okayama-ken, 700-0013, Japan
Unknown Facility
Osaka, Osaka, 530-0012, Japan
Unknown Facility
Osaka, Osaka, 530-8480, Japan
Unknown Facility
Osaka, Osaka, 534-0021, Japan
Unknown Facility
Osaka, Osaka, 558-8558, Japan
Unknown Facility
Sakai, Osaka, 591-8025, Japan
Unknown Facility
Saga, Saga-ken, 840-0054, Japan
Unknown Facility
Shizuoka, Shizuoka, 421-0193, Japan
Unknown Facility
Tokushima, Tokushima, 770-0011, Japan
Unknown Facility
Koto, Tokyo, 136-0075, Japan
Unknown Facility
Meguro-ku, Tokyo, 152-8902, Japan
Unknown Facility
Minato-ku, Tokyo, 105-8471, Japan
Unknown Facility
Musashino, Tokyo, 180-8610, Japan
Unknown Facility
Shinagawa, Tokyo, 141-8625, Japan
Unknown Facility
Wakayama, Wakayama, 641-8510, Japan
Related Publications (2)
Natale P, Green SC, Ruospo M, Craig JC, Vecchio M, Elder GJ, Strippoli GF. Phosphate binders for preventing and treating chronic kidney disease-mineral and bone disorder (CKD-MBD). Cochrane Database Syst Rev. 2025 Jun 27;6(6):CD006023. doi: 10.1002/14651858.CD006023.pub4.
PMID: 40576086DERIVEDTakahara 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.
PMID: 25079863DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2010
First Posted
April 26, 2010
Study Start
June 1, 2010
Primary Completion
November 1, 2011
Study Completion
November 1, 2011
Last Updated
October 15, 2014
Record last verified: 2014-10