Study in Chronic Kidney Disease (CKD) Not on Dialysis
Primary Purpose
Hyperphosphatemia
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hyperphosphatemia focused on measuring Chronic kidney disease not on dialysis, Lanthanum carbonate
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Arm 1
Arm 2
Arm Description
Outcomes
Primary Outcome Measures
The change from baseline in serum phosphate concentrations
Secondary Outcome Measures
Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
Change in serum Calcium x Phosphor product
Serum intact PTH level
Phosphate excretion in urine
Full Information
NCT ID
NCT01110629
First Posted
April 23, 2010
Last Updated
October 12, 2014
Sponsor
Bayer
Collaborators
Shire
1. Study Identification
Unique Protocol Identification Number
NCT01110629
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer
Collaborators
Shire
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperphosphatemia
Keywords
Chronic kidney disease not on dialysis, Lanthanum carbonate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
143 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Experimental
Arm Title
Arm 2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Fosrenol (Lanthanum Carbonate, BAY77-1931)
Intervention Description
Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
daily dose: 3 tablets TID for 8 weeks.
Primary Outcome Measure Information:
Title
The change from baseline in serum phosphate concentrations
Time Frame
Week 8
Secondary Outcome Measure Information:
Title
Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)
Time Frame
Week 0, Week 2, Week 4, Week 6, Week 8
Title
Change in serum Calcium x Phosphor product
Time Frame
Week 0, Week 2, Week 4, Week 6, Week 8
Title
Serum intact PTH level
Time Frame
Week 0, Week 2, Week 4, Week 6, Week 8
Title
Phosphate excretion in urine
Time Frame
Week 0, Week 4, Week 8
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
City
Anjo
State/Province
Aichi
ZIP/Postal Code
446-8602
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
455-8530
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
457-8510
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0001
Country
Japan
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
466-8650
Country
Japan
City
Seto
State/Province
Aichi
ZIP/Postal Code
489-8642
Country
Japan
City
Toyohashi
State/Province
Aichi
ZIP/Postal Code
441-8021
Country
Japan
City
Yatomi
State/Province
Aichi
ZIP/Postal Code
498-8502
Country
Japan
City
Kamogawa
State/Province
Chiba
ZIP/Postal Code
296-0041
Country
Japan
City
Kisarazu
State/Province
Chiba
ZIP/Postal Code
292-8535
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
802-8555
Country
Japan
City
Kitakyushu
State/Province
Fukuoka
ZIP/Postal Code
805-0050
Country
Japan
City
Koga
State/Province
Fukuoka
ZIP/Postal Code
811-3195
Country
Japan
City
Sapporo
State/Province
Hokkaido
ZIP/Postal Code
063-0005
Country
Japan
City
Amagasaki
State/Province
Hyogo
ZIP/Postal Code
660-0828
Country
Japan
City
Fujisawa
State/Province
Kanagawa
ZIP/Postal Code
251-8550
Country
Japan
City
Kamakura
State/Province
Kanagawa
ZIP/Postal Code
247-8533
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
231-8682
Country
Japan
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
234-8503
Country
Japan
City
Beppu
State/Province
Oita
ZIP/Postal Code
874-0011
Country
Japan
City
Kurashiki
State/Province
Okayama
ZIP/Postal Code
710-8602
Country
Japan
City
Sakai
State/Province
Osaka
ZIP/Postal Code
591-8025
Country
Japan
City
Koto
State/Province
Tokyo
ZIP/Postal Code
136-0075
Country
Japan
City
Meguro-ku
State/Province
Tokyo
ZIP/Postal Code
152-8902
Country
Japan
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
105-8471
Country
Japan
City
Musashino
State/Province
Tokyo
ZIP/Postal Code
180-8610
Country
Japan
City
Shinagawa
State/Province
Tokyo
ZIP/Postal Code
141-8625
Country
Japan
City
Fukuoka
ZIP/Postal Code
810-8563
Country
Japan
City
Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
City
Kyoto
ZIP/Postal Code
612-8555
Country
Japan
City
Oita
ZIP/Postal Code
870-0263
Country
Japan
City
Okayama
ZIP/Postal Code
700-0013
Country
Japan
City
Osaka
ZIP/Postal Code
530-0012
Country
Japan
City
Osaka
ZIP/Postal Code
530-8480
Country
Japan
City
Osaka
ZIP/Postal Code
534-0021
Country
Japan
City
Osaka
ZIP/Postal Code
558-8558
Country
Japan
City
Saga
ZIP/Postal Code
840-0054
Country
Japan
City
Shizuoka
ZIP/Postal Code
421-0193
Country
Japan
City
Tokushima
ZIP/Postal Code
770-0011
Country
Japan
City
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
25079863
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.
Results Reference
derived
Learn more about this trial
Study in Chronic Kidney Disease (CKD) Not on Dialysis
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