check_circleStudy Completed
Hyperphosphatemia
Bayer Identifier:
14817
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study in chronic kidney disease (CKD) not on dialysis
Trial purpose
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.
Key Participants Requirements
Sex
BothAge
20 YearsTrial summary
Enrollment Goal
143Trial Dates
June 2010 - November 2011Phase
Phase 3Could I Receive a placebo
YesProducts
Fosrenol (Lanthanum Carbonate, BAY77-1931)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Wakayama Medical University Hospital | Wakayama, 641-8510, Japan |
Completed | Osaka General Medical Center | Osaka, 558-8558, Japan |
Completed | Osaka Rosai Hospital | Sakai, 591-8025, Japan |
Completed | Osaka Saiseikai Nakatsu Hospital | Osaka, 530-0012, Japan |
Completed | Kitano Hospital | Osaka, 530-8480, Japan |
Completed | Okayama Saiseikai General Hospital | Okayama, 700-0013, Japan |
Completed | Kurashiki Central Hospital | Kurashiki, 710-8602, Japan |
Completed | The Jikei University Hospital | Minato-ku, 105-8471, Japan |
Completed | Chubu Rosai Hospital | Nagoya, 455-8530, Japan |
Completed | Juntendo Tokyo Koto Geriatric Medical Center | Koto, 136-0075, Japan |
Completed | Fujisawa City Hospital | Fujisawa, 251-8550, Japan |
Completed | Narita Memorial Hospital | Toyohashi, 441-8021, Japan |
Completed | Kawashima Hospital | Tokushima, 770-0011, Japan |
Completed | Osaka City General Hospital | Osaka, 534-0021, Japan |
Completed | NTT Medical Center Tokyo | Shinagawa, 141-8625, Japan |
Completed | Musashino Red Cross Hospital | Musashino, 180-8610, Japan |
Completed | Shonan Kamakura General Hospital | Kamakura, 247-8533, Japan |
Completed | Kameda Clinic | Kamogawa, 296-0041, Japan |
Completed | Kainan Hospital | Yatomi, 498-8502, Japan |
Completed | Nagoya Daini Red Cross Hospital | Nagoya, 466-8650, Japan |
Completed | Kyushu Medical Center | Fukuoka, 810-8563, Japan |
Completed | Kyoto Medical Center | Kyoto, 612-8555, Japan |
Completed | Beppu Medical Center | Beppu, 874-0011, Japan |
Completed | Oita Medical Center | Oita, 870-0263, Japan |
Completed | Nagoya Medical Center | Nagoya, 460-0001, Japan |
Completed | Tokyo Medical Center | Meguro-ku, 152-8902, Japan |
Completed | Shizuoka Tokushukai Hospital | Shizuoka, 421-0193, Japan |
Terminated | Social Insurance Chukyo Hospital | Nagoya, 457-8510, Japan |
Completed | Tosei General Hospital | Seto, 489-8642, Japan |
Terminated | Fukuoka University Hospital | Fukuoka, 814-0180, Japan |
Completed | Saga-Ken Medical Centre Koseikan | Saga, 840-0054, Japan |
Completed | Hokkaido Medical Center | Sapporo, 063-0005, Japan |
Completed | Kimitsu Chuo Hospital | Kisarazu, 292-8535, Japan |
Completed | Kokura Memorial Hospital | Kitakyushu, 802-8555, Japan |
Completed | National Fukuoka-Higashi Medical Center | Koga, 811-3195, Japan |
Completed | Hyogo Prefectural Amagasaki Hospital | Amagasaki, 660-0828, Japan |
Completed | Saiseikai Yokohamashi Nanbu Hospital | Yokohama, 234-8503, Japan |
Completed | Saiseikai Yahata General Hospital | Kitakyushu, 805-0050, Japan |
Completed | Yokohama City Minato Red Cross Hospital | Yokohama, 231-8682, Japan |
Completed | Anjo Kosei Hospital | Anjo, 446-8602, Japan |
Primary Outcome
- The change from baseline in serum phosphate concentrationsdate_rangeTime Frame:Week 8enhanced_encryptionnoSafety Issue:
Secondary Outcome
- Achievement of target serum phosphate level (2.7 to 4.6 mg/dL)date_rangeTime Frame:Week 0, Week 2, Week 4, Week 6, Week 8enhanced_encryptionnoSafety Issue:
- Change in serum Calcium x Phosphor productdate_rangeTime Frame:Week 0, Week 2, Week 4, Week 6, Week 8enhanced_encryptionNoSafety Issue:
- Serum intact PTH leveldate_rangeTime Frame:Week 0, Week 2, Week 4, Week 6, Week 8enhanced_encryptionnoSafety Issue:
- Phosphate excretion in urinedate_rangeTime Frame:Week 0, Week 4, Week 8enhanced_encryptionnoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2