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Clinical Trial Details

Trial ID: L1283
Source ID: NCT01110629
Associated Drug: Fosrenol (Lanthanum Carbonate, Bay77-1931)
Title: Study in Chronic Kidney Disease (CKD) Not on Dialysis
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Hyperphosphatemia
Interventions: DRUG: Fosrenol (Lanthanum Carbonate, BAY77-1931)|DRUG: Placebo
Outcome Measures: Primary: The change from baseline in serum phosphate concentrations, Week 8 | Secondary: 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
Sponsor/Collaborators: Sponsor: Bayer | Collaborators: Shire
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 143
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2010-06
Completion Date: 2011-11
Results First Posted:
Last Update Posted: 2014-10-15
Locations: Anjo, Aichi, 446-8602, Japan|Nagoya, Aichi, 455-8530, Japan|Nagoya, Aichi, 457-8510, Japan|Nagoya, Aichi, 460-0001, Japan|Nagoya, Aichi, 466-8650, Japan|Seto, Aichi, 489-8642, Japan|Toyohashi, Aichi, 441-8021, Japan|Yatomi, Aichi, 498-8502, Japan|Kamogawa, Chiba, 296-0041, Japan|Kisarazu, Chiba, 292-8535, Japan|Kitakyushu, Fukuoka, 802-8555, Japan|Kitakyushu, Fukuoka, 805-0050, Japan|Koga, Fukuoka, 811-3195, Japan|Sapporo, Hokkaido, 063-0005, Japan|Amagasaki, Hyogo, 660-0828, Japan|Fujisawa, Kanagawa, 251-8550, Japan|Kamakura, Kanagawa, 247-8533, Japan|Yokohama, Kanagawa, 231-8682, Japan|Yokohama, Kanagawa, 234-8503, Japan|Beppu, Oita, 874-0011, Japan|Kurashiki, Okayama, 710-8602, Japan|Sakai, Osaka, 591-8025, Japan|Koto, Tokyo, 136-0075, Japan|Meguro-ku, Tokyo, 152-8902, Japan|Minato-ku, Tokyo, 105-8471, Japan|Musashino, Tokyo, 180-8610, Japan|Shinagawa, Tokyo, 141-8625, Japan|Fukuoka, 810-8563, Japan|Fukuoka, 814-0180, Japan|Kyoto, 612-8555, Japan|Oita, 870-0263, Japan|Okayama, 700-0013, Japan|Osaka, 530-0012, Japan|Osaka, 530-8480, Japan|Osaka, 534-0021, Japan|Osaka, 558-8558, Japan|Saga, 840-0054, Japan|Shizuoka, 421-0193, Japan|Tokushima, 770-0011, Japan|Wakayama, 641-8510, Japan
URL: https://clinicaltrials.gov/show/NCT01110629