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Clinical Trial Details

Trial ID: L1663
Source ID: NCT01341782
Associated Drug: Paricalcitol
Title: Comparison of Efficacy and Safety of Paricalcitol Injection With Maxacalcitol Injection in Adult Japanese Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT01341782/results
Conditions: Secondary Hyperparathyroidism|Hemodialysis
Interventions: DRUG: paricalcitol|DRUG: maxacalcitol|DRUG: paricalcitol placebo|DRUG: maxacalcitol placebo
Outcome Measures: Primary: Percentage of Participants With Target Intact Parathyroid Hormone (iPTH) and Without Hypercalcemia, The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment, and with no hypercalcemia during the treatment phase. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory., iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13). | Secondary: Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline and With No Hypercalcemia, The percentage of participants with greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment and with no hypercalcemia during the treatment phase. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory. Hypercalcemia was defined as at least 1 corrected calcium value \> 11.0 mg/dL or at least 2 corrected calcium values ≥ 10.5 mg/dL., Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13).|Percentage of Participants With Target Intact Parathyroid Hormone (iPTH), The target iPTH range was 60-180 pg/mL, based on the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory., The last three weeks of treatment (Weeks 11, 12, and 13)|Percentage of Participants With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline, The percentage of participants with a greater than or equal to 50% reduction in intact parathyroid hormone (iPTH) from baseline to the average of the last 3 weeks of treatment. iPTH was measured before the first dialysis session of each week and analyzed by the central laboratory., Baseline to the last three weeks of treatment (Weeks 11, 12, and 13)|Number of Visits at Which Participants Achieved iPTH Control With ≥ 50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline, iPTH control was defined as a ≥ 50% reduction from baseline. iPTH was measured before the first dialysis session of the week, each week during the treatment phase and analyzed by the central laboratory., Weeks 2 to 13|Number of Visits at Which Participants Achieved iPTH Control in the Target Range of 60 to 180 pg/mL, iPTH control was defined as being within the target range of 60 to 180 pg/mL. iPTH was measured before the first dialysis session of the week, once a week during the treatment phase and analyzed by the central laboratory., Weeks 2 to 13
Sponsor/Collaborators: Sponsor: AbbVie (prior sponsor, Abbott)
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 255
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2011-05
Completion Date: 2012-04
Results First Posted: 2013-06-06
Last Update Posted: 2013-06-06
Locations: Site Reference ID/Investigator# 53485, Aichi, Japan|Site Reference ID/Investigator# 51571, Chiba, Japan|Site Reference ID/Investigator# 52963, Chiba, Japan|Site Reference ID/Investigator# 52966, Chiba, Japan|Site Reference ID/Investigator# 51578, Gifu, Japan|Site Reference ID/Investigator# 52965, Gunma, Japan|Site Reference ID/Investigator# 53782, Hadano-City, Japan|Site Reference ID/Investigator# 57483, Himeji-City, Japan|Site Reference ID/Investigator# 57487, Hokkaido, Japan|Site Reference ID/Investigator# 53484, Hyogo, Japan|Site Reference ID/Investigator# 54385, Ibaraki, Japan|Site Reference ID/Investigator# 51581, Kagawa, Japan|Site Reference ID/Investigator# 59164, Kagoshima, Japan|Site Reference ID/Investigator# 51574, Kanagawa, Japan|Site Reference ID/Investigator# 51575, Kanagawa, Japan|Site Reference ID/Investigator# 52751, Kodaira, Japan|Site Reference ID/Investigator# 62025, Koga, Japan|Site Reference ID/Investigator# 54384, Matsumoto, Japan|Site Reference ID/Investigator# 52745, Midori, Japan|Site Reference ID/Investigator# 51569, Mito, Japan|Site Reference ID/Investigator# 52964, Nagano, Japan|Site Reference ID/Investigator# 53483, Nagano, Japan|Site Reference ID/Investigator# 51582, Nagasaki, Japan|Site Reference ID/Investigator# 54388, Nagoya, Japan|Site Reference ID/Investigator# 51576, Niigata, Japan|Site Reference ID/Investigator# 51577, Niigata, Japan|Site Reference ID/Investigator# 51580, Osaka, Japan|Site Reference ID/Investigator# 52747, Osaka, Japan|Site Reference ID/Investigator# 52748, Osaka, Japan|Site Reference ID/Investigator# 52750, Osaka, Japan|Site Reference ID/Investigator# 51570, Saitama, Japan|Site Reference ID/Investigator# 54387, Sakai, Japan|Site Reference ID/Investigator# 52746, Sapporo, Japan|Site Reference ID/Investigator# 51579, Shizuoka, Japan|Site Reference ID/Investigator# 62024, Takasaki, Japan|Site Reference ID/Investigator# 51572, Tokyo, Japan|Site Reference ID/Investigator# 52752, Tokyo, Japan|Site Reference ID/Investigator# 53482, Tokyo, Japan|Site Reference ID/Investigator# 59162, Tokyo, Japan|Site Reference ID/Investigator# 59966, Tokyo, Japan|Site Reference ID/Investigator# 53783, Tomakomai-shi, Japan|Site Reference ID/Investigator# 54383, Toyama, Japan|Site Reference ID/Investigator# 52749, Wakayama, Japan|Site Reference ID/Investigator# 52962, Yachiyoshi, Japan|Site Reference ID/Investigator# 59163, Yokohama-Shi, Japan
URL: https://clinicaltrials.gov/show/NCT01341782