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Sponsors and Collaborators: |
Abbott Abbott Japan Co.,Ltd |
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Information provided by: | Abbott |
ClinicalTrials.gov Identifier: | NCT00667576 |
To examine the dose response of paricalcitol injection, subjects will administer clinical supplies 3 times a week, 12 weeks at dialysis session in dose-titration manner.
Condition | Intervention | Phase |
---|---|---|
Secondary Hyperparathyroidism Hemodialysis |
Drug: paricalcitol Drug: maxacalcitol |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Dose-Response Study of Paricalcitol Injection in Chronic Kidney Disease Subjects Receiving Hemodialysis With Secondary Hyperparathyroidism (Examination of Initial Dose and Incremental Dose) |
Enrollment: | 153 |
Study Start Date: | April 2008 |
Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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paricalcitol A group: Experimental
2 mcg with incremental of 1 mcg
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Drug: paricalcitol
IV, See Arm Description for dosage information
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paricalcitol B group: Experimental
2 mcg with incremental of 2 mcg
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Drug: paricalcitol
IV, See Arm Description for dosage information
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paricalcitol C group: Experimental
4 mcg with incremental of 1 mcg
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Drug: paricalcitol
IV, See Arm Description for dosage information
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paricalcitol D group: Experimental
4 mcg with incremental of 2 mcg
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Drug: paricalcitol
IV, See Arm Description for dosage information
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maxacalcitol E group: Active Comparator
5 or 10 mcg with incremental of 2.5 mcg
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Drug: maxacalcitol
IV, 5 mcg or 10 mcg with incremental dose of 2.5 mcg
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Ages Eligible for Study: | 20 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Japan, Metropolis | |
Tokyo, Metropolis, Japan | |
Japan, Prefecture | |
Hokkaido, Prefecture, Japan | |
Ibaragi, Prefecture, Japan | |
Saitama, Prefecture, Japan | |
Chiba, Prefecture, Japan | |
Kanagawa, Prefecture, Japan | |
Kumamoto, Prefecture, Japan | |
Aichi, Prefecture, Japan | |
Osaka, Prefecture, Japan | |
Fukuoka, Prefecture, Japan | |
Nagasaki, Prefecture, Japan | |
Nagano, Prefecture, Japan |
Study Director: | Ryotaro Matsuzawa | Abbott |
Responsible Party: | Abbott ( Yoshihiko Ueki ) |
Study ID Numbers: | M10-309 |
Study First Received: | April 24, 2008 |
Last Updated: | April 14, 2009 |
ClinicalTrials.gov Identifier: | NCT00667576 History of Changes |
Health Authority: | Japan: Ministry of Health, Labor and Welfare |
secondary hyperparathyroidism hemodialysis paricalcitol maxacalcitol |
Anticarcinogenic Agents Parathyroid Diseases Renal Insufficiency Ergocalciferols Kidney Failure, Chronic Endocrine System Diseases Trace Elements Bone Density Conservation Agents Hyperparathyroidism, Secondary Maxacalcitol |
Hyperparathyroidism Urologic Diseases Renal Insufficiency, Chronic Vitamins Neoplasm Metastasis Micronutrients Kidney Diseases Endocrinopathy Kidney Failure |
Anticarcinogenic Agents Parathyroid Diseases Renal Insufficiency Antineoplastic Agents Physiological Effects of Drugs Kidney Failure, Chronic Bone Density Conservation Agents Neoplastic Processes Hyperparathyroidism, Secondary Maxacalcitol Pathologic Processes Urologic Diseases Therapeutic Uses Vitamins |
Neoplasm Metastasis Micronutrients Kidney Diseases Dermatologic Agents Growth Substances Ergocalciferols Endocrine System Diseases Protective Agents Pharmacologic Actions Neoplasms Hyperparathyroidism Renal Insufficiency, Chronic Kidney Failure |