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This study is a comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in adult Japanese chronic kidney disease patients receiving hemodialysis with secondary hyperparathyroidism. The main objective of this study is to demonstrate the efficacy of paricalcitol injection in reducing levels of parathyroid hormone without clinically significant hypercalcemia, compared to maxacalcitol injection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. |
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| Maxacalcitol | Active Comparator | Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug |
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| maxacalcitol |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kazuya Kobayashi, BA | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 53485 | Aichi | Japan | ||||
| Site Reference ID/Investigator# 51571 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Drug |
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| paricalcitol placebo | Drug |
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| maxacalcitol placebo | Drug |
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| 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 |
| 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 | Japan |
| Site Reference ID/Investigator# 57483 | Himeji | Japan |
| Site Reference ID/Investigator# 57487 | Hokkaido | Japan |
| Site Reference ID/Investigator# 53484 | Hyōgo | 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 | Japan |
| Maxacalcitol |
Participants received maxacalcitol at an initial dose of 5 µg (intact parathyroid hormone [iPTH] < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol | Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. |
| BG001 | Maxacalcitol | Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
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| Duration of hemodialysis | Mean | Standard Deviation | years |
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| Intact parathyroid hormone level | Mean | Standard Deviation | pg/mL |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The per-protocol set (PPS) consists of all randomized patients who completed at least 8 weeks of treatment and met the conditions specified by the subject classification (i.e., no violation of inclusion/exclusion criteria) that occurred before the study blind was broken. | Posted | Number | 95% Confidence Interval | percentage of participants | iPTH measured during the last three weeks of treatment (Weeks 11, 12, and 13). Calcium measured throughout the study (Weeks 1-13). |
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| ||||||||||||||||||||||||||||
| 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. | The Full Analysis Set (FAS) consists of all randomized patients who received at least 1 dose of study drug and had at least 1 post-baseline iPTH measurement. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) for iPTH. Calcium measured throughout the study (Weeks 1-13). |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | The last three weeks of treatment (Weeks 11, 12, and 13) |
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| Secondary | 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. | Full analysis set | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline to the last three weeks of treatment (Weeks 11, 12, and 13) |
| ||||||||||||||||||||||||||||||
| Secondary | 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. | Full analysis set | Posted | Mean | Standard Deviation | visits | Weeks 2 to 13 |
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| Secondary | 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. | Full analysis set | Posted | Mean | Standard Deviation | visits | Weeks 2 to 13 |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol | Participants received paricalcitol at an initial dose of 2 µg, and maxacalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 1 µg based on protocol-specified criteria up to a maximum of 7 µg. | 10 | 127 | 118 | 127 | ||
| EG001 | Maxacalcitol | Participants received maxacalcitol at an initial dose of 5 µg (iPTH < 500 pg/mL at Screening) or 10 µg (iPTH ≥ 500 pg/mL at Screening), and paricalcitol placebo administered 3 times per week at each hemodialysis via intravenous catheter for 12 weeks. After 2 weeks the dose could be adjusted ± 2.5 µg based on protocol-specified criteria up to a maximum of 20 µg. | 15 | 128 | 123 | 128 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Sinus bradycardia | Cardiac disorders | MedDRA (14.1) | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
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| Vertigo | Ear and labyrinth disorders | MedDRA (14.1) | Systematic Assessment |
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| Parathyroid gland enlargement | Endocrine disorders | MedDRA (14.1) | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA (14.1) | Systematic Assessment |
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| Colonic polyp | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Shunt malfunction | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Shunt occlusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Tendon rupture | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Carpal tunnel syndrome | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Thalamus haemorrhage | Nervous system disorders | MedDRA (14.1) | Systematic Assessment |
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| Renal disorder in pregnancy | Renal and urinary disorders | MedDRA (14.1) | Systematic Assessment | The patient was not pregnant during the study, but had a past medical history of pregnancy-induced kidney disorder |
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| Prostatitis | Reproductive system and breast disorders | MedDRA (14.1) | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA (14.1) | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment | All excoriation events in this study were trauma-related |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA (14.1) | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA (14.1) | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (14.1) | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA (14.1) | Systematic Assessment |
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AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbvie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
| C051883 | maxacalcitol |
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| Male |
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| Other |
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