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This study is a exploratory comparison of the efficacy and safety of paricalcitol injection with maxacalcitol injection in chronic kidney disease participants receiving hemodialysis with secondary hyperparathyroidism.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol | Experimental | 2 mcg adjusted by +/- 1 mcg, up to a maximum of 7 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis |
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| Maxacalcitol | Active Comparator | 5 or 10 mcg adjusted by +/- 2.5 mcg, up to a maximum of 20 mcg, administered 3 times per week through intravenous catheter immediately before completion of dialysis |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol | Drug | Intravenous administration 3 times a week immediately before completion of dialysis |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks. | Baseline and the last 3 weeks (Weeks 11, 12, and 13) |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks | During the last 3 weeks (Weeks 11, 12, and 13) | |
| Mean iPTH at Each Visit | Screening (up to 2 weeks before Baseline) to Week 13 |
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Inclusion Criteria:
Exclusion Criteria:
Patients taking drugs that affect iPTH, calcium, or bone metabolism
Patients with a history of allergic reaction or significant sensitivity to vitamin D
Patients who received parathyroidectomy or ethanol infusion within 1 year before informed consent was obtained
Patients with malignancy or with clinically significant hepatic disease (liver function tests more than 3 times the upper limit of normal) or with refractory hepatic disease
Patients with cardiovascular disease designated as New York Heart Association Class III or IV or with any of the following cardiovascular or cerebrovascular diseases within 6 months before informed consent was obtained:
Patients with severe hypertension (defined as mean resting blood pressure taken with the patient in a supine position before dialysis and at 6 dialyses sessions before informed consent was obtained: systolic >= 180 mmHg and diastolic >= 110 mmHg)
Patients with uncontrolled diabetes mellitus (defined as mean glycosylated hemoglobin >=8% for 3 months before informed consent was obtained)
Patients with a history of drug or alcohol abuse within 6 months before informed consent was obtained
Patients who require chronic use of cytochrome P450 (CYP3A) inhibitors or inducers
Patients who are taking products that contain aluminum 2 weeks before informed consent was obtained
Patients who have taken paricalcitol in the past
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| Name | Affiliation | Role |
|---|---|---|
| Moriaki Kubo | Abbott Japan Co.,Ltd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 53794 | Anjo | Japan | ||||
| Site Ref # / Investigator 53787 |
Informed consent was obtained from 92 subjects; 45 of these subjects were not enrolled because they did not meet the eligibility criteria at the time of Screening.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol | 2 mcg with incremental of 1 mcg |
| FG001 | Maxacalcitol | 5 or 10 mcg with incremental of 2.5 mcg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| maxacalcitol | Drug | Intravenous administration 3 times a week immediately before completion of dialysis |
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| Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks | Baseline and the last 3 weeks (Weeks 11, 12, and 13) |
| Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia |
| Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia |
| Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline | Over the 12-week treatment period |
| Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH | Over the 12-week treatment period |
| Chiba |
| Japan |
| Site Ref # / Investigator 53786 | Kumagaya | Japan |
| Site Ref # / Investigator 53792 | Matsumoto | Japan |
| Site Ref # / Investigator 53784 | Mito | Japan |
| Site Ref # / Investigator 53796 | Nagasaki | Japan |
| Site Ref # / Investigator 53795 | Osaka | Japan |
| Site Ref # / Investigator 21561 | Sapporo | Japan |
| Site Ref # / Investigator 53789 | Tokyo | Japan |
| Site Ref # / Investigator 53790 | Tokyo | Japan |
| Site Ref # / Investigator 53793 | Toyohashi | Japan |
| Site Ref # / Investigator 53785 | Tsuchiura | Japan |
| Site Ref # / Investigator 53788 | Yachiyo | Japan |
| Site Ref # / Investigator 53791 | Yokosuka | Japan |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol | 2 mcg with incremental of 1 mcg |
| BG001 | Maxacalcitol | 5 or 10 mcg with incremental of 2.5 mcg |
| 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 | ||||||||||||
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| Age, Categorical | Count of Participants | Participants |
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| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | The Percentage of Participants With a >=50% Reduction in Intact Parathyroid Hormone (iPTH) From Baseline Compared to the Average iPTH Obtained in the Last 3 Weeks. | All subjects who received at least 1 dose of study drug and who had at least 1 iPTH measurement while on treatment. | Posted | Number | Percentage of participants | Baseline and the last 3 weeks (Weeks 11, 12, and 13) |
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| Secondary | The Percentage of Participants With iPTH Within Target Range of 60-180 pg/mL, Based on the Average iPTH Obtained in the Last 3 Weeks | Posted | Number | Percentage of participants | During the last 3 weeks (Weeks 11, 12, and 13) |
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| Secondary | Mean iPTH at Each Visit | Posted | Mean | Standard Deviation | pg/mL | Screening (up to 2 weeks before Baseline) to Week 13 |
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| Secondary | Mean Change in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks | Posted | Mean | Standard Deviation | pg/mL | Baseline and the last 3 weeks (Weeks 11, 12, and 13) |
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| Secondary | Percentage of Participants With a >= 50% Reduction in iPTH From Baseline to the Average iPTH Obtained in the Last 3 Weeks and Without Hypercalcemia During Treatment | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | Posted | Number | Percentage of participants | Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia |
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| Secondary | Percentage of Participants With iPTH Within the Target Range of 60-180 pg/mL Based on the Average iPTH Obtained in the Last 3 Weeks of the Study and Without Hypercalcemia Anytime During Treatment | Hypercalcemia was defined as at least 1 corrected calcium > 11.5 mg/dL or at least 2 consecutive corrected calcium >= 11.0 mg/dL. | Posted | Number | Percentage of participants | Baseline and the last 3 weeks (Weeks 11, 12, and 13) for iPTH and anytime during the 12-week treatment period for hypercalcemia |
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| Secondary | Number of Occurrences of iPTH Control, Defined as >=50% Reduction in iPTH From Baseline | Posted | Mean | Standard Deviation | Occurrences per participant | Over the 12-week treatment period |
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| Secondary | Number of Occurrences of iPTH Control, Defined as Within the Target Range of 60-180 pg/mL of iPTH | Posted | Mean | Standard Deviation | Occurrences per participant | Over the 12-week treatment period |
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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 | 2 mcg with incremental of 1 mcg | 3 | 14 | 14 | 14 | ||
| EG001 | Maxacalcitol | 5 or 10 mcg with incremental of 2.5 mcg | 3 | 33 | 31 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cataract | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Pyothorax | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Skin papilloma | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
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| Lumbar spinal stenosis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
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| Eye pruritus | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Scleritis | Eye disorders | MedDRA 11.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Gingivitis | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Stomach discomfort | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Injection site dermatitis | General disorders | MedDRA 11.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 11.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Excoriation | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Shunt stenosis | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Wound | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
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| Blood pressure decreased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Serum ferritin increased | Investigations | MedDRA 11.0 | Systematic Assessment |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
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| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
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| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Hyperkeratosis | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Skin chapped | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 11.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 11.0 | Systematic Assessment |
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Abbott 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. Abbott 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 Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | 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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| >=65 years |
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| Male |
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