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| Name | Class |
|---|---|
| Almedis | INDUSTRY |
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Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5 Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be assessed during the study.
Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at thirteen sites in Russia. Study drug will be administered per local prescribing guidelines. Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening visit. All participants who meet the inclusion criteria and fail to meet the exclusion criteria will be included in the study.
Adverse events will be monitored throughout the observation period (and up to 30 days after the last dose of Zemplar).
Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300 pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured throughout the study.
The selected population is representative in relation to those who will take Zemplar in routine practice. Participants with contraindications to Zemplar therapy (as per the local label) will not be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stage 5 Chronic Kidney Disease | Planned for Zemplar administration due to secondary hyperparathyroidism |
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| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study | The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded. |
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Inclusion Criteria:
Exclusion Criteria:
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Hemodialysis centers
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| Name | Affiliation | Role |
|---|---|---|
| Andrey Strugovshchikov, MD | AbbVie LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 57348 | Al'met'yevsk | 423450 | Russia | |||
| Site Reference ID/Investigator# 57347 |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Stage 5 Chronic Kidney Disease | Planned for Zemplar administration due to secondary hyperparathyroidism |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 6 months |
| Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded. | 6 months |
| Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded. | 6 months |
| Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded. | 6 months |
| Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study | The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded. | 6 months |
| Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded. | 6 months |
| Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination | The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks. | 6 months |
| Cheboksary |
| 428018 |
| Russia |
| Site Reference ID/Investigator# 58347 | Chelyabinsk | 454076 | Russia |
| Site Reference ID/Investigator# 67404 | Iakutsk | 677019 | Russia |
| Site Reference ID/Investigator# 57344 | Irkutsk | 664079 RF | Russia |
| Site Reference ID/Investigator# 57346 | Kazan' | 420045 | Russia |
| Site Reference ID/Investigator# 58356 | Moscow | 125284 | Russia |
| Site Reference ID/Investigator# 58348 | Moscow | 127015 | Russia |
| Site Reference ID/Investigator# 57342 | Novosibirsk | 630120 | Russia |
| Site Reference ID/Investigator# 57364 | Orenburg | 460040 | Russia |
| Site Reference ID/Investigator# 57363 | Saint Petersburg | 191104 | Russia |
| Site Reference ID/Investigator# 69687 | Samara | 443095 | Russia |
| Site Reference ID/Investigator# 69688 | Ulan-Ude | 670031 | Russia |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Stage 5 Chronic Kidney Disease | Planned for Zemplar administration due to secondary hyperparathyroidism |
| 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, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | Participants |
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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 | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Percentage of Participants Who Reached a Target Level of Intact Parathyroid Hormone (iPTH) (150-300 pg/mL) Post-baseline at Least Once During the Study | The percentage of participants who had a post-baseline intact parathyroid hormone (iPTH) level in the range of 150 to 300 pg/mL at least once during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| Secondary | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Least Once During the Study | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as achievement of iPTH level 2 to 9 times the upper limit of normal) at least once during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Reached the Kidney Disease Improving Global Outcomes Target Level of Intact Parathyroid Hormone (iPTH) at Each Visit During the Study | The percentage of participants who reached the Kidney Disease Improving Global Outcomes target level of intact parathyroid hormone (iPTH) (defined as the achievement of iPTH level 2 to 9 times the upper limit of normal) at each visit during the study was recorded. | The analysis for this outcome was based on the number of participants (55) who completed the study. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| Secondary | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Least Once Post-baseline During the Study | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at least once post-baseline during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Elevated Calcium (Ca) x Phosphate (P) (> 75 mg˄2/dL˄2) Levels at Each Visit Post-baseline During the Study | The percentage of participants who developed elevated calcium (Ca) x phosphate (P) (> 75 mg˄2/dL˄2) levels at each visit post-baseline during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Least Once Post-baseline During the Study | The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at least once post-baseline during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
|
| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Elevated Normalized Total Calcium (> 11.2 mg/dL) at Each Visit Post-baseline During the Study | The percentage of participants who developed elevated normalized total calcium (> 11.2 mg/dL) at each visit post-baseline during the study was recorded. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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| |||||||||||||||||||||||||||
| Secondary | Percentage of Participants Who Developed Hypercalcemia and Hyperphosphatemia Leading to Study Termination | The percentage of participants who developed hypercalcemia (too much calcium in the blood) and hyperphosphatemia (too much phosphate in the blood) leading to study termination was recorded. Hypercalcemia was defined as calcium level greater than 11.2 mg/dL for more than 8 weeks, and hyperphosphatemia was defined as phosphate level greater than 6.5 mg/dL for more than 8 weeks. | Posted | Number | 95% Confidence Interval | Percentage of participants | 6 months |
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Adverse events were collected from the time of study drug administration until 30 days or five half-lives following discontinuation of study drug. In addition, SAEs were collected from the time the participant signed the informed consent.
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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 | Stage 5 Chronic Kidney Disease | Planned for Zemplar administration due to secondary hyperparathyroidism | 3 | 86 | 6 | 86 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Circulatory collapse | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Post procedural hematoma | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Restless legs syndrome | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Non-systematic Assessment |
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| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 15.0 | Non-systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Non-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 |
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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