Trial Outcomes & Findings for Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis (NCT NCT01084538)
NCT ID: NCT01084538
Last Updated: 2011-09-21
Results Overview
Recruitment status
COMPLETED
Target enrollment
181 participants
Primary outcome timeframe
Baseline through 12 months
Results posted on
2011-09-21
Participant Flow
Safety population consists of 181 participants who received at least one dose of drug. Of those, 175 were included in the full analysis set. Six participants were excluded; five due to initial intact parathyroid hormone values less than 300 picograms per milliliter and one suffered a serious adverse event before the first evaluation (study visit).
Participant milestones
| Measure |
End Stage Chronic Kidney Disease
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Overall Study
STARTED
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181
|
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Overall Study
COMPLETED
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113
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Overall Study
NOT COMPLETED
|
68
|
Reasons for withdrawal
| Measure |
End Stage Chronic Kidney Disease
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Overall Study
Drug not available
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30
|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Kidney transplant
|
6
|
|
Overall Study
Serious Adverse Event
|
3
|
|
Overall Study
Lack of effectiveness
|
2
|
|
Overall Study
Patient noncompliance
|
2
|
|
Overall Study
Hyperphosphatemia
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2
|
|
Overall Study
Nodular hyperplasia of parathyroid gland
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2
|
|
Overall Study
Change of residence
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2
|
|
Overall Study
Over-suppression of parathyroid gland
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2
|
|
Overall Study
Reason unknown
|
8
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Baseline Characteristics
Study of Zemplar iv in Patients With End Stage Chronic Kidney Disease, Undergoing Haemodialysis
Baseline characteristics by cohort
| Measure |
End Stage Chronic Kidney Disease
n=175 Participants
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Age Continuous
|
55.3 years
STANDARD_DEVIATION 12.9 • n=99 Participants
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Sex: Female, Male
Female
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79 Participants
n=99 Participants
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Sex: Female, Male
Male
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96 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Baseline through 12 monthsPopulation: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
Outcome measures
| Measure |
End Stage Chronic Kidney Disease
n=174 Participants
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Percentage of Subjects Achieving at Least a 40% Reduction of iPTH (Intact Parathyroid Hormone) From Baseline
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58.1 percentage of participants
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SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
Percentage of subjects achieving a serum iPTH level less than or equal to 300 pg/mL on the final visit.
Outcome measures
| Measure |
End Stage Chronic Kidney Disease
n=174 Participants
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Percentage of Subjects Achieving Serum iPTH Level Less Than or Equal to 300 Picograms Per Milliliter (pg/mL)
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43.7 percentage of participants
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SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: Of the 175 participants in the full analysis set, one participant was excluded from the analysis due to missing data.
The average time (measured in days) to achieve target iPTH levels.
Outcome measures
| Measure |
End Stage Chronic Kidney Disease
n=174 Participants
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Time (Measured in Days) to Achieve Intact Parathyroid Hormone (iPTH) Levels Less Than or Equal to 300 pg/mL
|
107.0 Days
Standard Deviation 102.7
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SECONDARY outcome
Timeframe: Baseline through 12 monthsPopulation: Analysis was based on the number of subjects included in the full analysis set (N=175).
Number of participants with clinically meaningful hypercalcemia, defined as corrected serum calcium greater than 11.0 milligrams per deciLiter (mg/dL) taken at two consecutive measurements (visits) during the study.
Outcome measures
| Measure |
End Stage Chronic Kidney Disease
n=175 Participants
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Clinically Meaningful Hypercalcemia, Defined as Corrected Serum Calcium Greater Than 11.0 Milligrams Per deciLiter (mg/dL) Taken at Two Consecutive Measurements.
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2 participants
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Adverse Events
End Stage Chronic Kidney Disease
Serious events: 15 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
End Stage Chronic Kidney Disease
n=181 participants at risk
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
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|---|---|
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Nervous system disorders
Paresis
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Nervous system disorders
Spinal cord neoplasm
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
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General disorders
Death
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumonia
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
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Respiratory, thoracic and mediastinal disorders
Cancer of lung
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
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Vascular disorders
Pulmonary embolism
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Vascular disorders
Radial artery embolism
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Vascular disorders
Thrombosis arteriovenous fistula
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Gastrointestinal disorders
Gastritis chronic
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Cardiac disorders
Cardiopulmonary arrest
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Cardiac disorders
Hypertension
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Cardiac disorders
Myocardial Infarction
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Cardiac disorders
Pericardial effusion
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1.1%
2/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Cardiac disorders
Pulmonary edema
|
0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Endocrine disorders
Parathyroid adenoma
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0.55%
1/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Nervous system disorders
Cerebrovascular accident
|
1.1%
2/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
Other adverse events
| Measure |
End Stage Chronic Kidney Disease
n=181 participants at risk
Participants receiving hemodialysis for end stage chronic kidney disease in whom a diagnosis of secondary hyperparathyroidism (defined as intact parathyroid hormone \[iPTH\] less than 300 picograms per milliliter \[pg/mL\]) has been established. Zemplar (paricalcitol) injection was to be prescribed in the usual manner in accordance with the terms of the local Summary of Product Characteristics.
|
|---|---|
|
Endocrine disorders
Hypercalcemia
|
7.2%
13/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
|
|
Endocrine disorders
Hyperphosphaetemia
|
8.8%
16/181 • Study start for up to 12 months (end of study). All serious adverse events were reported from the time the physician obtained the patient's authorization to use and disclose information (informed consent).
Serious adverse events were assessed at each study visit. Adverse events with an onset date on or after the day of first dose and up to 30 days after the last dose of Zemplar (paricalcitol) therapy were summarized.
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Additional Information
Global Medical Services
Abbott
Phone: 1-800-633-9110
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER