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The purpose of this study is to observe the effectiveness and safety of the use of a low initial dose regime (iPTH/100) in chronic kidney disease patients with secondary hyperparathyroidism (PTH>300pg/mL) and that require dialysis at least 3 times per week.
The study will be carried out in three dialysis centers in Peru. Each patient enrolled in the study will be followed during a 6 month period from the time of inclusion. Study visits will occur at Baseline and at Weeks 4, 8, 12 and 24 during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zemplar (paracalcitol) | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zemplar (paricalcitol) | Drug | Zemplar (paricalcitol) dose will be calculated mcg=PARATHYROID HORMONE level/100; this will be provided 3 times per week. Dose will be adjusted by 2-4 mcg every 4 weeks according to the parathyroid hormone level. |
| Measure | Description | Time Frame |
|---|---|---|
| The Percentage of Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL | The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL | Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL. | 24 Weeks |
| Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Oscar E Guerra, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 21401 | Callao | CALLAO 2 | Peru | |||
| Site Reference ID/Investigator# 23857 |
A total of 114 participants were screened. Of those, 100 participants were enrolled and received at least one dose of study drug.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol Injection | Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study. |
| 24 Weeks |
| Lima |
| Lima-11 |
| Peru |
| Site Reference ID/Investigator# 10941 | Lima | Peru |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol Injection | Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| 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 Patients Reaching at Least a 30% Reduction in PTH and/or Values in Range 150-300 pg/mL | The percentage of participants who achieved at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150 to 300 picograms per milliliter (pg/mL) at any post-baseline visit during the study. An iPTH value of 150-300 pg/ml is the target range recommended by the NKF KDOQI (National Kidney Foundation Kidney Disease Outcomes Quality Initiative) for End Stage Renal Disease patients. | Analysis is based on the number of participants completing the study. | Posted | Number | Percentage of participants | 24 weeks |
|
|
| ||||||||||||||||||||||||||
| Secondary | Time to Reach the First 30% Reduction in PTH and/or a Value Between 150-300pg/mL | Median time to achieve at least a 30% reduction in intact parathyroid hormone (iPTH) and/or an iPTH value in the range of 150-300 pg/mL. | Posted | Median | Inter-Quartile Range | Weeks | 24 Weeks |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Hypercalcemia (>10.5mg/dL), Hyperphosphatemia (>6.5mg/dL) and/or Elevations of the Ca X P Product (>65). | The number of participants with hypercalcemia (defined as at least one calcium value of more than 10.5 milligrams per deciliter [mg/dL]), hyperphosphatemia (phosphorus value of more than 6.5 mg/dL), and/or elevation of Calcium X Phosphorus product (value greater than 65) during the 24 week study. | Posted | Number | Number of participants | 24 Weeks |
|
|
Baseline through 24 weeks.
The investigators monitored each participant for clinical and laboratory evidence of adverse events on a routine basis throughout the study. All serious and non serious adverse events from the time participant received the first dose of study drug until one month after the last dose of paricalcitol were reported.
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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 Injection | Initial dosage was calculated based on intact parathyroid hormone (iPTH) as follows: iPTH level/100 = micrograms (mcg) dose. Drug was administered 3 times per week. Dosage could be adjusted by 2 to 4 mcg every 4 weeks based on the participant's iPTH, calcium and phosphorus levels. | 15 | 100 | 47 | 100 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute coronary syndrome | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Upper gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 14.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Systematic Assessment |
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| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Systematic Assessment |
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| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypercalcemia | Metabolism and nutrition disorders | MedDRA 14.0 | Systematic Assessment |
| |
| Hyperphosphatemia | Metabolism and nutrition disorders | MedDRA 14.0 | 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 | 1-800-633-9110 |
| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D051436 | Renal Insufficiency, Chronic |
| D006934 | Hypercalcemia |
| 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 |
| D002128 | Calcium Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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