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Prospective, non-randomized, multi-center study to assess the efficacy and safety of paricalcitol injection or oral administered over 6 months to patients with secondary hyperparathyroidism on dialysis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol injection | Active Comparator | ABT-358 Zemplar |
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| Paricalcitol capsules | Active Comparator | ABT-358 Zemplar |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol injection | Drug | Most recent iPTH level in pg/mL divided by 100 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly |
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level. | 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75. | 24 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jose-Luis Cañadas, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Ref # / Investigator 19391 | Jojutla Morelos | CP 62900 | Mexico | |||
| Site Ref # / Investigator 19392 |
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Participants were enrolled into the study at 12 dialysis centers in Mexico. Recruitment began in September 2007 and ended in January 2010. The study population consisted of patients on hemodialysis or peritoneal dialysis with a diagnosis of secondary hyperparathyroidism.
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| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol Injection | Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis. |
| FG001 | Paricalcitol Capsules | Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Paricalcitol capsules | Drug | Most recent iPTH level in pg/mL divided by 80 = dose in mcg; dose is rounded down to nearest mcg and administered 3x weekly |
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| Proportion of Subjects Who Achieve an iPTH <300 pg/mL | Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL. | 24 weeks |
| Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%. | 24 weeks |
| Duration of Response to Treatment | Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit. | 24 weeks |
| Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules. | Baseline and 24 weeks |
| Mexico City |
| CP 01030 |
| Mexico |
| Site Ref # / Investigator 19397 | Mexico City | CP 02080 | Mexico |
| Site Ref # / Investigator 19396 | Mexico City | CP 03650 | Mexico |
| Site Ref # / Investigator 19389 | Mexico City | CP 03900 | Mexico |
| Site Ref # / Investigator 19390 | Mexico City | CP 14000 | Mexico |
| Site Ref # / Investigator 19393 | Mexico City | CP 14080 | Mexico |
| Site Ref # / Investigator 19394 | Mexico City | CP 14140 | Mexico |
| Site Ref # / Investigator 19395 | Mexico City | CP 16070 | Mexico |
| Site Ref # / Investigator 19399 | Puebla City | CP 72400 | Mexico |
| Site Ref # / Investigator 19398 | Zapopan | CP 45116 | Mexico |
| Site Ref # / Investigator 19388 | Zapopan | CP 45150 | Mexico |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol Injection | Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis. |
| BG001 | Paricalcitol Capsules | Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis. |
| 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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| 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 | Proportion of Subjects Who Achieve at Least a 50% Reduction in iPTH Compared to Baseline Level | Number of participants who achieved at least a 50% reduction in intact parathyroid hormone (iPTH) compared to the baseline level. | The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol. | Posted | Number | participants | 24 weeks |
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| Secondary | Analysis of Episodes of Hypercalcemia (> 11.5 mg/dL), Hyperphosphatemia (> 7.0 mg/dL) and Elevations of Calcium x Phosphorus Product (> 75) | Number of participants with hypercalcemia (calcium levels greater than 11.5 mg/dL), hyperphosphatemia (phosphorus levels greater than 7.0 mg/dL), or calcium x phosphorus product levels greater than 75. | The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol. | Posted | Number | participants | 24 Weeks |
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| Secondary | Proportion of Subjects Who Achieve an iPTH <300 pg/mL | Number of participants who achieved an intact parathyroid hormone (iPTH) level of less than 300 pg/mL. | The analysis was intention to treat (ITT). The ITT population was defined as all participants who fulfilled inclusion criteria and received at least one dose of paricalcitol. | Posted | Number | participants | 24 weeks |
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| Secondary | Time Required to Achieve: (1) a Reduction in iPTH Less Than <300 pg/mL;(2) a 50% Reduction in iPTH Compared to the Baseline Level; and (3) Either a Reduction in iPTH Less Than <300 pg/mL or a 50% Reduction in iPTH Compared to the Baseline Level | Number of days required to achieve a reduction in intact parathyroid hormone (iPTH) to less than 300 pg/mL, a reduction in iPTH of greater than or equal to 50%, or either a reduction in iPTH to less than 300 pg/mL or a reduction in iPTH of greater than or equal to 50%. | The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants. | Posted | Mean | Standard Deviation | days | 24 weeks |
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| Secondary | Duration of Response to Treatment | Time in days between 2 consecutive visits with a reduction in intact parathyroid hormone (iPTH) of greater than or equal to 50% from the baseline visit. | The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants. | Posted | Mean | Standard Deviation | days | 24 weeks |
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| Secondary | Health-related Quality of Life With Paricalcitol Injection or Oral Treatment | Analysis of the differences before and after 24 weeks of treatment in various quality of life measurements for participants on hemodialysis receiving paricalcitol injection and participants on peritoneal dialysis receiving paricalcitol capsules. | The analysis was per protocol. The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. The per-protocol population included 121 participants. | Posted | Number | Participants | Baseline and 24 weeks |
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From date of first dose of study drug through 30 days after the last dose of study drug.
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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 | Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis. | 8 | 38 | 25 | 38 | ||
| EG001 | Paricalcitol Capsules | Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis. | 9 | 109 | 84 | 109 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hernia | Gastrointestinal disorders | MedDRA 13.0 |
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| Peritonitis | Infections and infestations | MedDRA 13.0 |
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| Pneumonia | Infections and infestations | MedDRA 13.0 |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Headache | Nervous system disorders | MedDRA 13.0 |
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| Convulsion | Nervous system disorders | MedDRA 13.0 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Indwelling catheter management | Surgical and medical procedures | MedDRA 13.0 |
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| Hypertension | Vascular disorders | MedDRA 13.0 |
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| Hypotension | Vascular disorders | MedDRA 13.0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Leukocytosis | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Eosinophilia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA 13.0 |
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| Tachycardia paroxysmal | Cardiac disorders | MedDRA 13.0 |
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| Extrasystoles | Cardiac disorders | MedDRA 13.0 |
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| Supraventricular tachycardia | Cardiac disorders | MedDRA 13.0 |
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| Angina pectoris | Cardiac disorders | MedDRA 13.0 |
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| Hyperparathyroidism | Endocrine disorders | MedDRA 13.0 |
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| Hypoparathyroidism | Endocrine disorders | MedDRA 13.0 |
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| Hypothyroidism | Endocrine disorders | MedDRA 13.0 |
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| Ocular hyperaemia | Eye disorders | MedDRA 13.0 |
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| Vision blurred | Eye disorders | MedDRA 13.0 |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 13.0 |
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| Constipation | Gastrointestinal disorders | MedDRA 13.0 |
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| Gastritis | Gastrointestinal disorders | MedDRA 13.0 |
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| Vomiting | Gastrointestinal disorders | MedDRA 13.0 |
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| Gingivitis | Gastrointestinal disorders | MedDRA 13.0 |
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| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 13.0 |
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| Nausea | Gastrointestinal disorders | MedDRA 13.0 |
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| Pyrexia | General disorders | MedDRA 13.0 |
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| Fatigue | General disorders | MedDRA 13.0 |
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| Chest pain | General disorders | MedDRA 13.0 |
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| Headache | General disorders | MedDRA 13.0 |
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| Hepatitis | Hepatobiliary disorders | MedDRA 13.0 |
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| Hyperbilirubinaemia | Hepatobiliary disorders | MedDRA 13.0 |
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| Upper respiratory tract infection | Infections and infestations | MedDRA 13.0 |
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| Ear infection | Infections and infestations | MedDRA 13.0 |
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| Catheter site infection | Infections and infestations | MedDRA 13.0 |
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| Peritonitis | Infections and infestations | MedDRA 13.0 |
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| Herpes zoster | Infections and infestations | MedDRA 13.0 |
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| Unevaluable event | Infections and infestations | MedDRA 13.0 |
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| Dengue fever | Infections and infestations | MedDRA 13.0 |
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| Urinary tract infection | Infections and infestations | MedDRA 13.0 |
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| Onychomycosis | Infections and infestations | MedDRA 13.0 |
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| Incisional hernia | Injury, poisoning and procedural complications | MedDRA 13.0 |
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| Phlebitis | Injury, poisoning and procedural complications | MedDRA 13.0 |
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| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Hypokalaemia | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Oedema | Metabolism and nutrition disorders | MedDRA 13.0 |
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| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Joint dislocation | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 13.0 |
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| Dizziness | Nervous system disorders | MedDRA 13.0 |
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| Insomnia | Psychiatric disorders | MedDRA 13.0 |
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| Depression | Psychiatric disorders | MedDRA 13.0 |
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| Anxiety | Psychiatric disorders | MedDRA 13.0 |
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| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Pleurisy | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Bronchospasm | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Acne | Skin and subcutaneous tissue disorders | MedDRA 13.0 |
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| Indwelling catheter management | Surgical and medical procedures | MedDRA 13.0 |
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| Hypertension | Vascular disorders | MedDRA 13.0 |
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| Hypotension | Vascular disorders | MedDRA 13.0 |
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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 |
| D006961 | Hyperparathyroidism |
| ID | Term |
|---|---|
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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