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| ID | Type | Description | Link |
|---|---|---|---|
| To Target |
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The purpose of this study is to show that the use of cinacalcet in patients with End Stage Renal Disease can help achieve NKF K/DOQI targets for both serum calcium and calcium phosphorous product.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cinacalcet | Experimental | Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL) unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cinacalcet | Drug | Cinacalcet tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 | The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. | Weeks 17 to 23 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL | Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase. | Weeks 17 to 23 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
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| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
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Participants were enrolled from 27 October 2006 through 31 December 2008
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| ID | Title | Description |
|---|---|---|
| FG000 | Cinacalcet | Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) |
The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels. |
| Weeks 17 to 23 |
| Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L | The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase. | Weeks 17 to 23 |
| Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L | The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase. | Weeks 17 to 23 |
| Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL | The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase. | Weeks 17 to 23 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cinacalcet | Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. |
| 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 |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 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 | Number of Participants With a Mean Intact Parathyroid Hormone Value Between 150 and 300 pg/mL and a Calcium - Phosphorus Product Value < 55 mg^2/dL^2 | The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF K/DOQI) recommends that treatment interventions to control parathyroid hormone should not result in significant elevation of calcium - phosphorus product (Ca x P; a derived value calculated from serum calcium and phosphorus levels). The primary objective of the study was to assess the simultaneous achievement of NKF K/DOQI targets of intact parathyroid hormone (iPTH) greater than or equal to 15.9 pmol/L and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) and a Ca x P value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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| Secondary | Number of Participants Who Achieved a Mean iPTH Value Between 150 and 300 pg/mL | Number of participants who achieved a mean intact Parathyroid Hormone (iPTH) value greater than or equal to 15.9 and less than or equal to 31.8 pmol/L (150 - 300 pg/mL) during the effectiveness assessment phase. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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| Secondary | Number of Participants Who Achieved a Mean Ca x P Value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) | The number of participants who achieved a mean serum calcium x phosphorus (Ca x P) value < 4.44 mmol^2/L^2 (55 mg^2/dL^2) during the effectiveness assessment phase. The calcium - phosphorus product is a derived value calculated from serum calcium and phosphorus levels. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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| Secondary | Number of Participants Who Achieved a Mean Calcium Value ≥ 2.1 and ≤ 2.37 mmol/L | The number of participants who achieved a mean corrected serum calcium (Ca) value ≥ 2.1 and ≤ 2.37 mmol/L (8.4 to 9.5 mg/dL) during the effectiveness assessment phase. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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| Secondary | Number of Participants Who Achieved a Mean Phosphorus Value ≥ 1.13 and ≤ 1.78 mmol/L | The number of participants who achieved a mean serum phosphorus value ≥ 1.13 and ≤ 1.78 mmol/L (3.5 to 5.5 mg/dL) during the effectiveness assessment phase. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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| Secondary | Number of Participants Who Achieved a Mean CRP < 0.6 mg/dL | The number of participants who achieved a mean C-reactive protein (CRP) level of < 0.6 mg/dL during the effectiveness assessment phase. | All participants who received cinacalcet | Posted | Number | Participants | Weeks 17 to 23 |
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23 weeks
The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
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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 | Cinacalcet | Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. | 27 | 71 | 42 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Coronary Syndrome | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA 9.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Pancreatitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Peritonitis | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Umbilical Hernia | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Jaundice | Hepatobiliary disorders | MedDRA 9.0 | Systematic Assessment |
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| Appendicitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Arteriovenous Fistula Site Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Bacteraemia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Ross River Virus Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Sepsis | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Arteriovenous Fistula Site Complication | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Arteriovenous Fistula Thrombosis | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Complications of Transplanted Kidney | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Thrombosis in Device | Injury, poisoning and procedural complications | MedDRA 9.0 | Systematic Assessment |
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| Blood Test Abnormal | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Platelet Count Decreased | Investigations | MedDRA 9.0 | Systematic Assessment |
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| Dehydration | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Hepatic Neoplasm Malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 9.0 | Systematic Assessment |
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| Renal Colic | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Renal Failure Chronic | Renal and urinary disorders | MedDRA 9.0 | Systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Skin Lesion | Skin and subcutaneous tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Arteriovenous Fistula Operation | Surgical and medical procedures | MedDRA 9.0 | Systematic Assessment |
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| Hypertension | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Iliac Artery Stenosis | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Necrosis Ischaemic | Vascular disorders | MedDRA 9.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 9.0 | Systematic Assessment |
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| Chest Pain | General disorders | MedDRA 9.0 | Systematic Assessment |
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| Lower Respiratory Tract Infection | Infections and infestations | MedDRA 9.0 | Systematic Assessment |
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| Anorexia | Metabolism and nutrition disorders | MedDRA 9.0 | Systematic Assessment |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Pain in Extremity | Musculoskeletal and connective tissue disorders | MedDRA 9.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 9.0 | Systematic Assessment |
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The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Amgen Inc. | 866-572-6436 |
| ID | Term |
|---|---|
| D000740 | Anemia |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
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| Black or African American |
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| Native Hawaiian or Other Pacific Islander |
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| White or Caucasian |
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| Other |
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