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| ID | Type | Description | Link |
|---|---|---|---|
| 2009-011378-14 | EudraCT Number |
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Evaluates the effectiveness of on-label Paricalcitol versus Cinacalcet with Low-Dose Vitamin D.
During a 4-week washout period, participants stopped taking cinacalcet or other vitamin D receptor activators (VDRAs). (Participants who were naive to cinacalcet or VDRAs did not have to wash out). At randomization, participants entered a 28-week open-label treatment period, during which they received either cinacalcet or paricalcitol. Participants who were assigned to receive paricalcitol were dosed according to the approved label in their respective geographic regions (i.e., IV at sites in the US and Russia and oral at sites in Europe). Supplemental cinacalcet was administered to participants in the paricalcitol arms who developed hypercalcemia (defined as >= 10.5 mg/dL). The evaluation period was from Weeks 21 to 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IV Paricalcitol | Active Comparator | Participants in the IV stratum received intravenous (IV) paricalcitol and, if hypercalcemia (calcium >= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at 0.07 mcg/kg with titration every 2 weeks. |
|
| Cinacalcet (at sites with IV paricalcitol) | Active Comparator | Participants in the IV stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (doxercalciferol IV 1 mcg 3 times weekly (TIW) at sites in the US and alfacalcidol capsules 0.25 mcg daily at sites in Russia). |
|
| Oral paricalcitol | Active Comparator | Participants in the oral stratum received oral paricalcitol and, if hypercalcemia (calcium >= 10.5 mg/dL), received 30 mg of oral cinacalcet. Paricalcitol was dosed at mcg = IPTH/60 3 times weekly (TIW) with titration every 2 weeks. |
|
| Cinacalcet (at sites with oral paricalcitol) | Active Comparator | Participants in the oral stratum received 30 mg of oral cinacalcet daily with a low-dose vitamin D receptor activator (VDRA) (alfacalcidol capsules 0.25 mcg daily). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Paricalcitol dosed per label by region (participants were to receive cinacalcet if they developed hypercalcemia) |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. | Weeks 21 to 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted. |
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Inclusion Criteria
Male or female patients >= 18 years old.
Patient was diagnosed with Stage 5 chronic kidney disease (CKD) and had been receiving intravenous (IV) or oral vitamin D receptor activators (VDRAs) or cinacalcet during the 8 weeks prior to the screening period or naïve patients who had not received VDRA or cinacalcet within 8 weeks of screening.
Patient was on maintenance HD (hemodialysis) 3 times weekly (TIW) for at least 3 months prior to screening and was expected to remain on HD for the duration of the study.
For entry into the Pre-Treatment Washout Period (for patients who were not naïve to VDRAs and cinacalcet), the patient had to have screening laboratory values of:
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Samina Khan, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 22781 | Tempe | Arizona | 85284 | United States | ||
| Site Reference ID/Investigator# 24342 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24500308 | Derived | Cozzolino M, Ketteler M, Martin KJ, Sharma A, Goldsmith D, Khan S. Paricalcitol- or cinacalcet-centred therapy affects markers of bone mineral disease in patients with secondary hyperparathyroidism receiving haemodialysis: results of the IMPACT-SHPT study. Nephrol Dial Transplant. 2014 Apr;29(4):899-905. doi: 10.1093/ndt/gfu011. Epub 2014 Feb 4. | |
| 24214232 |
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Of the 272 participants enrolled in the study, 4 did not receive study drug and were not included in the population analyzed.
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| ID | Title | Description |
|---|---|---|
| FG000 | IV Paricalcitol in the IV Stratum | IV stratum |
| FG001 | Cinacalcet in the IV Stratum | IV stratum |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
| Cinacalcet | Drug | On-label oral cinacalcet by region with low dose vitamin D receptor activator (VDRA) (either doxercalciferol at US sites or alfacalcidol at non-US sites) |
|
|
| Weeks 21 to 28 |
| Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted. | Weeks 21 to 28 |
| Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together. | Weeks 21 to 28 |
| Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) | Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted. | Weeks 21 to 28 |
| Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) | Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted. | Weeks 21 to 28 |
| Chula Vista |
| California |
| 91910 |
| United States |
| Site Reference ID/Investigator# 21142 | Los Angeles | California | 90033 | United States |
| Site Reference ID/Investigator# 22762 | Los Angeles | California | 90048 | United States |
| Site Reference ID/Investigator# 22758 | Riverside | California | 92505 | United States |
| Site Reference ID/Investigator# 21442 | San Diego | California | 92123 | United States |
| Site Reference ID/Investigator# 23688 | Arvada | Colorado | 80002 | United States |
| Site Reference ID/Investigator# 21370 | Coral Springs | Florida | 33071 | United States |
| Site Reference ID/Investigator# 25902 | Hudson | Florida | 34667 | United States |
| Site Reference ID/Investigator# 21146 | Lauderdale Lakes | Florida | 33313 | United States |
| Site Reference ID/Investigator# 26743 | Lauderdale Lakes | Florida | 33313 | United States |
| Site Reference ID/Investigator# 22788 | Miami | Florida | 33173 | United States |
| Site Reference ID/Investigator# 22722 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 23147 | Tampa | Florida | 33614 | United States |
| Site Reference ID/Investigator# 22778 | Meridian | Idaho | 83642 | United States |
| Site Reference ID/Investigator# 21369 | Detroit | Michigan | 48202 | United States |
| Site Reference ID/Investigator# 22786 | Detroit | Michigan | 48236 | United States |
| Site Reference ID/Investigator# 21144 | St Louis | Missouri | 63110 | United States |
| Site Reference ID/Investigator# 21443 | St Louis | Missouri | 63110 | United States |
| Site Reference ID/Investigator# 21145 | Omaha | Nebraska | 68131 | United States |
| Site Reference ID/Investigator# 22505 | Flushing | New York | 11355 | United States |
| Site Reference ID/Investigator# 22759 | Toledo | Ohio | 43606 | United States |
| Site Reference ID/Investigator# 22796 | Lancaster | Pennsylvania | 17604 | United States |
| Site Reference ID/Investigator# 22770 | Philadelphia | Pennsylvania | 19106 | United States |
| Site Reference ID/Investigator# 22772 | Aiken | South Carolina | 29801 | United States |
| Site Reference ID/Investigator# 21147 | Orangeburg | South Carolina | 29115 | United States |
| Site Reference ID/Investigator# 22982 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 21143 | Houston | Texas | 77099 | United States |
| Site Reference ID/Investigator# 22506 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 22776 | Bluefield | West Virginia | 24701 | United States |
| Site Reference ID/Investigator# 22311 | Brno | 65691 | Czechia |
| Site Reference ID/Investigator# 22310 | Jilemnice | 51415 | Czechia |
| Site Reference ID/Investigator# 21624 | Ústà nad Labem | 40113 | Czechia |
| Site Reference ID/Investigator# 22363 | Aalborg | 9000 | Denmark |
| Site Reference ID/Investigator# 23105 | Copenhagen | 2100 | Denmark |
| Site Reference ID/Investigator# 23909 | Fredericia | 7000 | Denmark |
| Site Reference ID/Investigator# 22462 | Holstebro | 7500 | Denmark |
| Site Reference ID/Investigator# 21748 | Coburg | 96450 | Germany |
| Site Reference ID/Investigator# 33268 | Darmstadt | 64295 | Germany |
| Site Reference ID/Investigator# 35903 | Düsseldorf | 40210 | Germany |
| Site Reference ID/Investigator# 21742 | Frankfurt | 60590 | Germany |
| Site Reference ID/Investigator# 21744 | Heilbronn | 74076 | Germany |
| Site Reference ID/Investigator# 21368 | Lüdenscheid | 58515 | Germany |
| Site Reference ID/Investigator# 22362 | Athens | 11528 | Greece |
| Site Reference ID/Investigator# 38970 | Thessaloniki | 546 36 | Greece |
| Site Reference ID/Investigator# 22322 | Thessaloniki | 54636 | Greece |
| Site Reference ID/Investigator# 22463 | Thessaloniki | 54642 | Greece |
| Site Reference ID/Investigator# 22323 | Thessaloniki | 56403 | Greece |
| Site Reference ID/Investigator# 39262 | Thessaloniki | 570 01 | Greece |
| Site Reference ID/Investigator# 22312 | Bergamo | 24128 | Italy |
| Site Reference ID/Investigator# 21746 | Genova | 16132 | Italy |
| Site Reference ID/Investigator# 39180 | Lucca | 55100 | Italy |
| Site Reference ID/Investigator# 22314 | Milan | 20122 | Italy |
| Site Reference ID/Investigator# 21367 | Pavia | 27100 | Italy |
| Site Reference ID/Investigator# 21745 | Pesaro | 61100 | Italy |
| Site Reference ID/Investigator# 21842 | Alkmaar | 1815 JD | Netherlands |
| Site Reference ID/Investigator# 22309 | Delft | 2625 AD | Netherlands |
| Site Reference ID/Investigator# 21843 | Dordrecht | 3317 NM | Netherlands |
| Site Reference ID/Investigator# 38903 | Beja | 7800-309 | Portugal |
| Site Reference ID/Investigator# 38531 | Faro | 8005- 546 | Portugal |
| Site Reference ID/Investigator# 22464 | Lisbon | 1750-130 | Portugal |
| Site Reference ID/Investigator# 23910 | Vila Franca de Xira | 2600-076 | Portugal |
| Site Reference ID/Investigator# 24643 | Moscow | 123182 | Russia |
| Site Reference ID/Investigator# 24642 | Moscow | 125284 | Russia |
| Site Reference ID/Investigator# 21361 | Barcelona | 08025 | Spain |
| Site Reference ID/Investigator# 21364 | Córdoba | 14004 | Spain |
| Site Reference ID/Investigator# 22366 | L'Hospitalet, Barcelona | 08097 | Spain |
| Site Reference ID/Investigator# 38343 | Madrid | 28040 | Spain |
| Site Reference ID/Investigator# 21362 | Madrid | 28041 | Spain |
| Site Reference ID/Investigator# 21363 | Palma de Mallorca | 07014 | Spain |
| Site Reference ID/Investigator# 22367 | Pamplona | 31008 | Spain |
| Site Reference ID/Investigator# 38462 | Puerto de la Cruz | 38400 | Spain |
| Site Reference ID/Investigator# 21365 | Seville | 41007 | Spain |
| Site Reference ID/Investigator# 23913 | Linköping | 58185 | Sweden |
| Site Reference ID/Investigator# 23782 | Stockholm | 182 88 | Sweden |
| Site Reference ID/Investigator# 22364 | Uppsala | 751 85 | Sweden |
| Site Reference ID/Investigator# 23912 | Birmingham | B18 7QH | United Kingdom |
| Site Reference ID/Investigator# 21747 | Coventry | CV2 2DX | United Kingdom |
| Site Reference ID/Investigator# 23102 | London | NW3 2PF | United Kingdom |
| Site Reference ID/Investigator# 23104 | London | SE1 9RT | United Kingdom |
| Site Reference ID/Investigator# 23103 | Manchester | M6 8HD | United Kingdom |
| Site Reference ID/Investigator# 41982 | Omagh, Northern Ireland | BT79 0AP | United Kingdom |
| Site Reference ID/Investigator# 40222 | Sheffield | S5 7AU | United Kingdom |
| Sharma A, Marshall TS, Khan SS, Johns B. Cost effectiveness of paricalcitol versus cinacalcet with low-dose vitamin D for management of secondary hyperparathyroidism in haemodialysis patients in the USA. Clin Drug Investig. 2014 Feb;34(2):107-15. doi: 10.1007/s40261-013-0151-4. |
| 22387567 | Derived | Ketteler M, Martin KJ, Wolf M, Amdahl M, Cozzolino M, Goldsmith D, Sharma A, Marx S, Khan S. Paricalcitol versus cinacalcet plus low-dose vitamin D therapy for the treatment of secondary hyperparathyroidism in patients receiving haemodialysis: results of the IMPACT SHPT study. Nephrol Dial Transplant. 2012 Aug;27(8):3270-8. doi: 10.1093/ndt/gfs018. Epub 2012 Mar 2. |
| FG002 |
| Oral Paricalcitol in the Oral Stratum |
Oral stratum |
| FG003 | Cinacalcet in the Oral Stratum | Oral stratum |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | IV Paricalcitol in the IV Stratum | IV stratum |
| BG001 | Cinacalcet in the IV Stratum | IV stratum |
| BG002 | Oral Paricalcitol in the Oral Stratum | Oral stratum |
| BG003 | Cinacalcet in the Oral Stratum | Oral stratum |
| BG004 | Total | Total of all reporting groups |
| 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 |
| ||||||||||||||||
| History of type 1 diabetes mellitus | Number | Participants |
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| History of type 2 diabetes mellitus | Number | Participants |
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| History of angina | Number | Participants |
| ||||||||||||||||
| History of coronary artery disease | Number | Participants |
| ||||||||||||||||
| History of left ventricular hypertrophy | Number | Participants |
| ||||||||||||||||
| History of myocardial infarction | Number | Participants |
|
| 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 Number of Participants Who Achieve a Mean Intact Parathyroid Hormone (iPTH) Value Between 150 to 300 pg/mL During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. | Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
|
|
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| Secondary | Number of Participants Who Achieve at Least 30% Reduction From Baseline in Intact Parathyroid Hormone (iPTH) as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 30% reduction from Baseline were counted. | Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value at least 2 iPTH values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
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| Secondary | Number of Participants Who Achieve at Least 50% Reduction From Baseline in iPTH as Assessed by the Mean iPTH Obtained During the Evaluation Period (Weeks 21 to 28). | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with both a baseline iPTH value and at least 2 iPTH values. Participants whose average iPTH value showed a 50% reduction from Baseline were counted. | Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
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| Secondary | Analysis of the Number of Participants Who Achieve a Mean iPTH Value Between 150 and 300 pg/mL During the Evaluation Period (Weeks 21 to 28) Using a Cochran-Mantel-Haenszel Test Controlling for IV and Oral Site Randomization Strata | iPTH values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 iPTH values. Participants whose average iPTH value was between 150 to 300 pg/mL were counted. Data from both the IV and oral strata were analyzed together. | Randomized participants who received at least 1 dose of study drug and who had both a baseline iPTH value and at least 2 iPTH values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
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| Secondary | Number of Participants With Hypocalcemia Defined as < 8.4 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) | Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was < 8.4 mg/dL were counted. | Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
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| Secondary | Number of Participants With Hypercalcemia Defined as Calcium > 10.5 mg/dL and Based on the Mean of at Least 2 Values Obtained During the Evaluation Period (Weeks 21 to 28) | Calcium values obtained during the evaluation period (Weeks 21 to 28) were averaged for each participant with at least 2 calcium values. Participants whose average calcium value was > 10.5 mg/dL were counted. | Randomized participants who received at least 1 dose of study drug and who had at least 2 calcium values during the evaluation period (Weeks 21 to 28) | Posted | Number | Participants | Weeks 21 to 28 |
|
Treatment-emergent adverse events were reported. These include all adverse events that began on or after the 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 | IV Paricalcitol in the IV Stratum | IV stratum | 22 | 62 | 48 | 62 | ||
| EG001 | Cinacalcet in the IV Stratum | IV stratum | 28 | 64 | 46 | 64 | ||
| EG002 | Oral Paricalcitol in the Oral Stratum | Oral stratum | 22 | 72 | 59 | 72 | ||
| EG003 | Cinacalcet in the Oral Stratum | Oral stratum | 15 | 70 | 54 | 70 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemolysis | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Acute myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Angina pectoris | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atril fibrillation | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac arrest | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cardiac failure congestive | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Coronary artery disease | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pericarditis | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Eye pain | Eye disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastric ulcer | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rectal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Malaise | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Medical device complication | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bacteraemia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Endocarditis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gangrene | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Purulent discharge | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Tubo-ovarian abscess | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula occlusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Perirenal haematoma | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Ulna fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular graft occlusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Failure to thrive | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fluid retention | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypervolaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.0 | Non-systematic Assessment |
| |
| Carotid artery stenosis | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebral infarction | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Convulsion | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Mental status changes | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Suicide attempt | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal cyst | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Renal failure chronic | Renal and urinary disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Lung infiltration | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Accelerated hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aortic aneurysm | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aortic dilatation | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Aortic stenosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Brachiocephalic vein stenosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhage | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Peripheral ischaemia | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular stenosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Venous stenosis | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Compression fracture | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dental caries | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diarhhoea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Diverticulum | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemorrhoidal haemorrhage | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula site infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula site complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arteriovenous fistula thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Procedural hypotension | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular graft complication | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Vascular graft thrombosis | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Wound | Injury, poisoning and procedural complications | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood calcium increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood parathyroid hormone increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood phosphorus increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Blood potassium increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| C-reactive protein increased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Haemoglobin decreased | Investigations | MedDRA 14.0 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hyperphosphataemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypoaesthesia | Nervous system disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rales | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
| |
| Steal syndrome | Vascular disorders | MedDRA 14.0 | Non-systematic Assessment |
|
Using a fixed dosing algorithm based on biochemical criteria may affect interpretation of the results. In the future, the risk/benefit profile of these interventions should be assessed by longer-term clinical outcomes.
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 |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006962 | Hyperparathyroidism, Secondary |
| ID | Term |
|---|---|
| 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 |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C084656 | paricalcitol |
| D000069449 | Cinacalcet |
| C042533 | 1 alpha-hydroxyergocalciferol |
| ID | Term |
|---|---|
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
Not provided
Not provided
| Male |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| No |
|
| With a sample size of 49 participants in each treatment group in the oral stratum, a Fisher's exact test with a 0.050 2-sided significance level will have 81% power to detect a 30% difference in the percentage of participants who achieve iPTH between 150 and 300 pg/mL, assuming the cinacalcet percentage is 36% and the paricalcitol percentage is 66%. | Fisher Exact | 0.260 | No adjustments were made for multiple comparisons between treatment groups since the study was designed to evaluate the primary outcome measure by testing a single hypothesis within each stratum independently. | 2-Sided | 95 | No | Superiority or Other |
|
|
|
|
|
|
Oral stratum
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|