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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-019439-37 | EudraCT Number |
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Part 1: To determine the safety, tolerability, and pharmacokinetics of a single dose of 3 μg paricalcitol capsules in children ages 10 to 16 years with moderate to severe chronic kidney disease (CKD Stages 3 and 4).
Part 2: To determine the safety and efficacy of paricalcitol capsules as compared to placebo in decreasing serum intact parathyroid hormone (iPTH) in children ages 10 to 16 years with moderate to severe chronic kidney disease with an initial 12 weeks of double-blinded study drug followed by a minimum of 12 weeks of open-label active drug.
The study consists of two parts. Part 1 is an open-label single-dose, non-fasting, multicenter study to evaluate the pharmacokinetics (PK) of paricalcitol capsules in 12 children ages 10 to 16 years with CKD Stages 3 and 4. Part 2 of this study will be conducted as a 12 week randomized double-blind, placebo-controlled study, followed by 12 weeks open-label treatment. Participants active or enrolled under amendment 5 will enter a follow-up period and have study visits every 4 weeks until the final participant reaches Week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1: Paricalcitol | Experimental | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
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| Part 2: Placebo | Placebo Comparator | Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. |
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| Part 2: Paricalcitol | Experimental | Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paricalcitol | Drug | Paricalcitol capsules taken with water. |
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| Measure | Description | Time Frame |
|---|---|---|
| Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax) | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. | |
| Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. | |
| Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH | The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage. | 12-week double-blind treatment period |
| Measure | Description | Time Frame |
|---|---|---|
| Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges | The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows:: CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL. | Week 12 |
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Inclusion Criteria:
Subject has chronic kidney disease Stage 3 or 4 as determined by estimated glomerular filtration rate (15 to 59 mL/min/1.73 m²) at Screening.
Subject is not expected to begin dialysis for at least 6 months (in the opinion of the investigator).
For entry into the Washout Period (for subjects who are currently on a vitamin D receptor activator [VDRA] and need to complete a 2 to 4 week washout), the subject must satisfy the following criteria based on the Screening laboratory values:
For entry into the Treatment Phase (vitamin D receptor activator naïve subjects and those that have completed a 4 week washout), the subject must have:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Deepa Chand, MD | AbbVie | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28332096 | Result | Webb NJA, Lerner G, Warady BA, Dell KM, Greenbaum LA, Ariceta G, Hoppe B, Linde P, Lee HJ, Eldred A, Dufek MB. Efficacy and safety of paricalcitol in children with stages 3 to 5 chronic kidney disease. Pediatr Nephrol. 2017 Jul;32(7):1221-1232. doi: 10.1007/s00467-017-3579-6. Epub 2017 Mar 22. |
| Label | URL |
|---|---|
| Related Info | View source |
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Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants is equal to 47.
Part 1 was an open-label, single-dose study evaluating the pharmacokinetics of paricalcitol capsules in children with moderate to severe chronic kidney disease (CKD). Part 2 consisted of a double-blind, placebo-controlled study to evaluate safety and efficacy of paricalcitol and an open-label phase where all participants received paricalcitol.
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| ID | Title | Description |
|---|---|---|
| FG000 | Part 1: Paricalcitol | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| FG001 | Part 2: Placebo | Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Part 1 |
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| Placebo | Drug | Placebo capsules taken with water |
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| Part 2: Change From Baseline in iPTH to Each Post-baseline Visit | Baseline and Weeks 2, 4, 8 and 12 |
| Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges | KDOQI recommends serum calcium is maintained within age appropriate normal ranges: Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L). | Week 12 |
| Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges | The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits: Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L). | Week 12 |
| Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) | The mean change from Baseline in FMV UACR on a log scale to each post baseline visit. | Baseline and Weeks 4, 8 and 12 |
| FG002 | Part 2: Paricalcitol | Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. |
| COMPLETED |
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| NOT COMPLETED |
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| Part 2 Double-blind Treatment Period |
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| Part 2 Open-label Period |
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All enrolled participants. Note: Two participants enrolled in Part 2 after completing Part 1 of the study, hence the actual total number of enrolled participants was 47. These 2 participants are counted in both arms they enrolled in for Baseline Measure data and are hence double-counted in the Total column for gender, race and CKD stage.
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| ID | Title | Description |
|---|---|---|
| BG000 | Part 1: Paricalcitol | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| BG001 | Part 2: Placebo | Participants received placebo capsules three times a week (TIW) for 12 weeks during the double-blind treatment phase. From Weeks 12 to 24 participants received open-label paricalcitol at an initial dose of 1 µg three times a week. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) target levels. |
| BG002 | Part 2: Paricalcitol | Participants received paricalcitol three times a week for 12 weeks during the double-blind treatment period and during the open-label period (Weeks 12-24). The initial dose of paricalcitol was 1 µg TIW. Doses could be increased in 1 μg increments every 4 weeks based on chemistry evaluations to target KDOQI target levels. |
| BG003 | 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 | Baseline measure data were analyzed separately for participants in Part 1 and Part 2. | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Chronic Kidney Disease Stage | Stage 3: estimated glomerular filtration rate (eGFR) 30 to 59 mL/min/1.73 m²; Stage 4: eGFR 15 to 29 mL/min/1.73 m², not requiring dialysis | Count of Participants | 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 | Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax) | All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1 | Posted | Mean | Standard Deviation | ng/mL | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. |
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| Primary | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) | All participants enrolled and administered paricalcitol for the PK Portion, Part 1 | Posted | Mean | Standard Deviation | ng*hr/mL | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. |
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| Primary | Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH | The primary efficacy endpoint was the percentage of participants who achieved two consecutive ≥ 30% reductions from baseline in intact parathyroid hormone (iPTH) levels during the 12 week double-blind portion of the study regardless of CKD stage. | The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug. | Posted | Number | percentage of participants | 12-week double-blind treatment period |
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| Secondary | Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges | The Kidney Disease Outcomes Quality Initiatives (KDOQI) Pediatric Subcommittee on Practice Guidelines for Bone Metabolism and Disease in Children with CKD target range for intact parathyroid hormone (iPTH) is as follows:: CKD Stage 3: 35 - 69 pg/mL; CKD Stage 4: 70 - 110 pg/mL. | Intent to treat dataset | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Part 2: Change From Baseline in iPTH to Each Post-baseline Visit | Intent to treat dataset with available data at each time point | Posted | Least Squares Mean | Standard Error | pg/mL | Baseline and Weeks 2, 4, 8 and 12 |
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| Secondary | Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges | KDOQI recommends serum calcium is maintained within age appropriate normal ranges: Age 6 - 12: 9.4 - 10.2 mg/dL (2.35 - 2.55 mmol/L); Age 13 - 20: 8.8 - 10.2 mg/dL (2.20 - 2.55 mmol/L). | Intent to treat dataset | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges | The KDOQI target ranges of serum phosphorus are to maintain at or above age appropriate lower limits and no higher than the age-appropriate upper limits: Age 6 - 12: 3.6 - 5.8 mg/dL (1.16 - 1.87 mmol/L); Age 13 - 20: 2.3 - 4.5 mg/dL (0.74 - 1.45 mmol/L). | Intent to treat dataset | Posted | Number | percentage of participants | Week 12 |
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| Secondary | Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) | The mean change from Baseline in FMV UACR on a log scale to each post baseline visit. | Intent-to-treat dataset with available Baseline data, and available data at each time point | Posted | Least Squares Mean | Standard Error | mg/g | Baseline and Weeks 4, 8 and 12 |
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Part 1: From the time of study drug administration through 30 days following the single dose of study drug. Part 2 Double-blind Period: From the first dose of study drug until the last dose of study drug during the double-blind period (12 weeks). Part 2 Open-label Period: From the first dose during the open-label period until 30 days after the last dose of study drug during the open-label period (up to 16 weeks).
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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 | Part 1: Paricalcitol | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. | 0 | 12 | 2 | 12 | ||
| EG001 | Part 2: Placebo | Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase. | 2 | 18 | 15 | 18 | ||
| EG002 | Part 2: Paricalcitol | Participants received paricalcitol three times a week (TIW) for 12 weeks during the double-blind treatment period. The initial dose of paricalcitol was 1 µg TIW. Doses could be adjusted based on chemistry evaluations to target Kidney Disease Outcomes Quality Initiatives (KDOQI) levels. | 0 | 18 | 7 | 18 | ||
| EG003 | Part 2: Placebo/Paricalcitol | Participants who received placebo in the double-blind treatment phase received open-label paricalcitol at an initial dose of 1 µg three times a week in the open- label treatment phase (Weeks 12-24). Doses could be adjusted based on chemistry evaluations to target KDOQI levels. | 1 | 16 | 12 | 16 | ||
| EG004 | Part 2: Paricalcitol/Paricalcitol | Participants who received paricalcitol during the double-blind treatment period continued to receive paricalcitol three times a week during the open-label period (Weeks 12-24). | 1 | 13 | 5 | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| BLOOD CREATININE INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| HOMICIDAL IDEATION | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| SUICIDAL IDEATION | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| RENAL IMPAIRMENT | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERTENSIVE CRISIS | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| IRON DEFICIENCY ANAEMIA | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| LYMPHADENOPATHY | Blood and lymphatic system disorders | MedDRA 17.1 | Systematic Assessment |
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| EAR PAIN | Ear and labyrinth disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERPARATHYROIDISM | Endocrine disorders | MedDRA 17.1 | Systematic Assessment |
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| ABDOMINAL PAIN | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| CONSTIPATION | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| DIARRHOEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| GASTRITIS | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| TOOTHACHE | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| VOMITING | Gastrointestinal disorders | MedDRA 17.1 | Systematic Assessment |
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| FEELING HOT | General disorders | MedDRA 17.1 | Systematic Assessment |
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| OEDEMA PERIPHERAL | General disorders | MedDRA 17.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 17.1 | Systematic Assessment |
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| ACUTE SINUSITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| CONJUNCTIVITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| GASTROENTERITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| HERPES SIMPLEX | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| IMPETIGO | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| NASOPHARYNGITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| OTITIS MEDIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| PARONYCHIA | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| PHARYNGITIS STREPTOCOCCAL | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| RHINITIS | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| TOOTH INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| VIRAL INFECTION | Infections and infestations | MedDRA 17.1 | Systematic Assessment |
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| INJURY | Injury, poisoning and procedural complications | MedDRA 17.1 | Systematic Assessment |
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| BLOOD POTASSIUM INCREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| VITAMIN D DECREASED | Investigations | MedDRA 17.1 | Systematic Assessment |
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| ACIDOSIS | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERCALCAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERKALAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERPHOSPHATAEMIA | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| METABOLIC ACIDOSIS | Metabolism and nutrition disorders | MedDRA 17.1 | Systematic Assessment |
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| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| DIZZINESS | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| SYNCOPE | Nervous system disorders | MedDRA 17.1 | Systematic Assessment |
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| THINKING ABNORMAL | Psychiatric disorders | MedDRA 17.1 | Systematic Assessment |
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| MICTURITION URGENCY | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| PROTEINURIA | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| RENAL FAILURE CHRONIC | Renal and urinary disorders | MedDRA 17.1 | Systematic Assessment |
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| ASTHMA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| EPISTAXIS | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| NASAL CONGESTION | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| RHINORRHOEA | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| WHEEZING | Respiratory, thoracic and mediastinal disorders | MedDRA 17.1 | Systematic Assessment |
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| ACNE | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| COLD SWEAT | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| INGROWING NAIL | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| RASH | Skin and subcutaneous tissue disorders | MedDRA 17.1 | Systematic Assessment |
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| HYPERTENSION | Vascular disorders | MedDRA 17.1 | Systematic Assessment |
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AbbVie 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. AbbVie 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 AbbVie needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie (prior sponsor, Abbott) | 800-633-9110 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| 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 |
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| ID | Term |
|---|---|
| C084656 | paricalcitol |
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| Required a Dose Reduction |
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| Randomized in Error |
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| Part 2 |
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