Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Parathyroid Hormone Levels in Children Aged 10-16 With Chronic Kidney Disease (CKD)
Sponsor
AbbVie (prior sponsor, Abbott) (Industry)
Overall Status
Completed
CT.gov ID
NCT01020487
Collaborator
(none)
47
3
58
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
47 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase 3, Prospective, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Paricalcitol Capsules in Decreasing Serum Intact Parathyroid Hormone Levels in Pediatric Subjects Ages 10 to 16 Years With Moderate to Severe Chronic Kidney Disease
Study Start Date
:
Feb 1, 2010
Actual Primary Completion Date
:
May 1, 2014
Actual Study Completion Date
:
Dec 1, 2014
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Part 1: Paricalcitol Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
Drug: Paricalcitol
Paricalcitol capsules taken with water.
Other Names:
|
| Placebo Comparator: 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. |
Drug: Paricalcitol
Paricalcitol capsules taken with water.
Other Names:
Drug: Placebo
Placebo capsules taken with water
|
| Experimental: 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. |
Drug: Paricalcitol
Paricalcitol capsules taken with water.
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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 [12-week double-blind treatment period]
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.
Secondary Outcome Measures
- Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges [Week 12]
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.
- 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 [Week 12]
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).
- Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges [Week 12]
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).
- Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) [Baseline and Weeks 4, 8 and 12]
The mean change from Baseline in FMV UACR on a log scale to each post baseline visit.
Eligibility Criteria
Criteria
Ages Eligible for Study:
10 Years
to 16 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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:
-
estimated glomerular filtration rate between 15 to 59 mL/min/1.73 m².
-
iPTH measurement that is greater than or equal to 60 pg/mL (Stage 3 subjects) or greater than or equal to 90 pg/mL (Stage 4 subjects).
-
An adjusted serum calcium value greater than or equal to 8.2 mg/dL (2.05 mmol/L) to less than or equal to 10.5 mg/dL (2.63 mmol/L).
-
A serum phosphorus value greater than or equal to 2.0 mg/dL (0.65 mmol/L but less than or equal to 6.0 mg/dL (1.94 mmol/L).
-
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:
-
iPTH measurement that is greater than or equal to 75 pg/mL (Stage 3 subjects) or greater than or equal to 110 pg/mL (Stage 4 subjects).
-
An adjusted serum calcium value greater than or equal to 8.4 mg/dL (2.10 mmol/L) but less than or equal to 10.2 mg/dL (2.55 mmol/L).
-
A serum phosphorus value greater than or equal to 2.5 mg/dL (0.81 mmol/L) but less than or equal to 5.8 mg/dL (1.87 mmol/L).
-
Must have 25-hydroxyvitamin D levels ≥ 30 ng/mL prior to washout, if not VDRA naïve, or treatment in Part II of the study.
Exclusion Criteria:
-
All subjects that have had a small bowel transplant will be excluded from the study.
-
Subject has had acute kidney failure within 12 weeks of the Screening Phase (defined as an acute rise in serum creatinine).
-
Subject has had symptomatic or significant hypocalcemia requiring active vitamin D therapy (for example, calcitriol, paricalcitol, doxercalciferol or alfacalcidol) within 6 months prior to the Screening Phase.
-
Subject has a history of active kidney stones (6 months prior to screening).
-
Subject has chronic gastrointestinal disease, which in the investigator's opinion may cause significant gastrointestinal malabsorption.
-
Subject is taking maintenance calcitonin, bisphosphonates, cinacalcet, glucocorticoids in an equivalent dose of greater than 5 mg prednisone daily, or other drugs known to affect calcium or bone metabolism within 4 weeks prior to treatment.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- AbbVie (prior sponsor, Abbott)
Investigators
- Study Director: Deepa Chand, MD, AbbVie
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01020487
Other Study ID Numbers:
- M10-149
- 2010-019439-37
First Posted:
Nov 24, 2009
Last Update Posted:
Jul 2, 2018
Last Verified:
Feb 1, 2017
Keywords provided by AbbVie (prior sponsor, Abbott)
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | 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. |
|---|---|
| Pre-assignment Detail | 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. |
| Arm/Group Title | Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|---|
| Arm/Group Description | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. | 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. | 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. |
| Period Title: Part 1 | |||
| STARTED | 12 | 0 | 0 |
| COMPLETED | 12 | 0 | 0 |
| NOT COMPLETED | 0 | 0 | 0 |
| Period Title: Part 1 | |||
| STARTED | 0 | 18 | 19 |
| Received Treatment | 0 | 18 | 18 |
| COMPLETED | 0 | 16 | 13 |
| NOT COMPLETED | 0 | 2 | 6 |
| Period Title: Part 1 | |||
| STARTED | 0 | 16 | 13 |
| COMPLETED | 0 | 12 | 12 |
| NOT COMPLETED | 0 | 4 | 1 |
Baseline Characteristics
| Arm/Group Title | Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol | Total |
|---|---|---|---|---|
| Arm/Group Description | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. | 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. | 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. | Total of all reporting groups |
| Overall Participants | 12 | 18 | 19 | 49 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Part 1 |
13.5
(1.98)
|
13.5
(1.98)
|
||
| Part 2 |
13.3
(1.75)
|
13.9
(1.81)
|
13.6
(1.78)
|
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
3
25%
|
5
27.8%
|
6
31.6%
|
14
28.6%
|
| Male |
9
75%
|
13
72.2%
|
13
68.4%
|
35
71.4%
|
| Race/Ethnicity, Customized (Count of Participants) | ||||
| White |
10
83.3%
|
17
94.4%
|
14
73.7%
|
41
83.7%
|
| Black |
1
8.3%
|
0
0%
|
0
0%
|
1
2%
|
| Asian |
0
0%
|
0
0%
|
4
21.1%
|
4
8.2%
|
| American Indian/Alaska Native |
1
8.3%
|
0
0%
|
0
0%
|
1
2%
|
| Native Hawaiian or other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Other |
0
0%
|
1
5.6%
|
1
5.3%
|
2
4.1%
|
| Chronic Kidney Disease Stage (Count of Participants) | ||||
| Stage 3 |
6
50%
|
11
61.1%
|
10
52.6%
|
27
55.1%
|
| Stage 4 |
6
50%
|
7
38.9%
|
8
42.1%
|
21
42.9%
|
| Missing |
0
0%
|
0
0%
|
1
5.3%
|
1
2%
|
Outcome Measures
| Title | Part 1: Paricalcitol Maximum Observed Plasma Concentration (Cmax) |
|---|---|
| Description | |
| Time Frame | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled and administered paricalcitol for the pharmacokinetic (PK) period, Part 1 |
| Arm/Group Title | Part 1: Paricalcitol |
|---|---|
| Arm/Group Description | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| Measure Participants | 12 |
| Mean (Standard Deviation) [ng/mL] |
0.13
(0.052)
|
| Title | Part 1: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC0-∞) |
|---|---|
| Description | |
| Time Frame | Blood samples were collected at hour 0, 1, 2, 4, 6, 8, 12, 24, 36, and 48 hours after dosing. |
Outcome Measure Data
| Analysis Population Description |
|---|
| All participants enrolled and administered paricalcitol for the PK Portion, Part 1 |
| Arm/Group Title | Part 1: Paricalcitol |
|---|---|
| Arm/Group Description | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. |
| Measure Participants | 12 |
| Mean (Standard Deviation) [ng*hr/mL] |
2.87
(0.84)
|
| Title | Part 2: Percentage of Participants Achieving Two Consecutive Reductions at Least 30% From Baseline in iPTH |
|---|---|
| Description | 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. |
| Time Frame | 12-week double-blind treatment period |
Outcome Measure Data
| Analysis Population Description |
|---|
| The Intent-To-Treat (ITT) Dataset, defined as the set of all randomized participants who took at least one dose of study drug. |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Number [percentage of participants] |
0
0%
|
27.8
154.4%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Treatment effects were evaluated based on a two-sided significance level of 0.050. The primary efficacy analysis was a comparison between the paricalcitol capsules and placebo groups in the percentage of participants achieving 2 consecutive ≥ 30% reductions in iPTH from baseline regardless of CKD stage conducted using Fisher's exact test. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.045 |
| Comments | ||
| Method | Fisher Exact | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 27.8 | |
| Confidence Interval |
(2-Sided) 95% 7.5 to 52.8 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Part 2: Percentage of Participants Achieving a Final iPTH Within KDOQI Target Ranges |
|---|---|
| Description | 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. |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat dataset |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Number [percentage of participants] |
11.1
92.5%
|
33.3
185%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.128 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage. | |
| Title | Part 2: Change From Baseline in iPTH to Each Post-baseline Visit |
|---|---|
| Description | |
| Time Frame | Baseline and Weeks 2, 4, 8 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat dataset with available data at each time point |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Week 2 |
50.39
(15.186)
|
-12.16
(14.695)
|
| Week 4 |
57.16
(20.813)
|
-11.27
(22.117)
|
| Week 8 |
57.31
(22.099)
|
-12.79
(24.814)
|
| Week 12 |
71.47
(17.661)
|
-17.05
(19.186)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Overall Comparison (all time points): A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | < 0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Differenbce |
| Estimated Value | -72.40 | |
| Confidence Interval |
(2-Sided) 95% -108.05 to -36.75 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 2 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.006 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -62.55 | |
| Confidence Interval |
(2-Sided) 95% -105.60 to -19.49 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.032 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -68.43 | |
| Confidence Interval |
(2-Sided) 95% -130.39 to -6.47 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 8 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.043 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -70.09 | |
| Confidence Interval |
(2-Sided) 95% -137.82 to -2.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 5
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 12 Comparison: A mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.002 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -88.52 | |
| Confidence Interval |
(2-Sided) 95% -142.04 to -35.01 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Part 2: Percentage of Participants Achieving Final Calcium Levels Within KDOQI Target Ranges |
|---|---|
| Description | 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). |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat dataset |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Number [percentage of participants] |
94.4
786.7%
|
83.3
462.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.327 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage. | |
| Title | Part 2: Percentage of Participants Achieving Final Phosphorus Levels Within KDOQI Target Ranges |
|---|---|
| Description | 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). |
| Time Frame | Week 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat dataset |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 18 | 18 |
| Number [percentage of participants] |
72.2
601.7%
|
50.0
277.8%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.194 |
| Comments | ||
| Method | Cochran-Mantel-Haenszel | |
| Comments | Cochran-Mantel-Haenszel (CHM) test, adjusting for CKD Stage. | |
| Title | Part 2: Change From Baseline in First Morning Void (FMV) Urinary Albumin to Creatinine Ratio (UACR) |
|---|---|
| Description | The mean change from Baseline in FMV UACR on a log scale to each post baseline visit. |
| Time Frame | Baseline and Weeks 4, 8 and 12 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent-to-treat dataset with available Baseline data, and available data at each time point |
| Arm/Group Title | Part 2: Placebo | Part 2: Paricalcitol |
|---|---|---|
| Arm/Group Description | 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. | 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. |
| Measure Participants | 15 | 16 |
| Week 4 |
-0.12
(0.126)
|
-0.13
(0.132)
|
| Week 8 |
-0.13
(0.141)
|
-0.01
(0.155)
|
| Week 12 |
-0.08
(0.259)
|
0.22
(0.292)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Overall Comparison (all time points): a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.469 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.14 | |
| Confidence Interval |
(2-Sided) 95% -0.25 to 0.53 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 4 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement. | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.975 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | -0.01 | |
| Confidence Interval |
(2-Sided) 95% -0.39 to 0.37 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 3
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 8 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.567 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.12 | |
| Confidence Interval |
(2-Sided) 95% -0.32 to 0.56 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Statistical Analysis 4
| Statistical Analysis Overview | Comparison Group Selection | Part 1: Paricalcitol, Part 2: Paricalcitol |
|---|---|---|
| Comments | Week 12 Comparison: a mixed effects repeated measures analysis using all the longitudinal observations across the visits including the fixed categorical effects of treatment, visit, and treatment-by-visit interaction, and the continuous covariate of baseline measurement | |
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.462 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Difference |
| Estimated Value | 0.30 | |
| Confidence Interval |
(2-Sided) 95% -0.53 to 1.12 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | 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). | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||
| Arm/Group Title | Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol | Part 2: Placebo/Paricalcitol | Part 2: Paricalcitol/Paricalcitol | |||||
| Arm/Group Description | Participants received a single 3 µg dose of paricalcitol capsules on Study Day 1. | Participants received placebo capsules three times a week for 12 weeks during the double-blind treatment phase. | 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. | 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. | 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). | |||||
All Cause Mortality |
||||||||||
| Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol | Part 2: Placebo/Paricalcitol | Part 2: Paricalcitol/Paricalcitol | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | |||||
Serious Adverse Events |
||||||||||
| Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol | Part 2: Placebo/Paricalcitol | Part 2: Paricalcitol/Paricalcitol | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/12 (0%) | 2/18 (11.1%) | 0/18 (0%) | 1/16 (6.3%) | 1/13 (7.7%) | |||||
| Gastrointestinal disorders | ||||||||||
| ABDOMINAL PAIN | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Infections and infestations | ||||||||||
| VIRAL INFECTION | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Investigations | ||||||||||
| BLOOD CREATININE INCREASED | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Psychiatric disorders | ||||||||||
| HOMICIDAL IDEATION | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| SUICIDAL IDEATION | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| RENAL FAILURE CHRONIC | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| RENAL IMPAIRMENT | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Vascular disorders | ||||||||||
| HYPERTENSIVE CRISIS | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
Other (Not Including Serious) Adverse Events |
||||||||||
| Part 1: Paricalcitol | Part 2: Placebo | Part 2: Paricalcitol | Part 2: Placebo/Paricalcitol | Part 2: Paricalcitol/Paricalcitol | ||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/12 (16.7%) | 15/18 (83.3%) | 7/18 (38.9%) | 12/16 (75%) | 5/13 (38.5%) | |||||
| Blood and lymphatic system disorders | ||||||||||
| ANAEMIA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| IRON DEFICIENCY ANAEMIA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| LYMPHADENOPATHY | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Ear and labyrinth disorders | ||||||||||
| EAR PAIN | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 2/16 (12.5%) | 0/13 (0%) | |||||
| Endocrine disorders | ||||||||||
| HYPERPARATHYROIDISM | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Gastrointestinal disorders | ||||||||||
| ABDOMINAL PAIN | 1/12 (8.3%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| CONSTIPATION | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| DIARRHOEA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| GASTRITIS | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| NAUSEA | 1/12 (8.3%) | 0/18 (0%) | 1/18 (5.6%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| TOOTHACHE | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| VOMITING | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| General disorders | ||||||||||
| FEELING HOT | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| OEDEMA PERIPHERAL | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| PYREXIA | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Infections and infestations | ||||||||||
| ACUTE SINUSITIS | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| CONJUNCTIVITIS | 0/12 (0%) | 0/18 (0%) | 1/18 (5.6%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| GASTROENTERITIS | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| HERPES SIMPLEX | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| IMPETIGO | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| INFLUENZA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| NASOPHARYNGITIS | 0/12 (0%) | 2/18 (11.1%) | 0/18 (0%) | 1/16 (6.3%) | 2/13 (15.4%) | |||||
| OTITIS MEDIA | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| PARONYCHIA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| PHARYNGITIS STREPTOCOCCAL | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 2/16 (12.5%) | 0/13 (0%) | |||||
| RHINITIS | 0/12 (0%) | 0/18 (0%) | 3/18 (16.7%) | 0/16 (0%) | 0/13 (0%) | |||||
| TOOTH INFECTION | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| UPPER RESPIRATORY TRACT INFECTION | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 2/16 (12.5%) | 0/13 (0%) | |||||
| VIRAL INFECTION | 0/12 (0%) | 2/18 (11.1%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Injury, poisoning and procedural complications | ||||||||||
| INJURY | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Investigations | ||||||||||
| BLOOD POTASSIUM INCREASED | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| VITAMIN D DECREASED | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Metabolism and nutrition disorders | ||||||||||
| ACIDOSIS | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| HYPERCALCAEMIA | 0/12 (0%) | 2/18 (11.1%) | 1/18 (5.6%) | 3/16 (18.8%) | 0/13 (0%) | |||||
| HYPERKALAEMIA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 3/16 (18.8%) | 0/13 (0%) | |||||
| HYPERPHOSPHATAEMIA | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 2/16 (12.5%) | 0/13 (0%) | |||||
| METABOLIC ACIDOSIS | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Musculoskeletal and connective tissue disorders | ||||||||||
| ARTHRALGIA | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| MUSCLE SPASMS | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| Nervous system disorders | ||||||||||
| DIZZINESS | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| HEADACHE | 1/12 (8.3%) | 1/18 (5.6%) | 0/18 (0%) | 1/16 (6.3%) | 1/13 (7.7%) | |||||
| SYNCOPE | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Psychiatric disorders | ||||||||||
| THINKING ABNORMAL | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 0/16 (0%) | 0/13 (0%) | |||||
| Renal and urinary disorders | ||||||||||
| MICTURITION URGENCY | 0/12 (0%) | 0/18 (0%) | 1/18 (5.6%) | 0/16 (0%) | 0/13 (0%) | |||||
| PROTEINURIA | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| RENAL FAILURE CHRONIC | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||
| ASTHMA | 0/12 (0%) | 0/18 (0%) | 1/18 (5.6%) | 0/16 (0%) | 0/13 (0%) | |||||
| COUGH | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 1/16 (6.3%) | 1/13 (7.7%) | |||||
| EPISTAXIS | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 1/13 (7.7%) | |||||
| NASAL CONGESTION | 0/12 (0%) | 1/18 (5.6%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| OROPHARYNGEAL PAIN | 0/12 (0%) | 1/18 (5.6%) | 1/18 (5.6%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| RHINORRHOEA | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| WHEEZING | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| Skin and subcutaneous tissue disorders | ||||||||||
| ACNE | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| COLD SWEAT | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 0/16 (0%) | 1/13 (7.7%) | |||||
| INGROWING NAIL | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| RASH | 0/12 (0%) | 0/18 (0%) | 0/18 (0%) | 1/16 (6.3%) | 0/13 (0%) | |||||
| Vascular disorders | ||||||||||
| HYPERTENSION | 0/12 (0%) | 1/18 (5.6%) | 1/18 (5.6%) | 0/16 (0%) | 0/13 (0%) | |||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Global Medical Services |
|---|---|
| Organization | AbbVie (prior sponsor, Abbott) |
| Phone | 800-633-9110 |
Responsible Party:
AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier:
NCT01020487
Other Study ID Numbers:
- M10-149
- 2010-019439-37
First Posted:
Nov 24, 2009
Last Update Posted:
Jul 2, 2018
Last Verified:
Feb 1, 2017