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The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4 (PRIMO)

Primary Purpose

Chronic Kidney Disease, Left Ventricular Hypertrophy

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
paricalcitol
placebo
Sponsored by
AbbVie (prior sponsor, Abbott)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring paricalcitol, Zemplar, PRIMO, Chronic Kidney Disease Stage 3B/4

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Estimated glomerular filtration rate (GFR) between 15-60 mL/min/1.73 m^2
  • Serum intact parathyroid hormone (iPTH) value between 50-300 pg/mL
  • Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L)
  • Phosphorous level less than or equal to 5.2 mg/dL (1.68 mmol/L)
  • Serum albumin greater than or equal to 3.0 g/dL (30 g/L)

  • Echocardiogram results of:

    • Females: Left ventricular (LV) ejection fraction greater than or equal to 50% and septal wall thickness between 11-17 mm; and,
    • Males: LV ejection fraction greater than or equal to 50% and septal wall thickness between 12-18 mm
  • If the subject is receiving renin-angiotensin-aldosterone system (RAAS) inhibitors the dose must have been stable for greater than one month prior to the Screening Period. However, the subject may have switched to different brands but at equivalent doses as determined by the study physician during the month prior to the Screening Period.
  • Subject must have a technically adequate baseline cardiac magnetic resonance imaging (MRI).

Exclusion Criteria:

  • Subject has previously been on active vitamin D therapy within the four weeks prior to the Screening Period
  • Pregnant or lactating females
  • Subject is expected to initiate renal replacement therapy within one year
  • Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids)
  • Subject had clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as either hospitalization for myocardial infarction (MI) or unstable angina; new onset angina with positive functional study or coronary angiogram revealing stenosis; or coronary revascularization procedure.
  • Subject had major cardiac valve abnormality linked with LVH and/or diastolic dysfunction, defined as either aortic valve area ≤ 1.5 cm^2 or a mean gradient of > 20 mmHg; or regurgitation lesions; more than moderate mitral regurgitation, or more than moderate aortic regurgitation.
  • Subject had asymmetric septal hypertrophy defined as septal wall thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram.
  • Subject had a severe cerebrovascular accident (CVA) within the last 3 months (e.g., hemorrhagic) prior to screening.
  • Subject had full remission from a malignancy for less than 1 year except completely excised non-melanoma skin cancer (e.g., basal or squamous carcinoma) or any history of bone metastasis.
  • Subject had comorbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.

Sites / Locations

  • Site Reference ID/Investigator# 8062
  • Site Reference ID/Investigator# 8867
  • Site Reference ID/Investigator# 8864
  • Site Reference ID/Investigator# 7257
  • Site Reference ID/Investigator# 7727
  • Site Reference ID/Investigator# 8861
  • Site Reference ID/Investigator# 7260
  • Site Reference ID/Investigator# 7725
  • Site Reference ID/Investigator# 7824
  • Site Reference ID/Investigator# 18882
  • Site Reference ID/Investigator# 7823
  • Site Reference ID/Investigator# 7249
  • Site Reference ID/Investigator# 7816
  • Site Reference ID/Investigator# 18881
  • Site Reference ID/Investigator# 7817
  • Site Reference ID/Investigator# 7245
  • Site Reference ID/Investigator# 7248
  • Site Reference ID/Investigator# 8868
  • Site Reference ID/Investigator# 7828
  • Site Reference ID/Investigator# 14442
  • Site Reference ID/Investigator# 6567
  • Site Reference ID/Investigator# 7262
  • Site Reference ID/Investigator# 7826
  • Site Reference ID/Investigator# 8865
  • Site Reference ID/Investigator# 7261
  • Site Reference ID/Investigator# 8058
  • Site Reference ID/Investigator# 7830
  • Site Reference ID/Investigator# 7825
  • Site Reference ID/Investigator# 8866
  • Site Reference ID/Investigator# 7263
  • Site Reference ID/Investigator# 8493
  • Site Reference ID/Investigator# 8506
  • Site Reference ID/Investigator# 8507
  • Site Reference ID/Investigator# 9581
  • Site Reference ID/Investigator# 9582
  • Site Reference ID/Investigator# 8500
  • Site Reference ID/Investigator# 8246
  • Site Reference ID/Investigator# 8499
  • Site Reference ID/Investigator# 8245
  • Site Reference ID/Investigator# 6692
  • Site Reference ID/Investigator# 9723
  • Site Reference ID/Investigator# 6630
  • Site Reference ID/Investigator# 7268
  • Site Reference ID/Investigator# 6622
  • Site Reference ID/Investigator# 10626
  • Site Reference ID/Investigator# 8070
  • Site Reference ID/Investigator# 8060
  • Site Reference ID/Investigator# 8519
  • Site Reference ID/Investigator# 7702
  • Site Reference ID/Investigator# 7269
  • Site Reference ID/Investigator# 7818
  • Site Reference ID/Investigator# 7270
  • Site Reference ID/Investigator# 7712
  • Site Reference ID/Investigator# 7266
  • Site Reference ID/Investigator# 8881
  • Site Reference ID/Investigator# 8518
  • Site Reference ID/Investigator# 8514
  • Site Reference ID/Investigator# 22682
  • Site Reference ID/Investigator# 8009
  • Site Reference ID/Investigator# 7251
  • Site Reference ID/Investigator# 7250
  • Site Reference ID/Investigator# 8883
  • Site Reference ID/Investigator# 8358
  • Site Reference ID/Investigator# 8355
  • Site Reference ID/Investigator# 8356
  • Site Reference ID/Investigator# 8882
  • Site Reference ID/Investigator# 8234
  • Site Reference ID/Investigator# 8884
  • Site Reference ID/Investigator# 8228
  • Site Reference ID/Investigator# 8229
  • Site Reference ID/Investigator# 8823

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Paricalcitol

Placebo

Arm Description

Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.

Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.

Outcomes

Primary Outcome Measures

Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.

Secondary Outcome Measures

Change in Diastolic Mitral Annular Relaxation Velocity (E')
Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')
The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.
Change in E-wave Deceleration Time (DT)
E-wave deceleration time (DT) is a measure of diastolic function.
Change in Isovolumetric Relaxation Time (IVRT)
Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Change in Left Atrial Volume
Left atrial volume is a measure of diastolic function.
Change in Plasma Triiodothyronine (T3)
Plasma triiodothyronine (T3) is a biological and inflammatory marker.
Change in Interleukin-6 (IL-6)
Interleukin-6 (IL-6) is a biological and inflammatory marker.
Change in Troponin-T
Troponin-T is a biological and inflammatory marker.
Change in B-type Natriuretic Peptide (BNP)
B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
Change in High Sensitivity C-reactive Protein (hsCRP)
High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
Change in Progression of Thoraco-abdominal Aortic Plaque Volume
Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.
Change in Progression of Thoraco-abdominal Aortic Wall Volume
Change from baseline to Week 48 in thoraco-abdominal aortic wall volume
Change in Progression of Aortic Compliance
Change from baseline to Week 48 in aortic compliance.
Change in Progression of Left Ventricular End-systolic Volume Index
Change from baseline to Week 48 in left ventricular end-systolic volume index.
Change in Progression of Left Ventricular End-diastolic Volume Index
Change from baseline to Week 48 in left ventricular end-diastolic volume index.
Change in Progression of Left Ventricular Ejection Fraction
Change from baseline to Week 48 in left ventricular ejection fraction.

Full Information

First Posted
July 3, 2007
Last Updated
March 8, 2013
Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00497146
Brief Title
The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Acronym
PRIMO
Official Title
The PRIMO Study: Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie (prior sponsor, Abbott)
Collaborators
Massachusetts General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48 weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular hypertrophy (LVH).
Detailed Description
Patients who met the inclusion criteria and did not meet any of the exclusion criteria were randomized in a 1:1 ratio to each treatment group to receive paricalcitol capsules or placebo. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, gender, and baseline renin angiotensin-aldosterone system (RAAS) inhibitor use (yes/no). Participants who completed the 48-Week Treatment Period could continue on in the ongoing Long-term Follow-up Period that was to last 18 months, with study visits at 6 months, 12 months and 18 months post Treatment Week 48 Visit. Participants did not receive study drug, nor were they to have undergone echocardiogram/MRI procedures during the Long-term Follow-up Period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Left Ventricular Hypertrophy
Keywords
paricalcitol, Zemplar, PRIMO, Chronic Kidney Disease Stage 3B/4

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
227 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol
Arm Type
Experimental
Arm Description
Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
Intervention Type
Drug
Intervention Name(s)
paricalcitol
Other Intervention Name(s)
ABT-358, Zemplar
Intervention Description
2 µg capsule
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo capsule
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Description
The Central Cardiac MRI Core Laboratory (CCL) interpreted and analyzed all cardiac MRI data. Left Ventricular Mass (LVM) was normalized to the participant's height by the following equation to obtain LVMI: LVM (grams) divided by height (meters)^2.7.
Time Frame
Baseline to 48 weeks
Secondary Outcome Measure Information:
Title
Change in Diastolic Mitral Annular Relaxation Velocity (E')
Description
Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Time Frame
Baseline to 48 weeks
Title
Change in Ratio of Peak E Wave Velocity to Lateral E Wave Velocity (E/E')
Description
The ratio of peak E wave velocity to lateral E wave velocity (E/E') is a measure of diastolic function.
Time Frame
Baseline to 48 weeks
Title
Change in E-wave Deceleration Time (DT)
Description
E-wave deceleration time (DT) is a measure of diastolic function.
Time Frame
Baseline to 48 weeks
Title
Change in Isovolumetric Relaxation Time (IVRT)
Description
Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Time Frame
Baseline to 48 weeks
Title
Change in Left Atrial Volume
Description
Left atrial volume is a measure of diastolic function.
Time Frame
Baseline to 48 weeks
Title
Change in Plasma Triiodothyronine (T3)
Description
Plasma triiodothyronine (T3) is a biological and inflammatory marker.
Time Frame
Baseline to 48 weeks
Title
Change in Interleukin-6 (IL-6)
Description
Interleukin-6 (IL-6) is a biological and inflammatory marker.
Time Frame
Baseline to 48 weeks
Title
Change in Troponin-T
Description
Troponin-T is a biological and inflammatory marker.
Time Frame
Baseline to 48 weeks
Title
Change in B-type Natriuretic Peptide (BNP)
Description
B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
Time Frame
Baseline to 48 weeks
Title
Change in High Sensitivity C-reactive Protein (hsCRP)
Description
High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Thoraco-abdominal Aortic Plaque Volume
Description
Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Thoraco-abdominal Aortic Wall Volume
Description
Change from baseline to Week 48 in thoraco-abdominal aortic wall volume
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Aortic Compliance
Description
Change from baseline to Week 48 in aortic compliance.
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Left Ventricular End-systolic Volume Index
Description
Change from baseline to Week 48 in left ventricular end-systolic volume index.
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Left Ventricular End-diastolic Volume Index
Description
Change from baseline to Week 48 in left ventricular end-diastolic volume index.
Time Frame
Baseline to 48 weeks
Title
Change in Progression of Left Ventricular Ejection Fraction
Description
Change from baseline to Week 48 in left ventricular ejection fraction.
Time Frame
Baseline to 48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Estimated glomerular filtration rate (GFR) between 15-60 mL/min/1.73 m^2 Serum intact parathyroid hormone (iPTH) value between 50-300 pg/mL Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L) Phosphorous level less than or equal to 5.2 mg/dL (1.68 mmol/L) Serum albumin greater than or equal to 3.0 g/dL (30 g/L) Echocardiogram results of: Females: Left ventricular (LV) ejection fraction greater than or equal to 50% and septal wall thickness between 11-17 mm; and, Males: LV ejection fraction greater than or equal to 50% and septal wall thickness between 12-18 mm If the subject is receiving renin-angiotensin-aldosterone system (RAAS) inhibitors the dose must have been stable for greater than one month prior to the Screening Period. However, the subject may have switched to different brands but at equivalent doses as determined by the study physician during the month prior to the Screening Period. Subject must have a technically adequate baseline cardiac magnetic resonance imaging (MRI). Exclusion Criteria: Subject has previously been on active vitamin D therapy within the four weeks prior to the Screening Period Pregnant or lactating females Subject is expected to initiate renal replacement therapy within one year Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids) Subject had clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as either hospitalization for myocardial infarction (MI) or unstable angina; new onset angina with positive functional study or coronary angiogram revealing stenosis; or coronary revascularization procedure. Subject had major cardiac valve abnormality linked with LVH and/or diastolic dysfunction, defined as either aortic valve area ≤ 1.5 cm^2 or a mean gradient of > 20 mmHg; or regurgitation lesions; more than moderate mitral regurgitation, or more than moderate aortic regurgitation. Subject had asymmetric septal hypertrophy defined as septal wall thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram. Subject had a severe cerebrovascular accident (CVA) within the last 3 months (e.g., hemorrhagic) prior to screening. Subject had full remission from a malignancy for less than 1 year except completely excised non-melanoma skin cancer (e.g., basal or squamous carcinoma) or any history of bone metastasis. Subject had comorbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ann Eldred, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 8062
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Site Reference ID/Investigator# 8867
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
Site Reference ID/Investigator# 8864
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Site Reference ID/Investigator# 7257
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Site Reference ID/Investigator# 7727
City
Denver
State/Province
Colorado
ZIP/Postal Code
80230
Country
United States
Facility Name
Site Reference ID/Investigator# 8861
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Site Reference ID/Investigator# 7260
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 7725
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Site Reference ID/Investigator# 7824
City
Tampa
State/Province
Florida
ZIP/Postal Code
33614
Country
United States
Facility Name
Site Reference ID/Investigator# 18882
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Site Reference ID/Investigator# 7823
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Site Reference ID/Investigator# 7249
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
Site Reference ID/Investigator# 7816
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States
Facility Name
Site Reference ID/Investigator# 18881
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Site Reference ID/Investigator# 7817
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Site Reference ID/Investigator# 7245
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Site Reference ID/Investigator# 7248
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Site Reference ID/Investigator# 8868
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Site Reference ID/Investigator# 7828
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Site Reference ID/Investigator# 14442
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131-3403
Country
United States
Facility Name
Site Reference ID/Investigator# 6567
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Site Reference ID/Investigator# 7262
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1045
Country
United States
Facility Name
Site Reference ID/Investigator# 7826
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Site Reference ID/Investigator# 8865
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Site Reference ID/Investigator# 7261
City
Houston
State/Province
Texas
ZIP/Postal Code
77004
Country
United States
Facility Name
Site Reference ID/Investigator# 8058
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
Site Reference ID/Investigator# 7830
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Site Reference ID/Investigator# 7825
City
Murray
State/Province
Utah
ZIP/Postal Code
84157-7000
Country
United States
Facility Name
Site Reference ID/Investigator# 8866
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Facility Name
Site Reference ID/Investigator# 7263
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22033
Country
United States
Facility Name
Site Reference ID/Investigator# 8493
City
Adelaide
ZIP/Postal Code
5000
Country
Australia
Facility Name
Site Reference ID/Investigator# 8506
City
Liverpool
ZIP/Postal Code
2170
Country
Australia
Facility Name
Site Reference ID/Investigator# 8507
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Site Reference ID/Investigator# 9581
City
Reservoir
ZIP/Postal Code
3073
Country
Australia
Facility Name
Site Reference ID/Investigator# 9582
City
Richmond
ZIP/Postal Code
3121
Country
Australia
Facility Name
Site Reference ID/Investigator# 8500
City
Westmead
ZIP/Postal Code
2145
Country
Australia
Facility Name
Site Reference ID/Investigator# 8246
City
Prague 4
ZIP/Postal Code
14021
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 8499
City
Prague 6
ZIP/Postal Code
16900
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 8245
City
Prague
ZIP/Postal Code
12808
Country
Czech Republic
Facility Name
Site Reference ID/Investigator# 6692
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Site Reference ID/Investigator# 9723
City
Duesseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Site Reference ID/Investigator# 6630
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Site Reference ID/Investigator# 7268
City
Nettetal
ZIP/Postal Code
41334
Country
Germany
Facility Name
Site Reference ID/Investigator# 6622
City
Wuerzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Site Reference ID/Investigator# 10626
City
Lido di Camaiore
ZIP/Postal Code
55041
Country
Italy
Facility Name
Site Reference ID/Investigator# 8070
City
Naples
ZIP/Postal Code
80131
Country
Italy
Facility Name
Site Reference ID/Investigator# 8060
City
Rome
ZIP/Postal Code
00165
Country
Italy
Facility Name
Site Reference ID/Investigator# 8519
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Site Reference ID/Investigator# 7702
City
Humacao
ZIP/Postal Code
00791
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7269
City
Ponce
ZIP/Postal Code
00717-1322
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7818
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7270
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7712
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 7266
City
Toa Baja
ZIP/Postal Code
00949
Country
Puerto Rico
Facility Name
Site Reference ID/Investigator# 8881
City
Bucharest
ZIP/Postal Code
010731
Country
Romania
Facility Name
Site Reference ID/Investigator# 8518
City
Bucharest
ZIP/Postal Code
022328
Country
Romania
Facility Name
Site Reference ID/Investigator# 8514
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
Site Reference ID/Investigator# 22682
City
Moscow
ZIP/Postal Code
105229
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 8009
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 7251
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 7250
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Site Reference ID/Investigator# 8883
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Site Reference ID/Investigator# 8358
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Site Reference ID/Investigator# 8355
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Site Reference ID/Investigator# 8356
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Site Reference ID/Investigator# 8882
City
Santander (Cantabria)
ZIP/Postal Code
39008
Country
Spain
Facility Name
Site Reference ID/Investigator# 8234
City
Hsin-Chuang City
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 8884
City
Taipei
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 8228
City
Taipei
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 8229
City
Taoyuan
Country
Taiwan
Facility Name
Site Reference ID/Investigator# 8823
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23194491
Citation
Tamez H, Zoccali C, Packham D, Wenger J, Bhan I, Appelbaum E, Pritchett Y, Chang Y, Agarwal R, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Singh B, Zehnder D, Pachika A, Manning WJ, Shah A, Solomon SD, Thadhani R. Vitamin D reduces left atrial volume in patients with left ventricular hypertrophy and chronic kidney disease. Am Heart J. 2012 Dec;164(6):902-9.e2. doi: 10.1016/j.ahj.2012.09.018. Epub 2012 Oct 29.
Results Reference
derived
PubMed Identifier
22337679
Citation
Thadhani R, Appelbaum E, Pritchett Y, Chang Y, Wenger J, Tamez H, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson BT, Andress D, Zhang W, Packham D, Singh B, Zehnder D, Shah A, Pachika A, Manning WJ, Solomon SD. Vitamin D therapy and cardiac structure and function in patients with chronic kidney disease: the PRIMO randomized controlled trial. JAMA. 2012 Feb 15;307(7):674-84. doi: 10.1001/jama.2012.120.
Results Reference
derived
PubMed Identifier
21242674
Citation
Thadhani R, Appelbaum E, Chang Y, Pritchett Y, Bhan I, Agarwal R, Zoccali C, Wanner C, Lloyd-Jones D, Cannata J, Thompson T, Audhya P, Andress D, Zhang W, Ye J, Packham D, Singh B, Zehnder D, Manning WJ, Pachika A, Solomon SD. Vitamin D receptor activation and left ventricular hypertrophy in advanced kidney disease. Am J Nephrol. 2011;33(2):139-49. doi: 10.1159/000323551. Epub 2011 Jan 18.
Results Reference
derived
PubMed Identifier
18591942
Citation
Thadhani R. Targeted ablation of the vitamin D 1alpha-hydroxylase gene: getting to the heart of the matter. Kidney Int. 2008 Jul;74(2):141-3. doi: 10.1038/ki.2008.219.
Results Reference
derived
Links:
URL
http://rxabbvie.com
Description
Related Info

Learn more about this trial

The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4

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