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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00497146




Registration number
NCT00497146
Ethics application status
Date submitted
3/07/2007
Date registered
6/07/2007
Date last updated
12/03/2013

Titles & IDs
Public title
The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Scientific title
The PRIMO Study: Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Secondary ID [1] 0 0
2007-001689-34
Secondary ID [2] 0 0
M10-030
Universal Trial Number (UTN)
Trial acronym
PRIMO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Kidney Disease 0 0
Left Ventricular Hypertrophy 0 0
Condition category
Condition code
Renal and Urogenital 0 0 0 0
Kidney disease
Renal and Urogenital 0 0 0 0
Other renal and urogenital disorders
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - paricalcitol
Treatment: Drugs - placebo

Experimental: Paricalcitol - 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.

Placebo Comparator: Placebo - 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.


Treatment: Drugs: paricalcitol
2 µg capsule

Treatment: Drugs: placebo
placebo capsule

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline to 48 weeks
Secondary outcome [1] 0 0
Change in Diastolic Mitral Annular Relaxation Velocity (E') - Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.
Timepoint [1] 0 0
Baseline to 48 weeks
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline to 48 weeks
Secondary outcome [3] 0 0
Change in E-wave Deceleration Time (DT) - E-wave deceleration time (DT) is a measure of diastolic function.
Timepoint [3] 0 0
Baseline to 48 weeks
Secondary outcome [4] 0 0
Change in Isovolumetric Relaxation Time (IVRT) - Isovolumetric relaxation time (IVRT) is a measure of diastolic function.
Timepoint [4] 0 0
Baseline to 48 weeks
Secondary outcome [5] 0 0
Change in Left Atrial Volume - Left atrial volume is a measure of diastolic function.
Timepoint [5] 0 0
Baseline to 48 weeks
Secondary outcome [6] 0 0
Change in Plasma Triiodothyronine (T3) - Plasma triiodothyronine (T3) is a biological and inflammatory marker.
Timepoint [6] 0 0
Baseline to 48 weeks
Secondary outcome [7] 0 0
Change in Interleukin-6 (IL-6) - Interleukin-6 (IL-6) is a biological and inflammatory marker.
Timepoint [7] 0 0
Baseline to 48 weeks
Secondary outcome [8] 0 0
Change in Troponin-T - Troponin-T is a biological and inflammatory marker.
Timepoint [8] 0 0
Baseline to 48 weeks
Secondary outcome [9] 0 0
Change in B-type Natriuretic Peptide (BNP) - B-type natriuretic peptide (BNP) is a biological and inflammatory marker.
Timepoint [9] 0 0
Baseline to 48 weeks
Secondary outcome [10] 0 0
Change in High Sensitivity C-reactive Protein (hsCRP) - High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.
Timepoint [10] 0 0
Baseline to 48 weeks
Secondary outcome [11] 0 0
Change in Progression of Thoraco-abdominal Aortic Plaque Volume - Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.
Timepoint [11] 0 0
Baseline to 48 weeks
Secondary outcome [12] 0 0
Change in Progression of Thoraco-abdominal Aortic Wall Volume - Change from baseline to Week 48 in thoraco-abdominal aortic wall volume
Timepoint [12] 0 0
Baseline to 48 weeks
Secondary outcome [13] 0 0
Change in Progression of Aortic Compliance - Change from baseline to Week 48 in aortic compliance.
Timepoint [13] 0 0
Baseline to 48 weeks
Secondary outcome [14] 0 0
Change in Progression of Left Ventricular End-systolic Volume Index - Change from baseline to Week 48 in left ventricular end-systolic volume index.
Timepoint [14] 0 0
Baseline to 48 weeks
Secondary outcome [15] 0 0
Change in Progression of Left Ventricular End-diastolic Volume Index - Change from baseline to Week 48 in left ventricular end-diastolic volume index.
Timepoint [15] 0 0
Baseline to 48 weeks
Secondary outcome [16] 0 0
Change in Progression of Left Ventricular Ejection Fraction - Change from baseline to Week 48 in left ventricular ejection fraction.
Timepoint [16] 0 0
Baseline to 48 weeks

Eligibility
Key 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).
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site Reference ID/Investigator# 8493 - Adelaide
Recruitment hospital [2] 0 0
Site Reference ID/Investigator# 8506 - Liverpool
Recruitment hospital [3] 0 0
Site Reference ID/Investigator# 8507 - Parkville
Recruitment hospital [4] 0 0
Site Reference ID/Investigator# 9581 - Reservoir
Recruitment hospital [5] 0 0
Site Reference ID/Investigator# 9582 - Richmond
Recruitment hospital [6] 0 0
Site Reference ID/Investigator# 8500 - Westmead
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
2170 - Liverpool
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
3073 - Reservoir
Recruitment postcode(s) [5] 0 0
3121 - Richmond
Recruitment postcode(s) [6] 0 0
2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Idaho
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Maryland
Country [8] 0 0
United States of America
State/province [8] 0 0
Massachusetts
Country [9] 0 0
United States of America
State/province [9] 0 0
Michigan
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
Nebraska
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Tennessee
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Utah
Country [17] 0 0
United States of America
State/province [17] 0 0
Virginia
Country [18] 0 0
Czech Republic
State/province [18] 0 0
Prague 4
Country [19] 0 0
Czech Republic
State/province [19] 0 0
Prague 6
Country [20] 0 0
Czech Republic
State/province [20] 0 0
Prague
Country [21] 0 0
Germany
State/province [21] 0 0
Dortmund
Country [22] 0 0
Germany
State/province [22] 0 0
Duesseldorf
Country [23] 0 0
Germany
State/province [23] 0 0
Luebeck
Country [24] 0 0
Germany
State/province [24] 0 0
Nettetal
Country [25] 0 0
Germany
State/province [25] 0 0
Wuerzburg
Country [26] 0 0
Italy
State/province [26] 0 0
Lido di Camaiore
Country [27] 0 0
Italy
State/province [27] 0 0
Naples
Country [28] 0 0
Italy
State/province [28] 0 0
Rome
Country [29] 0 0
Poland
State/province [29] 0 0
Lodz
Country [30] 0 0
Puerto Rico
State/province [30] 0 0
Humacao
Country [31] 0 0
Puerto Rico
State/province [31] 0 0
Ponce
Country [32] 0 0
Puerto Rico
State/province [32] 0 0
Rio Piedras
Country [33] 0 0
Puerto Rico
State/province [33] 0 0
San Juan
Country [34] 0 0
Puerto Rico
State/province [34] 0 0
Toa Baja
Country [35] 0 0
Romania
State/province [35] 0 0
Bucharest
Country [36] 0 0
Romania
State/province [36] 0 0
Iasi
Country [37] 0 0
Russian Federation
State/province [37] 0 0
Moscow
Country [38] 0 0
Spain
State/province [38] 0 0
Barcelona
Country [39] 0 0
Spain
State/province [39] 0 0
Madrid
Country [40] 0 0
Spain
State/province [40] 0 0
Santander (Cantabria)
Country [41] 0 0
Taiwan
State/province [41] 0 0
Hsin-Chuang City
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taipei
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Coventry

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie (prior sponsor, Abbott)
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Massachusetts General Hospital
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT00497146
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ann Eldred, MD
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications