AzTrials
AzTrials

Chronic Kidney DiseasePhase 3PRIMONCT00497146

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

A Phase 3 study testing paricalcitol in people with Chronic Kidney Disease and Left Ventricular Hypertrophy, run by AbbVie (prior sponsor, Abbott) at 71 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
paricalcitol
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
227 participants
Where
71 sitesin 12 countries
Study dates
Feb 2008to Mar 2012
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

71 sites in 12 countries.

71 sites in 12 countries

United States30 sites

  • Site Reference ID/Investigator# 7826

    Allentown, Pennsylvania, 18103

  • Site Reference ID/Investigator# 7816

    Bethesda, Maryland, 20814

  • Site Reference ID/Investigator# 8865

    Chattanooga, Tennessee, 37404

  • Site Reference ID/Investigator# 7823

    Chicago, Illinois, 60617

  • Site Reference ID/Investigator# 7727

    Denver, Colorado, 80230

  • Site Reference ID/Investigator# 7245

    Detroit, Michigan, 48202

  • Site Reference ID/Investigator# 7249

    Evergreen Park, Illinois, 60805

  • Site Reference ID/Investigator# 7263

    Fairfax, Virginia, 22033

  • Site Reference ID/Investigator# 7261

    Houston, Texas, 77004

  • Site Reference ID/Investigator# 8058

    Houston, Texas, 77099

  • Site Reference ID/Investigator# 8868

    Kansas City, Missouri, 64128

  • Site Reference ID/Investigator# 18882

    Meridian, Idaho, 83642

  • Site Reference ID/Investigator# 8861

    Miami, Florida, 33136

  • Site Reference ID/Investigator# 7825

    Murray, Utah, 84157-7000

  • Site Reference ID/Investigator# 14442

    Omaha, Nebraska, 68131-3403

  • Site Reference ID/Investigator# 7260

    Orlando, Florida, 32806

  • Site Reference ID/Investigator# 8062

    Phoenix, Arizona, 85012

  • Site Reference ID/Investigator# 8866

    Provo, Utah, 84604

  • Site Reference ID/Investigator# 18881

    Rockville, Maryland, 20852

  • Site Reference ID/Investigator# 7248

    Royal Oak, Michigan, 48073

  • Site Reference ID/Investigator# 7830

    San Antonio, Texas, 78229

  • Site Reference ID/Investigator# 8864

    San Diego, California, 92123

  • Site Reference ID/Investigator# 7257

    San Dimas, California, 91773

  • Site Reference ID/Investigator# 7817

    Springfield, Massachusetts, 01107

  • Site Reference ID/Investigator# 7828

    St Louis, Missouri, 63110

  • Site Reference ID/Investigator# 7725

    Tampa, Florida, 33603

  • Site Reference ID/Investigator# 7824

    Tampa, Florida, 33614

  • Site Reference ID/Investigator# 8867

    Tempe, Arizona, 85284

  • Site Reference ID/Investigator# 6567

    Winston-Salem, North Carolina, 27103

  • Site Reference ID/Investigator# 7262

    Winston-Salem, North Carolina, 27157-1045

Other trials in United States

Australia6 sites

  • Site Reference ID/Investigator# 8493

    Adelaide, 5000

  • Site Reference ID/Investigator# 8506

    Liverpool, 2170

  • Site Reference ID/Investigator# 8507

    Parkville, 3050

  • Site Reference ID/Investigator# 9581

    Reservoir, 3073

  • Site Reference ID/Investigator# 9582

    Richmond, 3121

  • Site Reference ID/Investigator# 8500

    Westmead, 2145

Other trials in Australia

Puerto Rico6 sites

  • Site Reference ID/Investigator# 7702

    Humacao, 00791

  • Site Reference ID/Investigator# 7269

    Ponce, 00717-1322

  • Site Reference ID/Investigator# 7818

    Rio Piedras, 00935

  • Site Reference ID/Investigator# 7270

    San Juan, 00909

  • Site Reference ID/Investigator# 7712

    San Juan, 00918

  • Site Reference ID/Investigator# 7266

    Toa Baja, 00949

Other trials in Puerto Rico

Germany5 sites

  • Site Reference ID/Investigator# 6692

    Dortmund, 44263

  • Site Reference ID/Investigator# 9723

    Düsseldorf, 40210

  • Site Reference ID/Investigator# 6630

    Lübeck, 23538

  • Site Reference ID/Investigator# 7268

    Nettetal, 41334

  • Site Reference ID/Investigator# 6622

    Würzburg, 97080

Other trials in Germany

Spain5 sites

  • Site Reference ID/Investigator# 8883

    Barcelona, 08003

  • Site Reference ID/Investigator# 8358

    Barcelona, 08035

  • Site Reference ID/Investigator# 8355

    Madrid, 28007

  • Site Reference ID/Investigator# 8356

    Madrid, 28041

  • Site Reference ID/Investigator# 8882

    Santander (Cantabria), 39008

Other trials in Spain

Russia4 sites

  • Site Reference ID/Investigator# 22682

    Moscow, 105229

  • Site Reference ID/Investigator# 8009

    Moscow, 123182

  • Site Reference ID/Investigator# 7251

    Moscow, 125284

  • Site Reference ID/Investigator# 7250

    Moscow, 127473

Other trials in Russia

Taiwan4 sites

  • Site Reference ID/Investigator# 8884

    Taipei, 10002

  • Site Reference ID/Investigator# 8228

    Taipei

  • Site Reference ID/Investigator# 8229

    Taoyuan

  • Site Reference ID/Investigator# 8234

    Xinzhuang

Other trials in Taiwan

Czechia3 sites

  • Site Reference ID/Investigator# 8245

    Prague, 12808

  • Site Reference ID/Investigator# 8246

    Prague, 14021

  • Site Reference ID/Investigator# 8499

    Prague, 16900

Other trials in Czechia

Italy3 sites

  • Site Reference ID/Investigator# 10626

    Lido di Camaiore, 55041

  • Site Reference ID/Investigator# 8070

    Naples, 80131

  • Site Reference ID/Investigator# 8060

    Rome, 00165

Other trials in Italy

Romania3 sites

  • Site Reference ID/Investigator# 8881

    Bucharest, 010731

  • Site Reference ID/Investigator# 8518

    Bucharest, 022328

  • Site Reference ID/Investigator# 8514

    Iași, 700503

Other trials in Romania

Poland1 site

  • Site Reference ID/Investigator# 8519

    Lodz, 90-153

Other trials in Poland

United Kingdom1 site

  • Site Reference ID/Investigator# 8823

    Coventry, CV2 2DX

Other trials in United Kingdom

About this study

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

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).

Read the 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.

Being tested
paricalcitol, placebo
Keywords
paricalcitol, Zemplar, PRIMO, Chronic Kidney Disease Stage 3B/4
Medical subject headings
Renal Insufficiency, Chronic, Hypertrophy, Left Ventricular

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • paricalcitolDrug

    Also called ABT-358, Zemplar

    2 µg capsule

  • placeboDrug

    placebo capsule

Study groups in NCT00497146
Study groupRoleWhat they receive
ParicalcitolExperimentalParticipants 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.
Receives: Drug: paricalcitol
PlaceboPlacebo comparatorParticipants 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.
Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 48 weeks

Secondary outcomes (16)

  1. Change in Diastolic Mitral Annular Relaxation Velocity (E')

    Diastolic mitral annular relaxation velocity (lateral E wave velocity; E') is a measure of diastolic function.

    Measured: Baseline to 48 weeks

  2. 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.

    Measured: Baseline to 48 weeks

  3. Change in E-wave Deceleration Time (DT)

    E-wave deceleration time (DT) is a measure of diastolic function.

    Measured: Baseline to 48 weeks

  4. Change in Isovolumetric Relaxation Time (IVRT)

    Isovolumetric relaxation time (IVRT) is a measure of diastolic function.

    Measured: Baseline to 48 weeks

  5. Change in Left Atrial Volume

    Left atrial volume is a measure of diastolic function.

    Measured: Baseline to 48 weeks

  6. Change in Plasma Triiodothyronine (T3)

    Plasma triiodothyronine (T3) is a biological and inflammatory marker.

    Measured: Baseline to 48 weeks

  7. Change in Interleukin-6 (IL-6)

    Interleukin-6 (IL-6) is a biological and inflammatory marker.

    Measured: Baseline to 48 weeks

  8. Change in Troponin-T

    Troponin-T is a biological and inflammatory marker.

    Measured: Baseline to 48 weeks

  9. Change in B-type Natriuretic Peptide (BNP)

    B-type natriuretic peptide (BNP) is a biological and inflammatory marker.

    Measured: Baseline to 48 weeks

  10. Change in High Sensitivity C-reactive Protein (hsCRP)

    High sensitivity C-reactive protein (hsCRP) is a biological and inflammatory marker.

    Measured: Baseline to 48 weeks

  11. Change in Progression of Thoraco-abdominal Aortic Plaque Volume

    Change from baseline to Week 48 in thoraco-abdominal aortic plaque volume.

    Measured: Baseline to 48 weeks

  12. Change in Progression of Thoraco-abdominal Aortic Wall Volume

    Change from baseline to Week 48 in thoraco-abdominal aortic wall volume

    Measured: Baseline to 48 weeks

  13. Change in Progression of Aortic Compliance

    Change from baseline to Week 48 in aortic compliance.

    Measured: Baseline to 48 weeks

  14. Change in Progression of Left Ventricular End-systolic Volume Index

    Change from baseline to Week 48 in left ventricular end-systolic volume index.

    Measured: Baseline to 48 weeks

  15. Change in Progression of Left Ventricular End-diastolic Volume Index

    Change from baseline to Week 48 in left ventricular end-diastolic volume index.

    Measured: Baseline to 48 weeks

  16. Change in Progression of Left Ventricular Ejection Fraction

    Change from baseline to Week 48 in left ventricular ejection fraction.

    Measured: Baseline to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2007 (estimated)
  2. Study startFeb 2008
  3. Primary completionSep 2010
  4. Study completionMar 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
227 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00497146
Sponsor's protocol ID
M10-030
Other IDs
2007-001689-34
Acronym
PRIMO
Status last verified
Mar 2013
First submitted
3 Jul 2007
Last updated
12 Mar 2013
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23194491

  • 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.

    PubMed 22337679

  • 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.

    PubMed 21242674

  • 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.

    PubMed 18591942

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing paricalcitol in people with Chronic Kidney Disease and Left Ventricular Hypertrophy, run by AbbVie (prior sponsor, Abbott) at 71 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 71 sites in United States, Australia, Puerto Rico, Germany, Spain and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Dec 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI) (time frame: Baseline to 48 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00497146, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in