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Chronic Kidney Disease (CKD) Stage 5Phase 3PRIMO IINCT00616902

The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

A Phase 3 study testing paricalcitol injection 4 mcg/mL in people with Chronic Kidney Disease (CKD) Stage 5 and Hypertrophy, Left Ventricular, run by Abbott at 76 sites in 13 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
paricalcitol injection 4 mcg/mL
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
76 sitesin 13 countries
Study dates
Jan 2009to May 2009
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

  • Stage 5 CKD receiving chronic hemodialysis three times per week for >= 3 months and <= 12 months from date of Randomization (Day 1).
  • Serum intact parathyroid hormone (iPTH) value between 100-350 pg/mL.
  • Serum calcium level between 8.4-10.5 mg/dL (2.1-2.6 mmol/L).
  • Phosphate < 7 mg/dL.
  • Serum albumin >= 3.0 g/dL (30 g/L).
  • Echocardiogram results:
Show all 15Show fewer
  • For females, left ventricular (LV) ejection fraction >= 50% and septal wall thickness between 11-17 mm.
  • For males, LV ejection fraction >= 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.
  • A technically adequate baseline cardiac magnetic resonance imaging (MRI).
  • If female, subject is not breast feeding or is not pregnant, or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control:
  • Double-barrier method
  • Hormonal contraceptives for at least three months prior to and during study drug administration
  • Maintains a monogamous relationship with a vasectomized partner
  • Total abstinence from sexual intercourse during the study.

Who cannot join

  • Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol, doxercalciferol, alfacalcidol) for a total duration greater than three months since the start of dialysis.
  • Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
  • Subject is expected to receive an increased dose of RAAS inhibitor (Angiotensin converting enzyme inhibitor [ACEi], Angiotensin II receptor blocker [ARB] or aldosterone inhibitor) during the course of the study.
  • Subject has clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as one of the following:
  • Hospitalization for myocardial infarction (MI) or unstable angina; or
  • New onset angina with positive functional study or coronary angiogram revealing stenosis; or
Show all 26Show fewer
  • Coronary revascularization procedure.
  • Subject has major cardiac valve abnormality linked with left ventricular hypertrophy (LVH) and/or diastolic dysfunction, defined as one of the following:
  • Aortic valve area <= 1.5 cm2 or a mean gradient of > 20 mmHg; or
  • Regurgitation lesions; more than moderate mitral regurgitation or more than moderate aortic regurgitation.
  • Subject has asymmetric septal hypertrophy.
  • Subject has had a severe cerebrovascular accident (CVA) within the last three months (e.g., hemorrhagic) prior to screening.
  • Full remission from a malignancy for less than one year except completely excised non-Melanoma skin cancer (e.g. basal or squamous carcinoma) or any history of bone metastasis.
  • Subject has co-morbid conditions.
  • Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial.
  • Subject has poorly controlled hypertension.
  • Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma
  • Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids)
  • Subject is currently receiving immunosuppressant therapy and/or high doses of glucocorticoids
  • Subject is known to be HIV positive.
  • Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration
  • Subject is contraindicated for the MRI examination
  • Investigator considers subject unsuitable for any reason
  • Subject has a history of drug or alcohol abuse within six months prior to screening
  • Subject weighs more than 340 pounds (154 kg)
  • Subject has had a liver transplant

Trial locations and contacts

76 sites in 13 countries.

76 sites in 13 countries

United States29 sites

  • Western Nephrology and Metabolic bone disease

    Arvada, Colorado, 80002

  • FMC-NA Central Atlanta

    Atlanta, Georgia, 30329

  • National Institute of Clinical Research

    Bakersfield, California, 93309

  • Brookdale Physicians Dialysis Associates

    Brooklyn, New York, 11212

  • University of Illinois at Chicago - Nephrology Research

    Chicago, Illinois, 60612

  • The University of Chicago - Stony Island Dialysis Unit

    Chicago, Illinois, 60617

  • MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Evanston Northwestern Healthcare Corp. - Division of Nephrology

    Evanston, Illinois, 60201

  • Research By Design, LLC

    Evergreen Park, Illinois, 60805

  • North Suburban Nephrology

    Gurnee, Illinois, 60031

  • Southwest Houston Research, Ltd

    Houston, Texas, 77099

  • Fresenius Medical Care

    Kalamazoo, Michigan, 49007

  • V.A. Medical Center Research

    Kansas City, Missouri, 64128

  • G. Edward Newman, MD, LLC

    Knoxville, Tennessee, 37923

  • National Institute of Clinical Research

    Los Angeles, California, 90017

  • University of Southern California Kidney Center

    Los Angeles, California, 90033

  • V.A. Tennessee Valley Healthcare System

    Nashville, Tennessee, 37212

  • Creighton University Medical Center

    Omaha, Nebraska, 68131

  • Arizona Kidney Disease & Hypertension Center

    Phoenix, Arizona, 85027

  • Biolab Research LLC

    Rockville, Maryland, 20852

  • The University of Texas - Health Science Center at San Antonio

    San Antonio, Texas, 78229

  • North American Research Institute - California Kidney Specialist

    San Dimas, California, 91773

  • Kidney Center of Simi Valley

    Simi Valley, California, 93065

  • Washington University School of Medicine - Division of Renal Disease

    St Louis, Missouri, 63110

  • Fresenius Dialysis - Carrollwood

    Tampa, Florida, 33624

  • Southwest Kidney Institute

    Tempe, Arizona, 85284

  • Washington Nephrology Associates, LLP

    Washington D.C., District of Columbia, 20017

  • Western Nephrology

    Westminster, Colorado, 80031

  • Nephrology Associates, PLLC

    Winston-Salem, North Carolina, 27103-7108

Other trials in United States

Czechia5 sites

  • Faculty Hospital Brno

    Brno, 62500

  • FN Pizen Lochotin - Charles University Teaching Hospital

    Pizen, 304 60

  • 1st LF UK - Nephrology Dept.

    Prague, 120 08

  • IKEM - Nephrology Dept.

    Prague, 140 21

  • 1st LF UK - Nephrology Dept. Strahov

    Prague, 169 00

Other trials in Czechia

Germany5 sites

  • KfH Nierenzentrum

    Coburg, 96450

  • Gemeinschaftspraxis Dialyse

    Dortmund, 44263

  • Gemeinschaftspraxix Karlstrasse

    Düsseldorf, 40210

  • Niren-, Dochdruck und Dialysepraxis

    Nettetal, 41334

  • Study site

    Würzburg, 97080

Other trials in Germany

Poland5 sites

  • Study site

    Katowice, 40-027

  • Study site

    Lodz, 90-153

  • Study site

    Szczecin, 70-111

  • Study site

    Warsaw, 02-006

  • Study site

    Warsaw, 02-507

Other trials in Poland

Romania5 sites

  • Spitalul "Dr. C. Davila" - Clinica de Nefrologie

    Bucharest, 013221

  • Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie

    Bucharest, 022328

  • Nefromed Dialysis Centre Cluj

    Cluj-Napoca, 400006

  • Spitalul Clinic Judetean Cluj - Clinica de Nefrologie

    Cluj-Napoca, 400006

  • Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie

    Iași, 700503

Other trials in Romania

Spain5 sites

  • Servicio de Nefrologia - Planta Baja

    Córdoba, 14004

  • Fundacion Jimenez Diaz - Servicio de Nefrologia

    Madrid, 28040

  • Hospital Universitario Son Dureta

    Palma de Mallorca, 07014

  • Clinica Universitaria de la Universidad de Navarra

    Pamplona, 31008

  • Hospital Universitario Virgen del Rocio - Servicio de Nefrologia

    Seville, 41013

Other trials in Spain

Australia4 sites

  • Liverpool Hospital - Renal Unit

    Liverpool, New South Wales, 2170

  • Royal Melbourne Hospital - Dept. of Nephrology

    Parkville, Victoria, 3050

  • Westmead Hospital - Dept. of Renal Medicine

    Sydney, New South Wales, 2145

  • The Princess Alexandra Hospital - Nephrology Dept.

    Wooloongabba, Queensland, 4102

Other trials in Australia

Italy4 sites

  • Study site

    Bologna, 40138

  • Study site

    Monza, 20052

  • Study site

    Pavia, 27100

  • Study site

    Trieste, 34125

Other trials in Italy

Taiwan4 sites

  • Cheng Hsin Rehabilitation Medical Center

    Taipei

  • National Taiwan University Hospital

    Taipei

  • Chang Gung Memorial Hospital

    Taoyuan

  • Hsin-Jen Hospital

    Xinzhuang

Other trials in Taiwan

Russia3 sites

  • City Clinical Hospital #52

    Moscow, 123182

  • Moscow City Clinical Hospital named after Botkin

    Moscow, 125284

  • Hospital for War Veterans #2

    Moscow, 127473

Other trials in Russia

United Kingdom3 sites

  • University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW)

    Coventry, CV2 2DX

  • Hammersmith Hospital

    London, W12 0NN

  • Salford Royal NHS Foundation Trust - Dept. of Nephrology

    Salford, M6 8HD

Other trials in United Kingdom

Greece2 sites

  • IASO General - Renal Unit

    Athens, 15562

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56403

Other trials in Greece

Puerto Rico2 sites

  • Fresenius Medical Care

    Caguas, 00725

  • University of Puerto Rico

    Rio Piedras, 00935

Other trials in Puerto Rico

About this study

Official title: Clinical Study Protocol M10-221 The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

Being tested
paricalcitol injection 4 mcg/mL, Placebo Injection 4 mcg/mL
Keywords
Zemplar, paricalcitol, PRIMO II
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.

  • paricalcitol injection 4 mcg/mLDrug

    Also called ABT-358, paricalcitol, Zemplar

    Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis

  • Placebo Injection 4 mcg/mLDrug

    Also called placebo

    Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis

Study groups in NCT00616902
Study groupRoleWhat they receive
Paricalcitol Injection 4 mcg/mLActive comparatorParicalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis
Receives: Drug: paricalcitol injection 4 mcg/mL
Placebo Injection 4 mcg/mLPlacebo comparatorPlacebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Receives: Drug: Placebo Injection 4 mcg/mL

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)

    Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7.

    The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48.

    Measured: Baseline, 24 Weeks, and 48 Weeks/Early Termination

Secondary outcomes (9)

  1. Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.

    Mitral Annular relaxation velocity is a measure of diastolic heart function.

    Measured: Baseline, 24 Weeks, and 48 Weeks/Early Termination

  2. Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.

    Isovolumetric relaxation time is a measure of diastolic heart function.

    Measured: Baseline, 24 Weeks, and 48 Weeks/Early Termination

  3. Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.

    The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.

    Measured: Baseline, Week 24, and Week 48/Early Termination

  4. Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks

    E-wave deceleration time is a measure of diastolic heart function.

    Measured: Baseline, 24 Weeks, and 48 Weeks/Early Termination

  5. Change From Baseline in Biological Marker Triiodothyronine (T3).

    Plasma T3 is a circulating hormone that may have an effect on diastolic heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.

    Measured: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

  6. Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks

    Plasma troponin-t is a marker of heart damage and and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.

    Measured: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

  7. Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks

    Plasma IL-6 is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.

    Measured: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

  8. Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks

    Plasma high sensitivity CRP is a biomarker of inflammation that may have an effect on heart function and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.

    Measured: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

  9. Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)

    Plasma BNP is a product from the heart that becomes elevated with an enlarged heart and its level may be affected by treatment with paricalcitol. The study was terminated early (prior to any subject reaching Week 24). The values are for Baseline and Early Termination only. Each of the 12 randomized subjects terminated at different study weeks; therefore Early Termination cannot be defined as a specific week and varies for different subjects. Of the 12 subjects, 11 had early termination visits and 1 didn't. The final visit week range is 4-16.

    Measured: Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

Timeline

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

  1. First posted15 Feb 2008 (estimated)
  2. Study startJan 2009
  3. Primary completionMay 2009
  4. Study completionMay 2009

Why it stopped: This study was prematurely terminated due to low enrollment

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
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00616902
Sponsor's protocol ID
M10-221
Other IDs
2007-005092-33
Acronym
PRIMO II
Status last verified
Jan 2012
First submitted
5 Feb 2008
Last updated
20 Jan 2012
Data monitoring committee
Yes

Publications

  • 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 injection 4 mcg/mL in people with Chronic Kidney Disease (CKD) Stage 5 and Hypertrophy, Left Ventricular, run by Abbott at 76 sites in 13 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 15 inclusion and 26 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: stopped early, as of the sponsor's last update on 20 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 76 sites in United States, Czechia, Germany, Poland, Romania and 8 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 4 Aug 2010). 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, 24 Weeks, and 48 Weeks/Early Termination). 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 NCT00616902, which also lists 1 linked publication.

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 20 Jan 2012; AzTrials last refreshed its copy on 6 Nov 2026.

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