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

Last updated: January 18, 2012
Sponsor: Abbott
Overall Status: Terminated

Phase

3

Condition

Kidney Disease

Nephropathy

Kidney Failure (Pediatric)

Treatment

N/A

Clinical Study ID

NCT00616902
M10-221
2007-005092-33
  • Ages > 18
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 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:

  • For females, left ventricular (LV) ejection fraction >= 50% and septal wallthickness between 11-17 mm.

  • For males, LV ejection fraction >= 50% and septal wall thickness between 12-18mm.

  • 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 ScreeningPeriod.

  • A technically adequate baseline cardiac magnetic resonance imaging (MRI).

  • If female, subject is not breast feeding or is not pregnant, or is not of childbearingpotential, defined as postmenopausal for at least one year or surgically sterile, oris of childbearing potential and practicing one of the following methods of birthcontrol:

  • Double-barrier method

  • Hormonal contraceptives for at least three months prior to and during study drugadministration

  • Maintains a monogamous relationship with a vasectomized partner

  • Total abstinence from sexual intercourse during the study.

Exclusion

Exclusion Criteria:

  • Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol,doxercalciferol, alfacalcidol) for a total duration greater than three months sincethe start of dialysis.

  • Subject has a history of an allergic reaction or significant sensitivity toparicalcitol or to drugs similar to the study drug.

  • Subject is expected to receive an increased dose of RAAS inhibitor (Angiotensinconverting enzyme inhibitor [ACEi], Angiotensin II receptor blocker [ARB] oraldosterone inhibitor) during the course of the study.

  • Subject has clinically significant coronary artery disease (CAD) within 3 months priorto 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 revealingstenosis; or

  • 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 thanmoderate 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 excisednon-Melanoma skin cancer (e.g. basal or squamous carcinoma) or any history of bonemetastasis.

  • Subject has co-morbid conditions.

  • Subject has received any investigational drug within 30 days prior to study drugadministration or is currently enrolled in another clinical trial.

  • Subject has poorly controlled hypertension.

  • Subject has history of renal artery stenosis, primary aldosteronism orpheochromocytoma

  • Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (excepttopical or inhaled glucocorticoids)

  • Subject is currently receiving immunosuppressant therapy and/or high doses ofglucocorticoids

  • Subject is known to be HIV positive.

  • Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeksprior 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

Study Design

Total Participants: 12
Study Start date:
January 01, 2009
Estimated Completion Date:
May 31, 2009

Connect with a study center

  • Liverpool Hospital - Renal Unit

    Liverpool, New South Wales 2170
    Australia

    Site Not Available

  • Westmead Hospital - Dept. of Renal Medicine

    Sydney, New South Wales 2145
    Australia

    Site Not Available

  • The Princess Alexandra Hospital - Nephrology Dept.

    Wooloongabba, Queensland 4102
    Australia

    Site Not Available

  • Royal Melbourne Hospital - Dept. of Nephrology

    Parkville, Victoria 3050
    Australia

    Site Not Available

  • Faculty Hospital Brno

    Brno, 62500
    Czech Republic

    Site Not Available

  • FN Pizen Lochotin - Charles University Teaching Hospital

    Pizen, 304 60
    Czech Republic

    Site Not Available

  • IKEM - Nephrology Dept.

    Prague 4, 140 21
    Czech Republic

    Site Not Available

  • 1st LF UK - Nephrology Dept.

    Praha 2, 120 08
    Czech Republic

    Site Not Available

  • 1st LF UK - Nephrology Dept. Strahov

    Praha 6, 169 00
    Czech Republic

    Site Not Available

  • KfH Nierenzentrum

    Coburg, 96450
    Germany

    Site Not Available

  • Gemeinschaftspraxis Dialyse

    Dortmund, 44263
    Germany

    Site Not Available

  • Gemeinschaftspraxix Karlstrasse

    Dusseldorf, 40210
    Germany

    Site Not Available

  • Niren-, Dochdruck und Dialysepraxis

    Nettetal, 41334
    Germany

    Site Not Available

  • Wurzburg, 97080
    Germany

    Site Not Available

  • IASO General - Renal Unit

    Athens, 15562
    Greece

    Site Not Available

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 56403
    Greece

    Site Not Available

  • Bologna, 40138
    Italy

    Site Not Available

  • Monza, 20052
    Italy

    Site Not Available

  • Pavia, 27100
    Italy

    Site Not Available

  • Trieste, 34125
    Italy

    Site Not Available

  • Katowice, 40-027
    Poland

    Site Not Available

  • Lodz, 90-153
    Poland

    Site Not Available

  • Szczecin, 70-111
    Poland

    Site Not Available

  • Warszawa, 02-006
    Poland

    Site Not Available

  • Fresenius Medical Care

    Caguas, 00725
    Puerto Rico

    Site Not Available

  • University of Puerto Rico

    Rio Piedras, 00935
    Puerto Rico

    Site Not Available

  • Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie

    Bucuresti, 022328
    Romania

    Site Not Available

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

    Bucuresti, 013221
    Romania

    Site Not Available

  • Nefromed Dialysis Centre Cluj

    Cluj-Napoca, 400006
    Romania

    Site Not Available

  • Spitalul Clinic Judetean Cluj - Clinica de Nefrologie

    Cluj-Napoca, 400006
    Romania

    Site Not Available

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

    Iasi, 700503
    Romania

    Site Not Available

  • City Clinical Hospital #52

    Moscow, 123182
    Russian Federation

    Site Not Available

  • Hospital for War Veterans #2

    Moscow, 127473
    Russian Federation

    Site Not Available

  • Moscow City Clinical Hospital named after Botkin

    Moscow, 125284
    Russian Federation

    Site Not Available

  • Servicio de Nefrologia - Planta Baja

    Cordoba, 14004
    Spain

    Site Not Available

  • Fundacion Jimenez Diaz - Servicio de Nefrologia

    Madrid, 28040
    Spain

    Site Not Available

  • Hospital Universitario Son Dureta

    Palma de Mallorca, 07014
    Spain

    Site Not Available

  • Clinica Universitaria de la Universidad de Navarra

    Pamplona, 31008
    Spain

    Site Not Available

  • Hospital Universitario Virgen del Rocio - Servicio de Nefrologia

    Sevilla, 41013
    Spain

    Site Not Available

  • Hsin-Jen Hospital

    Hsin-Chuang City,
    Taiwan

    Site Not Available

  • Cheng Hsin Rehabilitation Medical Center

    Taipei,
    Taiwan

    Site Not Available

  • National Taiwan University Hospital

    Taipei,
    Taiwan

    Site Not Available

  • Chang Gung Memorial Hospital

    Taoyuan,
    Taiwan

    Site Not Available

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

    Coventry, CV2 2DX
    United Kingdom

    Site Not Available

  • Hammersmith Hospital

    London, W12 0NN
    United Kingdom

    Site Not Available

  • Salford Royal NHS Foundation Trust - Dept. of Nephrology

    Salford, M6 8HD
    United Kingdom

    Site Not Available

  • Arizona Kidney Disease & Hypertension Center

    Phoenix, Arizona 85027
    United States

    Site Not Available

  • Southwest Kidney Institute

    Tempe, Arizona 85284
    United States

    Site Not Available

  • National Institute of Clinical Research

    Bakersfield, California 93309
    United States

    Site Not Available

  • National Institute of Clinical Research

    Los Angeles, California 90017
    United States

    Site Not Available

  • University of Southern California Kidney Center

    Los Angeles, California 90033
    United States

    Site Not Available

  • North American Research Institute - California Kidney Specialist

    San Dimas, California 91773
    United States

    Site Not Available

  • Kidney Center of Simi Valley

    Simi Valley, California 93065
    United States

    Site Not Available

  • Western Nephrology and Metabolic bone disease

    Arvada, Colorado 80002
    United States

    Site Not Available

  • Western Nephrology

    Westminster, Colorado 80031
    United States

    Site Not Available

  • Washington Nephrology Associates, LLP

    Washington, District of Columbia 20017
    United States

    Site Not Available

  • Fresenius Dialysis - Carrollwood

    Tampa, Florida 33624
    United States

    Site Not Available

  • FMC-NA Central Atlanta

    Atlanta, Georgia 30329
    United States

    Site Not Available

  • The University of Chicago - Stony Island Dialysis Unit

    Chicago, Illinois 60617
    United States

    Site Not Available

  • University of Illinois at Chicago - Nephrology Research

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Evanston Northwestern Healthcare Corp. - Division of Nephrology

    Evanston, Illinois 60201
    United States

    Site Not Available

  • Research By Design, LLC

    Evergreen Park, Illinois 60805
    United States

    Site Not Available

  • North Suburban Nephrology

    Gurnee, Illinois 60031
    United States

    Site Not Available

  • Biolab Research LLC

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Fresenius Medical Care

    Kalamazoo, Michigan 49007
    United States

    Site Not Available

  • V.A. Medical Center Research

    Kansas City, Missouri 64128
    United States

    Site Not Available

  • Washington University School of Medicine - Division of Renal Disease

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Creighton University Medical Center

    Omaha, Nebraska 68131
    United States

    Site Not Available

  • Brookdale Physicians Dialysis Associates

    Brooklyn, New York 11212
    United States

    Site Not Available

  • Nephrology Associates, PLLC

    Winston-Salem, North Carolina 27103-7108
    United States

    Site Not Available

  • MetroHealth Medical Center

    Cleveland, Ohio 44109
    United States

    Site Not Available

  • G. Edward Newman, MD, LLC

    Knoxville, Tennessee 37923
    United States

    Site Not Available

  • V.A. Tennessee Valley Healthcare System

    Nashville, Tennessee 37212
    United States

    Site Not Available

  • Southwest Houston Research, Ltd

    Houston, Texas 77099
    United States

    Site Not Available

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

    San Antonio, Texas 78229
    United States

    Site Not Available

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