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

PHASE3TerminatedINTERVENTIONAL
Enrollment

12

Participants

Timeline

Start Date

January 31, 2009

Primary Completion Date

May 31, 2009

Study Completion Date

May 31, 2009

Conditions
Chronic Kidney Disease (CKD) Stage 5Hypertrophy, Left Ventricular
Interventions
DRUG

paricalcitol injection 4 mcg/mL

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

DRUG

Placebo Injection 4 mcg/mL

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

Trial Locations (76)

2145

Westmead Hospital - Dept. of Renal Medicine, Sydney

2170

Liverpool Hospital - Renal Unit, Liverpool

3050

Royal Melbourne Hospital - Dept. of Nephrology, Parkville

4102

The Princess Alexandra Hospital - Nephrology Dept., Wooloongabba

11212

Brookdale Physicians Dialysis Associates, Brooklyn

14004

Servicio de Nefrologia - Planta Baja, Córdoba

15562

IASO General - Renal Unit, Athens

20017

Washington Nephrology Associates, LLP, Washington D.C.

20052

Monza

20852

Biolab Research LLC, Rockville

27100

Pavia

28040

Fundacion Jimenez Diaz - Servicio de Nefrologia, Madrid

30329

FMC-NA Central Atlanta, Atlanta

31008

Clinica Universitaria de la Universidad de Navarra, Pamplona

33624

Fresenius Dialysis - Carrollwood, Tampa

34125

Trieste

37212

V.A. Tennessee Valley Healthcare System, Nashville

37923

G. Edward Newman, MD, LLC, Knoxville

40138

Bologna

40210

Gemeinschaftspraxix Karlstrasse, Düsseldorf

41013

Hospital Universitario Virgen del Rocio - Servicio de Nefrologia, Seville

41334

Niren-, Dochdruck und Dialysepraxis, Nettetal

44109

MetroHealth Medical Center, Cleveland

44263

Gemeinschaftspraxis Dialyse, Dortmund

49007

Fresenius Medical Care, Kalamazoo

56403

Papageorgiou General Hospital of Thessaloniki, Thessaloniki

60031

North Suburban Nephrology, Gurnee

60201

Evanston Northwestern Healthcare Corp. - Division of Nephrology, Evanston

60612

University of Illinois at Chicago - Nephrology Research, Chicago

60617

The University of Chicago - Stony Island Dialysis Unit, Chicago

60805

Research By Design, LLC, Evergreen Park

62500

Faculty Hospital Brno, Brno

63110

Washington University School of Medicine - Division of Renal Disease, St Louis

64128

V.A. Medical Center Research, Kansas City

68131

Creighton University Medical Center, Omaha

77099

Southwest Houston Research, Ltd, Houston

78229

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

80002

Western Nephrology and Metabolic bone disease, Arvada

80031

Western Nephrology, Westminster

85027

Arizona Kidney Disease & Hypertension Center, Phoenix

85284

Southwest Kidney Institute, Tempe

90017

National Institute of Clinical Research, Los Angeles

90033

University of Southern California Kidney Center, Los Angeles

91773

North American Research Institute - California Kidney Specialist, San Dimas

93065

Kidney Center of Simi Valley, Simi Valley

93309

National Institute of Clinical Research, Bakersfield

96450

KfH Nierenzentrum, Coburg

97080

Würzburg

123182

City Clinical Hospital #52, Moscow

125284

Moscow City Clinical Hospital named after Botkin, Moscow

127473

Hospital for War Veterans #2, Moscow

400006

Nefromed Dialysis Centre Cluj, Cluj-Napoca

Spitalul Clinic Judetean Cluj - Clinica de Nefrologie, Cluj-Napoca

700503

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

27103-7108

Nephrology Associates, PLLC, Winston-Salem

304 60

FN Pizen Lochotin - Charles University Teaching Hospital, Pizen

120 08

1st LF UK - Nephrology Dept., Prague

140 21

IKEM - Nephrology Dept., Prague

169 00

1st LF UK - Nephrology Dept. Strahov, Prague

40-027

Katowice

90-153

Lodz

70-111

Szczecin

02-006

Warsaw

02-507

Warsaw

00725

Fresenius Medical Care, Caguas

00935

University of Puerto Rico, Rio Piedras

013221

"Spitalul Dr. C. Davila - Clinica de Nefrologie", Bucharest

022328

Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie, Bucharest

07014

Hospital Universitario Son Dureta, Palma de Mallorca

Unknown

Cheng Hsin Rehabilitation Medical Center, Taipei

National Taiwan University Hospital, Taipei

Chang Gung Memorial Hospital, Taoyuan District

Hsin-Jen Hospital, Xinzhuang

CV2 2DX

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

W12 0NN

Hammersmith Hospital, London

M6 8HD

Salford Royal NHS Foundation Trust - Dept. of Nephrology, Salford

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Massachusetts General Hospital

OTHER

collaborator

Harvard University

OTHER

lead

Abbott

INDUSTRY