Study Stopped
This study was prematurely terminated due to low enrollment
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
PRIMO II
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
2 other identifiers
interventional
12
13 countries
76
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jan 2009
Shorter than P25 for phase_3
76 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 5, 2008
CompletedFirst Posted
Study publicly available on registry
February 15, 2008
CompletedStudy Start
First participant enrolled
January 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedResults Posted
Study results publicly available
August 4, 2010
CompletedJanuary 20, 2012
January 1, 2012
4 months
February 5, 2008
May 21, 2010
January 18, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (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.
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Secondary Outcomes (9)
Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.
Baseline, 24 Weeks, and 48 Weeks/Early Termination
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.
Baseline, Week 24, and Week 48/Early Termination
Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Change From Baseline in Biological Marker Triiodothyronine (T3).
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
- +4 more secondary outcomes
Study Arms (2)
Paricalcitol Injection 4 mcg/mL
ACTIVE COMPARATORParicalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis
Placebo Injection 4 mcg/mL
PLACEBO COMPARATORPlacebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Interventions
Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Eligibility Criteria
You may qualify if:
- 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 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.
You may not qualify if:
- 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
- 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.
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbottlead
- Massachusetts General Hospitalcollaborator
- Harvard Universitycollaborator
Study Sites (76)
Arizona Kidney Disease & Hypertension Center
Phoenix, Arizona, 85027, United States
Southwest Kidney Institute
Tempe, Arizona, 85284, United States
National Institute of Clinical Research
Bakersfield, California, 93309, United States
National Institute of Clinical Research
Los Angeles, California, 90017, United States
University of Southern California Kidney Center
Los Angeles, California, 90033, United States
North American Research Institute - California Kidney Specialist
San Dimas, California, 91773, United States
Kidney Center of Simi Valley
Simi Valley, California, 93065, United States
Western Nephrology and Metabolic bone disease
Arvada, Colorado, 80002, United States
Western Nephrology
Westminster, Colorado, 80031, United States
Washington Nephrology Associates, LLP
Washington D.C., District of Columbia, 20017, United States
Fresenius Dialysis - Carrollwood
Tampa, Florida, 33624, United States
FMC-NA Central Atlanta
Atlanta, Georgia, 30329, United States
University of Illinois at Chicago - Nephrology Research
Chicago, Illinois, 60612, United States
The University of Chicago - Stony Island Dialysis Unit
Chicago, Illinois, 60617, United States
Evanston Northwestern Healthcare Corp. - Division of Nephrology
Evanston, Illinois, 60201, United States
Research By Design, LLC
Evergreen Park, Illinois, 60805, United States
North Suburban Nephrology
Gurnee, Illinois, 60031, United States
Biolab Research LLC
Rockville, Maryland, 20852, United States
Fresenius Medical Care
Kalamazoo, Michigan, 49007, United States
V.A. Medical Center Research
Kansas City, Missouri, 64128, United States
Washington University School of Medicine - Division of Renal Disease
St Louis, Missouri, 63110, United States
Creighton University Medical Center
Omaha, Nebraska, 68131, United States
Brookdale Physicians Dialysis Associates
Brooklyn, New York, 11212, United States
Nephrology Associates, PLLC
Winston-Salem, North Carolina, 27103-7108, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
G. Edward Newman, MD, LLC
Knoxville, Tennessee, 37923, United States
V.A. Tennessee Valley Healthcare System
Nashville, Tennessee, 37212, United States
Southwest Houston Research, Ltd
Houston, Texas, 77099, United States
The University of Texas - Health Science Center at San Antonio
San Antonio, Texas, 78229, United States
Liverpool Hospital - Renal Unit
Liverpool, New South Wales, 2170, Australia
Westmead Hospital - Dept. of Renal Medicine
Sydney, New South Wales, 2145, Australia
The Princess Alexandra Hospital - Nephrology Dept.
Wooloongabba, Queensland, 4102, Australia
Royal Melbourne Hospital - Dept. of Nephrology
Parkville, Victoria, 3050, Australia
Faculty Hospital Brno
Brno, 62500, Czechia
FN Pizen Lochotin - Charles University Teaching Hospital
Pizen, 304 60, Czechia
1st LF UK - Nephrology Dept.
Prague, 120 08, Czechia
IKEM - Nephrology Dept.
Prague, 140 21, Czechia
1st LF UK - Nephrology Dept. Strahov
Prague, 169 00, Czechia
KfH Nierenzentrum
Coburg, 96450, Germany
Gemeinschaftspraxis Dialyse
Dortmund, 44263, Germany
Gemeinschaftspraxix Karlstrasse
Düsseldorf, 40210, Germany
Niren-, Dochdruck und Dialysepraxis
Nettetal, 41334, Germany
Unknown Facility
Würzburg, 97080, Germany
IASO General - Renal Unit
Athens, 15562, Greece
Papageorgiou General Hospital of Thessaloniki
Thessaloniki, 56403, Greece
Unknown Facility
Bologna, 40138, Italy
Unknown Facility
Monza, 20052, Italy
Unknown Facility
Pavia, 27100, Italy
Unknown Facility
Trieste, 34125, Italy
Unknown Facility
Katowice, 40-027, Poland
Unknown Facility
Lodz, 90-153, Poland
Unknown Facility
Szczecin, 70-111, Poland
Unknown Facility
Warsaw, 02-006, Poland
Unknown Facility
Warsaw, 02-507, Poland
Fresenius Medical Care
Caguas, 00725, Puerto Rico
University of Puerto Rico
Rio Piedras, 00935, Puerto Rico
Spitalul "Dr. C. Davila" - Clinica de Nefrologie
Bucharest, 013221, Romania
Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie
Bucharest, 022328, Romania
Nefromed Dialysis Centre Cluj
Cluj-Napoca, 400006, Romania
Spitalul Clinic Judetean Cluj - Clinica de Nefrologie
Cluj-Napoca, 400006, Romania
Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie
Iași, 700503, Romania
City Clinical Hospital #52
Moscow, 123182, Russia
Moscow City Clinical Hospital named after Botkin
Moscow, 125284, Russia
Hospital for War Veterans #2
Moscow, 127473, Russia
Servicio de Nefrologia - Planta Baja
Córdoba, 14004, Spain
Fundacion Jimenez Diaz - Servicio de Nefrologia
Madrid, 28040, Spain
Hospital Universitario Son Dureta
Palma de Mallorca, 07014, Spain
Clinica Universitaria de la Universidad de Navarra
Pamplona, 31008, Spain
Hospital Universitario Virgen del Rocio - Servicio de Nefrologia
Seville, 41013, Spain
Cheng Hsin Rehabilitation Medical Center
Taipei, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital
Taoyuan District, Taiwan
Hsin-Jen Hospital
Xinzhuang, Taiwan
University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW)
Coventry, CV2 2DX, United Kingdom
Hammersmith Hospital
London, W12 0NN, United Kingdom
Salford Royal NHS Foundation Trust - Dept. of Nephrology
Salford, M6 8HD, United Kingdom
Related Publications (1)
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.
PMID: 18591942DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study was prematurely terminated due to low enrollment. Only 12 subjects were randomized at 10 investigative sites with none of the subjects completing the study.
Results Point of Contact
- Title
- Global Medical Services
- Organization
- Abbott
Study Officials
- STUDY DIRECTOR
Dennis Andress, MD
Abbott
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2008
First Posted
February 15, 2008
Study Start
January 1, 2009
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
January 20, 2012
Results First Posted
August 4, 2010
Record last verified: 2012-01