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

Primary Purpose

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

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
paricalcitol injection 4 mcg/mL
Placebo Injection 4 mcg/mL
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease (CKD) Stage 5 focused on measuring Zemplar, paricalcitol, PRIMO II

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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.

Exclusion Criteria:

  • 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.
  • 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

Sites / Locations

  • Arizona Kidney Disease & Hypertension Center
  • Southwest Kidney Institute
  • National Institute of Clinical Research
  • National Institute of Clinical Research
  • University of Southern California Kidney Center
  • North American Research Institute - California Kidney Specialist
  • Kidney Center of Simi Valley
  • Western Nephrology and Metabolic bone disease
  • Western Nephrology
  • Washington Nephrology Associates, LLP
  • Fresenius Dialysis - Carrollwood
  • FMC-NA Central Atlanta
  • University of Illinois at Chicago - Nephrology Research
  • The University of Chicago - Stony Island Dialysis Unit
  • Evanston Northwestern Healthcare Corp. - Division of Nephrology
  • Research By Design, LLC
  • North Suburban Nephrology
  • Biolab Research LLC
  • Fresenius Medical Care
  • V.A. Medical Center Research
  • Washington University School of Medicine - Division of Renal Disease
  • Creighton University Medical Center
  • Brookdale Physicians Dialysis Associates
  • Nephrology Associates, PLLC
  • MetroHealth Medical Center
  • G. Edward Newman, MD, LLC
  • V.A. Tennessee Valley Healthcare System
  • Southwest Houston Research, Ltd
  • The University of Texas - Health Science Center at San Antonio
  • Liverpool Hospital - Renal Unit
  • Westmead Hospital - Dept. of Renal Medicine
  • The Princess Alexandra Hospital - Nephrology Dept.
  • Royal Melbourne Hospital - Dept. of Nephrology
  • Faculty Hospital Brno
  • FN Pizen Lochotin - Charles University Teaching Hospital
  • IKEM - Nephrology Dept.
  • 1st LF UK - Nephrology Dept.
  • 1st LF UK - Nephrology Dept. Strahov
  • KfH Nierenzentrum
  • Gemeinschaftspraxis Dialyse
  • Gemeinschaftspraxix Karlstrasse
  • Niren-, Dochdruck und Dialysepraxis
  • IASO General - Renal Unit
  • Papageorgiou General Hospital of Thessaloniki
  • Fresenius Medical Care
  • University of Puerto Rico
  • Spitalul "Dr. C. Davila" - Clinica de Nefrologie
  • Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie
  • Nefromed Dialysis Centre Cluj
  • Spitalul Clinic Judetean Cluj - Clinica de Nefrologie
  • Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie
  • City Clinical Hospital #52
  • Moscow City Clinical Hospital named after Botkin
  • Hospital for War Veterans #2
  • Servicio de Nefrologia - Planta Baja
  • Fundacion Jimenez Diaz - Servicio de Nefrologia
  • Hospital Universitario Son Dureta
  • Clinica Universitaria de la Universidad de Navarra
  • Hospital Universitario Virgen del Rocio - Servicio de Nefrologia
  • Hsin-Jen Hospital
  • Cheng Hsin Rehabilitation Medical Center
  • National Taiwan University Hospital
  • Chang Gung Memorial Hospital
  • University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW)
  • Hammersmith Hospital
  • Salford Royal NHS Foundation Trust - Dept. of Nephrology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Paricalcitol Injection 4 mcg/mL

Placebo Injection 4 mcg/mL

Arm Description

Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
February 5, 2008
Last Updated
January 18, 2012
Sponsor
Abbott
Collaborators
Massachusetts General Hospital, Harvard University
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1. Study Identification

Unique Protocol Identification Number
NCT00616902
Brief Title
The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5
Acronym
PRIMO II
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Terminated
Why Stopped
This study was prematurely terminated due to low enrollment
Study Start Date
January 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
Collaborators
Massachusetts General Hospital, Harvard University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease (CKD) Stage 5, Hypertrophy, Left Ventricular
Keywords
Zemplar, paricalcitol, PRIMO II

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paricalcitol Injection 4 mcg/mL
Arm Type
Active Comparator
Arm Description
Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis
Arm Title
Placebo Injection 4 mcg/mL
Arm Type
Placebo Comparator
Arm Description
Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Intervention Type
Drug
Intervention Name(s)
paricalcitol injection 4 mcg/mL
Other Intervention Name(s)
ABT-358, paricalcitol, Zemplar
Intervention Description
Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis
Intervention Type
Drug
Intervention Name(s)
Placebo Injection 4 mcg/mL
Other Intervention Name(s)
placebo
Intervention Description
Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis
Primary Outcome Measure Information:
Title
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Description
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.
Time Frame
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Secondary Outcome Measure Information:
Title
Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.
Description
Mitral Annular relaxation velocity is a measure of diastolic heart function.
Time Frame
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Title
Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.
Description
Isovolumetric relaxation time is a measure of diastolic heart function.
Time Frame
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Title
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.
Description
The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function.
Time Frame
Baseline, Week 24, and Week 48/Early Termination
Title
Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks
Description
E-wave deceleration time is a measure of diastolic heart function.
Time Frame
Baseline, 24 Weeks, and 48 Weeks/Early Termination
Title
Change From Baseline in Biological Marker Triiodothyronine (T3).
Description
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.
Time Frame
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Title
Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks
Description
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.
Time Frame
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Title
Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks
Description
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.
Time Frame
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Title
Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks
Description
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.
Time Frame
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)
Title
Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)
Description
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.
Time Frame
Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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. Exclusion Criteria: 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. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Andress, MD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Kidney Disease & Hypertension Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85027
Country
United States
Facility Name
Southwest Kidney Institute
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85284
Country
United States
Facility Name
National Institute of Clinical Research
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
National Institute of Clinical Research
City
Los Angeles
State/Province
California
ZIP/Postal Code
90017
Country
United States
Facility Name
University of Southern California Kidney Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
North American Research Institute - California Kidney Specialist
City
San Dimas
State/Province
California
ZIP/Postal Code
91773
Country
United States
Facility Name
Kidney Center of Simi Valley
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Western Nephrology and Metabolic bone disease
City
Arvada
State/Province
Colorado
ZIP/Postal Code
80002
Country
United States
Facility Name
Western Nephrology
City
Westminster
State/Province
Colorado
ZIP/Postal Code
80031
Country
United States
Facility Name
Washington Nephrology Associates, LLP
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20017
Country
United States
Facility Name
Fresenius Dialysis - Carrollwood
City
Tampa
State/Province
Florida
ZIP/Postal Code
33624
Country
United States
Facility Name
FMC-NA Central Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Facility Name
University of Illinois at Chicago - Nephrology Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago - Stony Island Dialysis Unit
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60617
Country
United States
Facility Name
Evanston Northwestern Healthcare Corp. - Division of Nephrology
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Research By Design, LLC
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Facility Name
North Suburban Nephrology
City
Gurnee
State/Province
Illinois
ZIP/Postal Code
60031
Country
United States
Facility Name
Biolab Research LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20852
Country
United States
Facility Name
Fresenius Medical Care
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
V.A. Medical Center Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Washington University School of Medicine - Division of Renal Disease
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton University Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Brookdale Physicians Dialysis Associates
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11212
Country
United States
Facility Name
Nephrology Associates, PLLC
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-7108
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
G. Edward Newman, MD, LLC
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
Facility Name
V.A. Tennessee Valley Healthcare System
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Southwest Houston Research, Ltd
City
Houston
State/Province
Texas
ZIP/Postal Code
77099
Country
United States
Facility Name
The University of Texas - Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Liverpool Hospital - Renal Unit
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
Westmead Hospital - Dept. of Renal Medicine
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
The Princess Alexandra Hospital - Nephrology Dept.
City
Wooloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Royal Melbourne Hospital - Dept. of Nephrology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Faculty Hospital Brno
City
Brno
ZIP/Postal Code
62500
Country
Czech Republic
Facility Name
FN Pizen Lochotin - Charles University Teaching Hospital
City
Pizen
ZIP/Postal Code
304 60
Country
Czech Republic
Facility Name
IKEM - Nephrology Dept.
City
Prague 4
ZIP/Postal Code
140 21
Country
Czech Republic
Facility Name
1st LF UK - Nephrology Dept.
City
Praha 2
ZIP/Postal Code
120 08
Country
Czech Republic
Facility Name
1st LF UK - Nephrology Dept. Strahov
City
Praha 6
ZIP/Postal Code
169 00
Country
Czech Republic
Facility Name
KfH Nierenzentrum
City
Coburg
ZIP/Postal Code
96450
Country
Germany
Facility Name
Gemeinschaftspraxis Dialyse
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Gemeinschaftspraxix Karlstrasse
City
Dusseldorf
ZIP/Postal Code
40210
Country
Germany
Facility Name
Niren-, Dochdruck und Dialysepraxis
City
Nettetal
ZIP/Postal Code
41334
Country
Germany
City
Wurzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
IASO General - Renal Unit
City
Athens
ZIP/Postal Code
15562
Country
Greece
Facility Name
Papageorgiou General Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
City
Bologna
ZIP/Postal Code
40138
Country
Italy
City
Monza
ZIP/Postal Code
20052
Country
Italy
City
Pavia
ZIP/Postal Code
27100
Country
Italy
City
Trieste
ZIP/Postal Code
34125
Country
Italy
City
Katowice
ZIP/Postal Code
40-027
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
City
Warszawa
ZIP/Postal Code
02-006
Country
Poland
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Fresenius Medical Care
City
Caguas
ZIP/Postal Code
00725
Country
Puerto Rico
Facility Name
University of Puerto Rico
City
Rio Piedras
ZIP/Postal Code
00935
Country
Puerto Rico
Facility Name
Spitalul "Dr. C. Davila" - Clinica de Nefrologie
City
Bucuresti
ZIP/Postal Code
013221
Country
Romania
Facility Name
Institut Clinic Fundeni - Clinica Medicine Interna/Nefrologie
City
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
Nefromed Dialysis Centre Cluj
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic Judetean Cluj - Clinica de Nefrologie
City
Cluj-Napoca
ZIP/Postal Code
400006
Country
Romania
Facility Name
Spitalul Clinic "Dr. C. I. Parhon" - Clinica de Nefrologie
City
Iasi
ZIP/Postal Code
700503
Country
Romania
Facility Name
City Clinical Hospital #52
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Moscow City Clinical Hospital named after Botkin
City
Moscow
ZIP/Postal Code
125284
Country
Russian Federation
Facility Name
Hospital for War Veterans #2
City
Moscow
ZIP/Postal Code
127473
Country
Russian Federation
Facility Name
Servicio de Nefrologia - Planta Baja
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Fundacion Jimenez Diaz - Servicio de Nefrologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Son Dureta
City
Palma de Mallorca
ZIP/Postal Code
07014
Country
Spain
Facility Name
Clinica Universitaria de la Universidad de Navarra
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio - Servicio de Nefrologia
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Hsin-Jen Hospital
City
Hsin-Chuang City
Country
Taiwan
Facility Name
Cheng Hsin Rehabilitation Medical Center
City
Taipei
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang Gung Memorial Hospital
City
Taoyuan
Country
Taiwan
Facility Name
University Hospitals Coventry and Warwickshire NHS Trust - University Hospital (UHCW)
City
Coventry
ZIP/Postal Code
CV2 2DX
Country
United Kingdom
Facility Name
Hammersmith Hospital
City
London
ZIP/Postal Code
W12 0NN
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust - Dept. of Nephrology
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18591942
Citation
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.
Results Reference
derived

Learn more about this trial

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

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