Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2007-005092-33 | EudraCT Number |
Not provided
Not provided
This study was prematurely terminated due to low enrollment
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| Name | Class |
|---|---|
| Massachusetts General Hospital | OTHER |
| Harvard University | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paricalcitol Injection 4 mcg/mL | Active Comparator | Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis |
|
| Placebo Injection 4 mcg/mL | Placebo Comparator | Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| paricalcitol injection 4 mcg/mL | Drug | Paricalcitol Injection 4 mcg/mL intravenously three times a week during dialysis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
Not provided
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:
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:
Subject has major cardiac valve abnormality linked with left ventricular hypertrophy (LVH) and/or diastolic dysfunction, defined as one of the following:
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
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| Name | Affiliation | Role |
|---|---|---|
| Dennis Andress, MD | Abbott | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Kidney Disease & Hypertension Center | Phoenix | Arizona | 85027 | United States | ||
| Southwest Kidney Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18591942 | Derived | 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. |
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The Screening Period consisted of 3 visits and occurred within 6 weeks prior to participant randomization and enrollment into the Treatment Period of the study. For enrollment, all screening labs and echocardiogram requirements had to be met. Also, a technically adequate cardiac MRI had to be obtained for participant to be randomized into study.
A total of 220 participants were to be randomized in a 1:1 ratio to each treatment group to receive paricalcitol injection or placebo at 75 US and ex-US sites. A stratified randomization scheme was used to ensure balance among treatment groups with respect to country, sex, and baseline Renin Angiotensin-Aldosterone System (RAAS) inhibitor use.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Paricalcitol Injection 4 Mcg/mL | Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. |
| FG001 | Placebo Injection 4 Mcg/mL | Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo Injection 4 mcg/mL | Drug | Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis |
|
|
| 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. |
| 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. | The ratio of peak E-wave velocity to lateral e-wave velocity is a measure of diastolic heart function. | 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 | E-wave deceleration time is a measure of diastolic heart function. | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
| 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. | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| 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. | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| 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. | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| 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. | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| 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. | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| 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 |
| Würzburg | 97080 | Germany |
| IASO General - Renal Unit | Athens | 15562 | Greece |
| Papageorgiou General Hospital of Thessaloniki | Thessaloniki | 56403 | Greece |
| Bologna | 40138 | Italy |
| Monza | 20052 | Italy |
| Pavia | 27100 | Italy |
| Trieste | 34125 | Italy |
| Katowice | 40-027 | Poland |
| Lodz | 90-153 | Poland |
| Szczecin | 70-111 | Poland |
| Warsaw | 02-006 | Poland |
| 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 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paricalcitol Injection 4 Mcg/mL | Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. |
| BG001 | Placebo Injection 4 Mcg/mL | Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
| |||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | cm/sec | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
|
| |||||||||||||||||||
| Primary | 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. | The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug and the Evaluable population (a subset of ITT population and consists of those participants who have completed Week 24 visit). None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | g/m2.7 | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
| ||||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | sec | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
|
| |||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | cm/sec | Baseline, Week 24, and Week 48/Early Termination |
|
| |||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants who were administered at least one dose of study drug. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | sec | Baseline, 24 Weeks, and 48 Weeks/Early Termination |
|
| |||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | nmol/L | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| ||||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | mcg/L | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| ||||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | cm/sec | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| ||||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | mg/L | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
| ||||||||||||||||||||
| Secondary | 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. | The Intent-To-Treat (ITT) population - all randomized participants administered at least one dose of study drug. Results reported are from the early termination visit analysis for the subjects who terminated prematurely. None of the participants completed 24 or 48 weeks. | Posted | Mean | Standard Deviation | ng/L | Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks) |
|
48 weeks
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Paricalcitol Injection 4 Mcg/mL | Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis. | 0 | 6 | 3 | 6 | ||
| EG001 | Placebo Injection 4 Mcg/mL | Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis. | 0 | 6 | 3 | 6 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chills | General disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash papular | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Rash pruritic | Skin and subcutaneous tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | MedDRA (12.0) | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (12.0) | Non-systematic Assessment |
|
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.
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | Abbott | 800-633-9110 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D017379 | Hypertrophy, Left Ventricular |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D006984 | Hypertrophy |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| ID | Term |
|---|---|
| C084656 | paricalcitol |
Not provided
Not provided
Not provided
| Title | Measurements |
|---|---|
|
| >= 60 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Units | Counts |
|---|---|
| Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Units | Counts |
|---|---|
| Participants |
|
|