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The PRIMO Study-Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Chronic Kidney Disease Stage 3B/4
This study is currently recruiting participants.
Verified by Abbott, September 2008
Sponsors and Collaborators: Abbott
Massachusetts General Hospital
Harvard University
Information provided by: Abbott
ClinicalTrials.gov Identifier: NCT00497146
  Purpose

To investigate the effects of paricalcitol capsules on changes on cardiac structure and function in subjects with Stage 3B/4 Chronic Kidney Disease who have left ventricular hypertrophy


Condition Intervention Phase
Chronic Kidney Disease
Left Ventricular Hypertrophy
Drug: paricalcitol
Drug: placebo
Phase III

MedlinePlus related topics: Kidney Failure
Drug Information available for: 19-Nor-1alpha,25-dihydroxyvitamin D2
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study
Official Title: The PRIMO Study-Paricalcitol Capsules Benefits in Renal Failure Induced Cardiac Morbidity in Chronic Kidney Disease Stage 3B/4

Further study details as provided by Abbott:

Primary Outcome Measures:
  • To investigate the effects of paricalcitol capsules on progression or regression of LVH in subjects with Stage 3B/4 CKD compared to placebo, as assessed by comparing changes in LV Mass Index (LVMI) measured by sequential cardiac MRI [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in diastolic mitral annular relaxation velocity (E') and changes in additional measures of diastolic function (IVRT, E/E', DT). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Changes in biological and inflammatory biomarkers, including plasma triiodothyronine (T3), interleukin-6 (IL-6), troponin-T, B-type natriuretic peptide (BNP) and high sensitivity C-reactive protein (hsCRP). [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
  • Measure: Changes in progression of aortic compliance, left ventricular end-systolic volume index, left ventricular end-diastolic volume index and left ventricular ejection fraction. [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 220
Study Start Date: July 2008
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: paricalcitol
2 mcg capsule
2: Placebo Comparator Drug: placebo
placebo capsule

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent
  • Estimated GFR between 15-60 ml/min/1.73 m2
  • Serum iPTH value between 50-300 pg/mL
  • Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L)
  • Phosphorous level <= 5.2 mg/dL (1.68 mmol/L)
  • Serum albumin >= 3.0 g/dL (30 g/L)
  • Echocardiogram results of:

    • Females: LV ejection fraction >/= 50% and septal wall thickness between 12-15 mm; and,
    • Males: LV ejection fraction >/= 50% and septal wall thickness between 13-16 mm
  • The subject must have been receiving optimal medical management of left ventricular hypertrophy (LVF) and CKD, including appropriate use of RAAS inhibitors (ACEi, ARB or aldosterone inhibitor) if indicated by the subject's medical condition. If the subject is receiving RAAS inhibitors the dose must have been stable for greater than one month prior to the Screening Period. However, the subject may have switched to different brands but at equivalent doses as determined by the study physician during the month prior to the Screening Period.
  • Subject must have a technically adequate baseline cardiac MRI.

Exclusion Criteria:

  • Subject has previously been on prescription-based vitamin D therapy within the four weeks prior to the Screening Period
  • Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug
  • Pregnant or lactating females
  • Subject is expected to initiate renal replacement therapy within one year
  • Subject is expected to receive a new or increased dose of RAAS inhibitor during the course of the study
  • Subject has clinically significant coronary artery disease (CAD) within the previous 3 months, defined as one of the following:

    • Hospitalization for 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 LVH and/or diastolic dysfunction, defined as one of the following:

    • Aortic valve area <= 1.5 cm2 or a mean gradient of > 20 mm Hg; 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 previous 3 months (e.g., hemorrhagic)
  • Full remission from a malignancy for less than one year except completely excised non-Melanoma skin cancer or any history of bone metastasis
  • Subject has co-morbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than 1 year
  • Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial
  • Subject has a history of active kidney stones within the previous 2 years
  • 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 (non-maintenance therapy) of steroids
  • Subject has had acute renal failure within the previous 12 weeks
  • 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 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 kilograms)
  • Subject has had a liver or kidney transplant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00497146

Contacts
Contact: Anne Kavanaugh 1-847-938-1722 anne.kavanaugh@abbott.com
Contact: Dennis Andress, MD 1-847-936-3555 dennis.andress@abbott.com

  Show 84 Study Locations
Sponsors and Collaborators
Abbott
Massachusetts General Hospital
Harvard University
Investigators
Principal Investigator: Ravi Thadhani, MD, MPH Massachusetts General Hospital, Harvard Medical School
  More Information

Publications indexed to this study:
Responsible Party: Abbott ( Dennis Andress, MD )
Study ID Numbers: M10-030, EudraCT 2007-001689-34
Study First Received: July 3, 2007
Last Updated: October 29, 2008
ClinicalTrials.gov Identifier: NCT00497146  
Health Authority: United States: Food and Drug Administration

Keywords provided by Abbott:
Chronic Kidney Disease (CKD)
Left Ventricular Hypertrophy (LVH)
Zemplar
paricalcitol
PRIMO
Chronic Kidney Disease Stage 3B/4

Study placed in the following topic categories:
Pathological Conditions, Anatomical
Hypertrophy, Left Ventricular
Renal Insufficiency
Heart Diseases
Kidney Failure, Chronic
Ergocalciferols
Hypertrophy
Vitamin D
Urologic Diseases
Renal Insufficiency, Chronic
Kidney Diseases
Cardiomegaly
Kidney Failure

Additional relevant MeSH terms:
Growth Substances
Vitamins
Physiological Effects of Drugs
Bone Density Conservation Agents
Cardiovascular Diseases
Micronutrients
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009