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

Stopped early · Phase 3 · Has a placebo group

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

In brief

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).

Key facts

Study ID

NCT00616902

Run by

Abbott

People needed

12

Starts

2009-01-01

Expected to finish

2009-05-01

Last updated by the study team

2012-01-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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)

Where it is running

• Southwest Kidney Institute — Tempe, Arizona, United States
• National Institute of Clinical Research — Bakersfield, California, United States
• National Institute of Clinical Research — Los Angeles, California, United States
• University of Southern California Kidney Center — Los Angeles, California, United States
• North American Research Institute - California Kidney Specialist — San Dimas, California, United States
• Kidney Center of Simi Valley — Simi Valley, California, United States
• Western Nephrology and Metabolic bone disease — Arvada, Colorado, United States
• Western Nephrology — Westminster, Colorado, United States
• Washington Nephrology Associates, LLP — Washington D.C., District of Columbia, United States
• Fresenius Dialysis - Carrollwood — Tampa, Florida, United States
• FMC-NA Central Atlanta — Atlanta, Georgia, United States
• University of Illinois at Chicago - Nephrology Research — Chicago, Illinois, United States
• The University of Chicago - Stony Island Dialysis Unit — Chicago, Illinois, United States
• Evanston Northwestern Healthcare Corp. - Division of Nephrology — Evanston, Illinois, United States
• Research By Design, LLC — Evergreen Park, Illinois, United States
• North Suburban Nephrology — Gurnee, Illinois, United States
• Biolab Research LLC — Rockville, Maryland, United States
• Fresenius Medical Care — Kalamazoo, Michigan, United States
• V.A. Medical Center Research — Kansas City, Missouri, United States
• Washington University School of Medicine - Division of Renal Disease — St Louis, Missouri, United States
• Creighton University Medical Center — Omaha, Nebraska, United States
• Brookdale Physicians Dialysis Associates — Brooklyn, New York, United States
• Nephrology Associates, PLLC — Winston-Salem, North Carolina, United States
• MetroHealth Medical Center — Cleveland, Ohio, United States
• Arizona Kidney Disease & Hypertension Center — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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