Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5. - PRIMO II

• Conditions: Stage 5 Chronic Kidney Disease (CKD) in subjects receiving hemodialysis who have Left Ventricular Hypertrophy (LVH); MedDRA version: 14.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 100000004857; MedDRA version: 14.1Level: PTClassification code 10049773Term: Left ventricular hypertrophySystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2007-005092-33-IT
• Lead Sponsor: Abbott GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-06
• Last Update Posted: 7 January 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 220

Inclusion Criteria

1.Subjects has voluntarily signed and dated an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), after the nature of the study has been explained and the subject has had the opportunity to ask questions. The informed consent must be signed before any study-specific procedures are performed. 2.Male or female subjects  18 years. 3.Stage 5 CKD receiving chronic hemodialysis three times per week for  3 months and  12 months from date of Randomization (Day 1). 4.For entry into the Treatment Period the subject must satisfy the following criteria based on the Screening laboratory values: ●Serum 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). 5.For entry into the Treatment Period the subject must satisfy the following criteria based on the Screening echocardiogram: ●For females, LV ejection fraction  50% and septal wall thickness between 11-17 mm; and, ●For males, LV ejection fraction  50% and septal wall thickness between 12 18 mm. 6.If the subject is receiving RAAS inhibitors, the dose must have been stable for greater than one month prior to the Screening Period. 7.Subject must have a technically adequate baseline cardiac MRI. 8.If female, subject is not breast feeding or is not pregnant (verified by negative serum pregnancy test prior to the Treatment Period); or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy); or is of childbearing potential and practicing one of the following methods of birth control: ●Double-barrier method (any two of the following: condoms, contraceptive sponge, diaphragm, vaginal ring with spermicidal jellies or creams, or intrauterine device [IUD]) ●Hormonal contraceptives (oral, parenteral, or transdermal) 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 (minimum one complete menstrual cycle prior to study start)
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Subject has been on active vitamin D therapy (e.g., calcitriol, paricalcitol, doxercalciferol, alfacalcidol) for a total duration greater than three months since the start of dialysis. 2.Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug (i.e., vitamin D or vitamin D related compounds). 3.Subject is expected to receive an increased dose of RAAS inhibitor (ACEi, ARB or aldosterone inhibitor) during the course of the study. 4.Subject has clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, 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. 5.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 mmHg; or ●Regurgitation lesions; more than moderate mitral regurgitation or more than moderate aortic regurgitation. 6.Subject has asymmetric septal hypertrophy defined as septal wall thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram. 7.Subject has had a severe cerebrovascular accident (CVA) within the last three months (e.g., hemorrhagic) prior to screening. 8.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. 9.Subject has co-morbid conditions (e.g., advanced malignancy, advanced liver disease) with a life expectancy less than one year. 10.Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial. 11.Subject has poorly controlled hypertension (systolic blood pressure > 180 mmHg and/or diastolic blood pressure > 110 mmHg) at the Screening Visit (confirmed by repeat). 12.Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma. 13.Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids), or other drugs that may affect calcium or bone metabolism, other than aluminum, calcium and non-calcium containing phosphate binders or female subjects on stable (same dose and product for three months) estrogen and/or progestin therapy. 14.Subject is currently receiving immunosuppressant therapy and/or high doses (non maintenance therapy) of glucocorticoids (> 5 mg/day of prednisone or equivalent). 15.Subject is known to be HIV positive. 16.Use of known inhibitors (i.e., ketoconazole) or inducers (i.e., carbamazepine) of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration. 17.Subject is contraindicated for the MRI examination (i.e., pacemaker). 18.For any reason, subject is considered by the Investigator to be an unsuitable candidate to receive paricalcitol injection or is put at risk by study procedures. 19.Subject has a history of drug or alcohol abuse within six months prior to screening. 20.Subject weighs more than 340 pounds (154 kilograms). 21.Subject has had a liver transplant.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified