EUCTR2007-001689-34-GBActive, not recruitingNot Applicable
The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3/4 - PRIMO I
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Abbott GmbH & Co. KG
- Enrollment
- 220
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects must meet all of the following criteria:
- •1. Subject 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 .³ 18 years.
- •3. For entry into the Treatment Period the subject must satisfy the following criteria
- •based on the Screening laboratory values:
- •? Estimated GFR between 15-60 ml/min/1.73m2 by simplified 4-variable
- •Modification of Diet in Renal Disease (MDRD) formula (this includes a 10%
- •variation in the upper limit of eGFR that will be allowed for the enrollment of
- •subjects, this is to account for variability in the creatinine assay).
- •? 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).
- •? Negative serum pregnancy test for female subjects of childbearing potential.
- •4. 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
- •5. If the subject is receiving RAAS inhibitors the dose must have been stable for greater than one month prior to the Screening Period.
- •6. If the subject is receiving RAAS inhibitors the dose must have been stable for at
- •least one month prior to the Screening Period. However, subject may have
- •switched to different brands but at equivalent doses as determined by the study
- •physician during the three months 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
- •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:
- •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
- •Subjects must not meet any of the following criteria:
- •1. Subject has previously been on prescription-based vitamin D therapy within the
- •four weeks prior to the Screening Period.
- •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. Pregnant (confirmed by screening pregnancy test) or lactating females.
- •4. Subject is expected to initiate renal replacement therapy within one year.
- •5. Subject is expected to receive an increased dose of RAAS inhibitor (ACEi,
- •ARB or aldosterone inhibitor) during the course of the study.
- •6. 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.
- •7. 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.
- •8. Subject has asymmetric septal hypertrophy defined as septal wall
- •thickness/posterior wall thickness ratio > 1.5 based on screening echocardiogram.
- •9. Subject has had a severe cerebrovascular accident (CVA) within last 3 months
- •(e.g. hemorrhagic) prior to screening.
- •10. 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.
- •11. Subject has co-morbid conditions (e.g. advanced malignancy, advanced liver
- •disease) with a life expectancy less than 1 year.
- •12. Subject has received any investigational drug within 30 days prior to study drug
- •administration or is currently enrolled in another clinical trial.
- •13. Subject has a history of kidney stones within 2 years prior to the Screening period.
- •14. Subject has poorly controlled hypertension (systolic blood pressure > 180 mmHg
- •and/or diastolic blood pressure > 110 mmHg at the Screening Visit (confirmed by
- •15. Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma).
- •16. 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.
- •17. Subject is currently receiving immunosuppressant therapy and/or high doses
- •(non-maintenance therapy) of glucocorticoids (> 5 mg/day of prednisone or equivalent).
- •18. Subject has had acute renal failure within 12 weeks of the Screening Phase defined by an acute rise in serum Cr (of at least 0.5 mg/dL or 44 micromoles/L) to more than 4 g/dL (350 micromoles/L).
- •19. Subject is known to be HIV positive.
- •20. 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.
- •21. Subject is contraindicated for the MRI examination (i.e., pacemaker).
- •22. For any reason, subject is considered by the Investigator to be an unsuitable
- •candidate to receive paricalcitol capsul
Investigators
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