The PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5.Estudio Primo II : Beneficios de Paricalcitol inyectable sobre la morbilidad cardíaca provocada por la insuficiencia renal en los sujetos con enfermedad renal crónica en estadio 5. - PRIMO II

• Conditions: Stage 5 Chronic Kidney Disease (CKD) in subjects receiving hemodialysis who haveleft ventricular hypertrophy (LVH).Enfermedad renal crónica (ERC) en estadio 5 en sujetos que están recibiendo hemodiálisis con hipertrofia ventricular izquierda.; MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney disease; MedDRA version: 9.1Level: LLTClassification code 10049773Term: Left ventricular hypertrophy

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-12
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

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

Inclusion Criteria

To be eligible for participation, 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 between 18 and 80 years.
3. Stage 5 CKD receiving chronic hemodialysis three times per week for = 3 months
and = 12 months from date of Screening Visit.
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
12-15 mm; and,
? For males, LV ejection fraction = 50% and septal wall thickness between
13-16 mm.
6. In the opinion of the investigator, the subject must be receiving optimal medical
management of left ventricular hypertrophy and CKD including appropriate use of
RAAS inhibitor (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 at
least three months 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
serum urine 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 (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

To be eligible for participation, subjects must not meet any of the following criteria:
1. Subject has previously been on prescription-based vitamin D therapy within the
three months 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. Subject is expected to receive a new or 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 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 a history of kidney stones.
12. Subject has poorly controlled hypertension (systolic blood pressure > 180 mmHg
and/or diastolic blood pressure > 110 mmHg) at the Screening Visit (confirmed by
repeat).
13. Subject has secondary hypertension (i.e., renal artery stenosis, primary
aldosteronism or pheochromocytoma).
14. Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except
topical or inhaled glucocorticoids), or other drugs that may affect calcium or bone
metabolism, other than calcium containing phosphate binders or female subjects
on stable (same dose and product for three months) estrogen and/or progestin
therapy.
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.

Study & Design

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