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Clinical Trials/EUCTR2007-005092-33-CZ
EUCTR2007-005092-33-CZActive, not recruitingNot Applicable

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

Abbott GmbH & Co. KG0 sites220 target enrollmentStarted: February 26, 2008Last updated:
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Conditions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
220
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional clinical trial of medicinal product

Eligibility Criteria

Sex
All

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
  • •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
  • •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
  • •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.

Investigators

Similar Trials

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The PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5 - PRIMO IIStage 5 Chronic Kidney Disease (CKD) in subjects receiving hemodialysis who haveleft ventricular hypertrophy (LVH).MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseMedDRA version: 9.1Level: LLTClassification code 10049773Term: Left ventricular hypertrophy
EUCTR2007-005092-33-GBAbbott GmbH & Co. KG220
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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
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The PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5 - PRIMO IIStage 5 Chronic Kidney Disease (CKD) in subjects receiving hemodialysis who haveleft ventricular hypertrophy (LVH).MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseMedDRA version: 9.1Level: LLTClassification code 10049773Term: Left ventricular hypertrophy
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The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3/4 - PRIMO IStage 3/4 chronic kidney disease (CKD) in subjects who have left ventricular hypertrophy (LVH).MedDRA version: 9.1Level: LLTClassification code 10064848Term: Chronic kidney diseaseMedDRA version: 9.1Level: LLTClassification code 10049773Term: Left ventricular hypertrophy
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