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Clinical Trials/EUCTR2007-001689-34-SE
EUCTR2007-001689-34-SEActive, not recruitingNot Applicable

The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4 - PRIMO I

Abbott GmbH & Co. KG0 sites220 target enrollmentStarted: May 6, 2009Last 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

  • •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 = 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/1.73 m2 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.
  • •? 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. Subject must have a technically adequate baseline cardiac MRI.
  • •7. 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 active vitamin D therapy (calcitriol, paricalcitol,
  • •doxercalciferol, alfacalcidol) 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 active kidney stones within the 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.
  • +5 more not shown

Investigators

Similar Trials

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Not Applicable
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
EUCTR2007-001689-34-DEAbbott GmbH & Co. KG220
Active, not recruiting
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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
EUCTR2007-001689-34-CZAbbott GmbH & Co. KG220
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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 I
EUCTR2007-001689-34-GBAbbott GmbH & Co. KG220
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The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4.Estudio Primo: Beneficios de Paricalcitol cápsulas sobre la morbilidad cardíaca provocada por la insuficiencia renal en los sujetos con enfermedad renal crónica en estadios 3B/4. - PRIMO I
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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-CZAbbott GmbH & Co. KG220