EUCTR2007-005092-33-GB
Active, not recruiting
Not Applicable
The PRIMO II Study: Paricalcitol Injection benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 5 - PRIMO II
ConditionsStage 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
DrugsZemplar
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage 5 Chronic Kidney Disease (CKD) in subjects receiving hemodialysis who haveleft ventricular hypertrophy (LVH).
- Sponsor
- Abbott GmbH & Co. KG
- Enrollment
- 220
- Status
- Active, not recruiting
- Last Updated
- 12 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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 greater than 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
Exclusion Criteria
- •To be eligible for participation, subjects must not meet any of the following criteria:
- •1\. Subject has been on active vitamin D therapy (e.g., calcitriol, parocalcitiol, doxercalciferol, alfacalcidol) within the previous 4 weeks prior to the Screening Period and/or 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
Outcomes
Primary Outcomes
Not specified
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