EUCTR2007-001689-34-GB
Active, not recruiting
Not Applicable
The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3/4 - PRIMO I
DrugsZemplar
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- 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
- •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
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.
Outcomes
Primary Outcomes
Not specified
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