EUCTR2007-001689-34-SE
Active, not recruiting
Not Applicable
The PRIMO Study: Paricalcitol Capsules benefits in Renal failure Induced cardiac Morbidity in Subjects with Chronic Kidney Disease Stage 3B/4 - PRIMO I
ConditionsStage 3B/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
DrugsZemplar
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Stage 3B/4 chronic kidney disease (CKD) in subjects who have left 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
- •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
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.
Outcomes
Primary Outcomes
Not specified
Similar Trials
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 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 hypertrophyEUCTR2007-001689-34-DEAbbott GmbH & Co. KG220
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 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 hypertrophyEUCTR2007-001689-34-CZAbbott GmbH & Co. KG220
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 IEUCTR2007-001689-34-GBAbbott GmbH & Co. KG220
Active, not recruiting
Not Applicable
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 IEUCTR2007-001689-34-ESAbbott GmbH & Co. KG220
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 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 hypertrophyEUCTR2007-005092-33-CZAbbott GmbH & Co. KG220