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Clinical Trials/NCT00616902
NCT00616902TerminatedPhase 3

Clinical Study Protocol M10-221 The PRIMO II Study: Paricalcitol Injection Benefits in Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease (CKD) Stage 5

Abbott64 sites in 8 countries12 target enrollmentStarted: January 2009Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Terminated
Sponsor
Abbott
Enrollment
12
Locations
64
Primary Endpoint
Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

To evaluate the effects of paricalcitol injection on cardiac structure and function over 48 weeks in subjects with Stage 5 Chronic Kidney Disease (CKD) receiving hemodialysis who have left ventricular hypertrophy (LVH).

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Stage 5 CKD receiving chronic hemodialysis three times per week for >= 3 months and <= 12 months from date of Randomization (Day 1).
  • •Serum intact parathyroid hormone (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).
  • •Echocardiogram results:
  • •For females, left ventricular (LV) ejection fraction >= 50% and septal wall thickness between 11-17 mm.
  • •For males, LV ejection fraction >= 50% and septal wall thickness between 12-18 mm.
  • •If the subject is receiving Renin Angiotensin-Aldosterone System (RAAS) inhibitors, the dose must have been stable for greater than one month prior to the Screening Period.
  • •A technically adequate baseline cardiac magnetic resonance imaging (MRI).
  • •If female, subject is not breast feeding or is not pregnant, or is not of childbearing potential, defined as postmenopausal for at least one year or surgically sterile, or is of childbearing potential and practicing one of the following methods of birth control:
  • •Double-barrier method
  • •Hormonal contraceptives 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.

Exclusion Criteria

  • •Subject has previously been on active vitamin D therapy (calcitriol, paricalcitol, doxercalciferol, alfacalcidol) for a total duration greater than three months since the start of dialysis.
  • •Subject has a history of an allergic reaction or significant sensitivity to paricalcitol or to drugs similar to the study drug.
  • •Subject is expected to receive an increased dose of RAAS inhibitor (Angiotensin converting enzyme inhibitor [ACEi], Angiotensin II receptor blocker [ARB] or aldosterone inhibitor) during the course of the study.
  • •Subject has clinically significant coronary artery disease (CAD) within 3 months prior to the Screening Period, defined as one of the following:
  • •Hospitalization for myocardial infarction (MI) or unstable angina; or
  • •New onset angina with positive functional study or coronary angiogram revealing stenosis; or
  • •Coronary revascularization procedure.
  • •Subject has major cardiac valve abnormality linked with left ventricular hypertrophy (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.
  • •Subject has asymmetric septal hypertrophy.
  • •Subject has had a severe cerebrovascular accident (CVA) within the last three months (e.g., hemorrhagic) prior to screening.
  • •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.
  • •Subject has co-morbid conditions.
  • •Subject has received any investigational drug within 30 days prior to study drug administration or is currently enrolled in another clinical trial.
  • •Subject has poorly controlled hypertension.
  • •Subject has history of renal artery stenosis, primary aldosteronism or pheochromocytoma
  • •Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except topical or inhaled glucocorticoids)
  • •Subject is currently receiving immunosuppressant therapy and/or high doses of glucocorticoids
  • •Subject is known to be HIV positive.
  • •Use of known inhibitors or inducers of cytochrome P450 3A (CYP3A) within two weeks prior to study drug administration
  • •Subject is contraindicated for the MRI examination
  • •Investigator considers subject unsuitable for any reason
  • •Subject has a history of drug or alcohol abuse within six months prior to screening
  • •Subject weighs more than 340 pounds (154 kg)
  • •Subject has had a liver transplant

Arms & Interventions

Paricalcitol Injection 4 mcg/mL

Active Comparator

Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis

Intervention: paricalcitol injection 4 mcg/mL (Drug)

Placebo Injection 4 mcg/mL

Placebo Comparator

Placebo Injection 4 mcg/mL given intravenously three times a week during dialysis

Intervention: Placebo Injection 4 mcg/mL (Drug)

Outcomes

Primary Outcomes

Change From Baseline in Left Ventricular Mass Index (LVMI) Over 48 Weeks Measured by Cardiac Magnetic Resonance Imaging (MRI)

Time Frame: Baseline, 24 Weeks, and 48 Weeks/Early Termination

Change from Baseline in left ventricular mass index (LVMI) over 48 weeks measured by cardiac MRI. The effects of paricalcitol injection on progression or regression of left ventricular hypertrophy (LVH) in participants with Stage 5 chronic kidney disease (CKD) on hemodialysis (HD) compared to placebo. Left Ventricular Mass is normalized to the participant's height by the following equation to obtain LVMI: LVM (g) divided by height (m)2.7. The primary comparison was between the 4 mcg paricalcitol injection and the placebo treatment groups in the change from baseline to Week 48.

Secondary Outcomes

  • Change From Baseline in the Echocardiographic Assessment of Diastolic Function Assessed by Evaluating Changes in Diastolic Mitral Annular Relaxation Velocity (E') Over 48 Weeks.(Baseline, 24 Weeks, and 48 Weeks/Early Termination)
  • Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Isovolumetric Relaxation Time (IVRT) Over 48 Weeks.(Baseline, 24 Weeks, and 48 Weeks/Early Termination)
  • Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function of Peak E-wave Velocity to Lateral E-wave Velocity (E/E') Over 48 Weeks.(Baseline, Week 24, and Week 48/Early Termination)
  • Change From Baseline in Evaluating Changes in the Additional Measure of Diastolic Function E-wave Deceleration Time (DT) Over 48 Weeks(Baseline, 24 Weeks, and 48 Weeks/Early Termination)
  • Change From Baseline in Biological Marker Triiodothyronine (T3).(Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks))
  • Change From Baseline in Biological Marker Plasma Troponin-T Over 48 Weeks(Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks))
  • Change From Baseline in Biological Marker Plasma Interleukin-6 (IL-6) Over 48 Weeks(Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks))
  • Change From Baseline in Biological Marker Plasma High Sensitivity C-reactive Protein (hsCRP) Over 48 Weeks(Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks))
  • Change From Baseline in Biological Marker Plasma B-Type Natriuretic Peptide (BNP)(Baseline and Early Termination Visit (4 Weeks, 5 Weeks, 7 Weeks, 8 Weeks, 14 Weeks, and 16 Weeks))

Investigators

Sponsor
Abbott
Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (64)

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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