The PRIMO Study: Paricalcitol Capsules Benefits Renal Failure Induced Cardiac Morbidity in Subjects With Chronic Kidney Disease Stage 3/4
Condition: Chronic Kidney Disease; Left Ventricular Hypertrophy
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Hypertrophy, Left Ventricular; Hypertrophy
Intervention: paricalcitol; placebo
Intervention description: 2 µg capsule; placebo capsule
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 227.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: paricalcitol; Zemplar; PRIMO; Chronic Kidney Disease Stage 3B/4

Summary:

      To evaluate the effects of paricalcitol capsules on cardiac structure and function over 48
      weeks in patients with Stage 3/4 chronic kidney disease (CKD) who had left ventricular
      hypertrophy (LVH).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Estimated glomerular filtration rate (GFR) between 15-60 mL/min/1.73 m^2

          -  Serum intact parathyroid hormone (iPTH) value between 50-300 pg/mL

          -  Corrected serum calcium level 8.0-10.0 mg/dL (2.0-2.5 mmol/L)

          -  Phosphorous level less than or equal to 5.2 mg/dL (1.68 mmol/L)

          -  Serum albumin greater than or equal to 3.0 g/dL (30 g/L)

          -  Echocardiogram results of:

               -  Females: Left ventricular (LV) ejection fraction greater than or equal to 50% and
                  septal wall thickness between 11-17 mm; and,

               -  Males: LV ejection fraction greater than or equal to 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.
             However, the subject may have switched to different brands but at equivalent doses as
             determined by the study physician during the month prior to the Screening Period.

          -  Subject must have a technically adequate baseline cardiac magnetic resonance imaging
             (MRI).

        Exclusion Criteria:

          -  Subject has previously been on active vitamin D therapy within the four weeks prior to
             the Screening Period

          -  Pregnant or lactating females

          -  Subject is expected to initiate renal replacement therapy within one year

          -  Subject is taking calcitonin, bisphosphonates, cinacalcet, glucocorticoids (except
             topical or inhaled glucocorticoids)

          -  Subject had clinically significant coronary artery disease (CAD) within 3 months prior
             to the Screening Period, defined as either hospitalization for myocardial infarction
             (MI) or unstable angina; new onset angina with positive functional study or coronary
             angiogram revealing stenosis; or coronary revascularization procedure.

          -  Subject had major cardiac valve abnormality linked with LVH and/or diastolic
             dysfunction, defined as either aortic valve area ≤ 1.5 cm^2 or a mean gradient of > 20
             mmHg; or regurgitation lesions; more than moderate mitral regurgitation, or more than
             moderate aortic regurgitation.

          -  Subject had asymmetric septal hypertrophy defined as septal wall thickness/posterior
             wall thickness ratio > 1.5 based on screening echocardiogram.

          -  Subject had a severe cerebrovascular accident (CVA) within the last 3 months (e.g.,
             hemorrhagic) prior to screening.

          -  Subject had full remission from a malignancy for less than 1 year except completely
             excised non-melanoma skin cancer (e.g., basal or squamous carcinoma) or any history of
             bone metastasis.

          -  Subject had comorbid conditions (e.g., advanced malignancy, advanced liver disease)
             with a life expectancy less than 1 year.