Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.
Anemia of inflammation and secondary hyperparathyroidism (SHPT) are two common clinical complications in patients with chronic kidney disease. Eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process. The use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the AI. If the use of the paricalcitol for the SHPT control may exert direct influence on the erythropoiesis process is not known.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
19
Paricalcitol 2 capsules/three times per week
epoetin 1-3 times per week
Placebo 2 capsules/three times per week
Son Espases University Hospital
Palma de Mallorca, Balearic Islands, Spain
Changes in ESA dosage
Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.
Time frame: 6 months
Changes on ferrokinetics.
Changes on serum iron, transferrin, ferritin, transferrin saturation and red cell distribution width at month 6.
Time frame: 6 months
Changes on interleukin-6 plasma levels.
Changes on pg/ml
Time frame: 6 months
Changes on hepcidin plasma levels.
Changes on pg/ml
Time frame: 6 months
Changes on erythropoietin plasma levels.
Changes on mUI/ml
Time frame: 6 months
Changes on systolic blood pressure.
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
Time frame: 6 months
Changes on diastolic blood pressure.
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
Time frame: 6 months
Cardiovascular serious adverse events in each arm of treatment.
Cardiac arrest, angina pectoris. Stroke.
Time frame: 6 months
Adverse events related to vascular access disfunction.
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Arteriovenous fistula site hemorrhage or thrombosis. Catheter disfunction.
Time frame: 6 month