Paricalcitol Improves Anemia of Inflammation

STATUS

Recruiting
End date

Dec 13, 2023
participants needed

46
sponsor

Hospital Son Espases

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Updated on 13 March 2021

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iron

calcium

anemia

vitamin d

erythropoietin

vitamins

epoetin beta

transferrin

transferrin saturation

Summary

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.

Description

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.

Details

Condition	Blood disorder, Hematological Disorders, Anemia, Anemia, Anemia; Non-Hodgkin’s Lymphoma, Anemia; Non-Hodgkin’s Lymphoma, Hematological Disorders, anaemia
Treatment	Placebo, epoetin beta, Paricalcitol
Clinical Study Identifier	NCT02876211
Sponsor	Hospital Son Espases
Last Modified on	13 March 2021

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	Age >= 18 years
	Patients with CKD on hemodialysis of any etiology
	Hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study
	Hemoglobin plasma levels stabilized: Hb variation <or = 1 g / dl for the two months prior to inclusion in the study
	Patients with anemia of renal etiology
	ESA treatment with stable doses for 2 months prior to baseline.Stable dose ESA Definition: Variation <or = 3000UI/week
	Iron status: Ferritin> 200 ng / mL and/or transferrin saturation index (IST):> = 20%)
	KT / V >= 1.2 ( Daugirdas-2nd generation)
	Calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl
	Vitamin D 25OH normal >= 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 IU / bi-weekly for 6 weeks in selected patients)
	PTHi concentrations> = 150 pg / mL and <or = to 300 pg / ml
	Patients who accept their inclusion in the study and sign informed consent
Exclusion Criteria
	Epoetin beta dose > 18,000 IU / weekly
	Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the Ogino-Knaus contraceptive method is considered unsuitable)
	Active bleeding episode or history of transfusion the 2 months prior to baseline
	Patients with non-renal causes of anemia: malignancies, folic acid or vitamin B12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin
	Patients treated with the selective vitamin D receptor activator in the 3 months prior to inclusion in the study
	Acute or chronic symptomatic: heart failure (IV-NYHA), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia
	Immunosuppressive treatment with uncontrolled Hemoglobin level
	Allergy to paricalcitol or any of its components

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Paricalcitol Improves Anemia of Inflammation