Paricalcitol Improves Anemia of Inflammation

  • STATUS
    Recruiting
  • End date
    Dec 13, 2023
  • participants needed
    46
  • sponsor
    Hospital Son Espases
Updated on 13 March 2021
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 IdentifierNCT02876211
SponsorHospital Son Espases
Last Modified on13 March 2021

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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