Paricalcitol Improves Anemia of Inflammation

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Son Espases
• Treatments: Epoetin Alfa; Ergocalciferols; Hematinics; Vitamin D; Vitamins

Criteria

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 variationprior 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

• 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

• 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.