Paricalcitol Improves Anemia of Inflammation
Palabras clave
Abstracto
Descripción
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.
fechas
| Verificado por última vez: | 12/31/2019 |
| Primero enviado: | 08/11/2016 |
| Inscripción estimada enviada: | 08/16/2016 |
| Publicado por primera vez: | 08/22/2016 |
| Última actualización enviada: | 01/08/2020 |
| Última actualización publicada: | 01/12/2020 |
| Fecha de inicio real del estudio: | 11/30/2014 |
| Fecha estimada de finalización primaria: | 06/30/2021 |
| Fecha estimada de finalización del estudio: | 11/30/2022 |
Condición o enfermedad
Intervención / tratamiento
Drug: paricalcitol plus epoetin beta
Drug: Epoetin beta
Drug: placebo plus epoetin beta
Fase
Grupos de brazos
| Brazo | Intervención / tratamiento |
|---|---|
| Experimental: paricalcitol plus epoetin beta Paricalcitol 2 capsules /three times per week & epoetin | Drug: paricalcitol plus epoetin beta Paricalcitol 2 capsules/three times per week |
| Placebo Comparator: placebo plus epoetin beta Placebo 2 capsules/three times per week & epoetin | Drug: placebo plus epoetin beta Placebo 2 capsules/three times per week |
Criterio de elegibilidad
| Edades elegibles para estudiar | 18 Years A 18 Years |
| Sexos elegibles para estudiar | All |
| Acepta voluntarios saludables | si |
| Criterios | 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 - 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. |
Salir
Medidas de resultado primarias
1. Changes in ESA dosage [6 months]
Medidas de resultado secundarias
1. Changes on ferrokinetics. [6 months]
2. Changes on interleukin-6 plasma levels. [6 months]
3. Changes on hepcidin plasma levels. [6 months]
4. Changes on erythropoietin plasma levels. [6 months]
5. Changes on systolic blood pressure. [6 months]
6. Changes on diastolic blood pressure. [6 months]
7. Cardiovascular serious adverse events in each arm of treatment. [6 months]
8. Adverse events related to vascular access disfunction. [6 month]
