Benefits of the Paricalcitol (Selective Vitamin D Receptor Activator) on Anemia of Inflammation in Dialysis Patients Under Erythropoiesis-stimulating Agents Treatment.
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Changes in ESA dosage
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
paricalcitol plus epoetin beta
Paricalcitol 2 capsules /three times per week & epoetin
干预措施: Paricalcitol (Drug)
paricalcitol plus epoetin beta
Paricalcitol 2 capsules /three times per week & epoetin
干预措施: Epoetin beta (Drug)
placebo plus epoetin beta
Placebo 2 capsules/three times per week & epoetin
干预措施: Epoetin beta (Drug)
placebo plus epoetin beta
Placebo 2 capsules/three times per week & epoetin
干预措施: Placebo (Drug)
结局指标
主要结局
Changes in ESA dosage
时间窗: 6 months
Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.
次要结局
- Cardiovascular serious adverse events in each arm of treatment.(6 months)
- Adverse events related to vascular access disfunction.(6 month)
- Changes on ferrokinetics.(6 months)
- Changes on interleukin-6 plasma levels.(6 months)
- Changes on hepcidin plasma levels.(6 months)
- Changes on erythropoietin plasma levels.(6 months)
- Changes on systolic blood pressure.(6 months)
- Changes on diastolic blood pressure.(6 months)
研究者
Miguel Giovanni Uriol Rivera
Ph.D. MD.
Hospital Son Espases