A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 主要终点
- Mean Erythropoietin Dose Per Visit
研究概览
简要总结
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •A subject will only be included if all the following entry criteria are met:
- •Patients ≥ 18 years of age
- •Stage 5 chronic kidney disease (CKD) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT)
- •Patients with anemia due to renal insufficiency but who are iron replete:; Transferrin saturation (TSAT) > 20% and Ferritin levels > 200 ng/mL and requiring treatment with erythropoietin (EPO)
- •Patients with vitamin B levels > lower limit of normal (LLN) and folic acid levels > LLN
- •Patients treated only with intravenous calcitriol for at least 6 months
- •Patients with serum intact parathyroid hormone (iPTH) level > 500 pg/mL
- •Patients with calcium phosphate product (Ca × PO4) < 65 mg²/dL²
- •Patients willing to sign "written informed consents" before participating in any the study related activity.
- •Patients with phosphorus levels < 6.5 mg/dL and calcium levels < 11.2 mg/dL
排除标准
- •A subject will be excluded from the study if he/she meets any of the following criteria:
- •Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
- •Patients who have participated in a clinical study within the last month.
- •Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
- •Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the Summary of Product Characteristics (SmPC).
- •Pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
- •Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
- •Patients with microcytic (mean corpuscular volume [MCV] < 80 fL) and macrocytic (MCV > 100 fL) anemia at screening that may be caused by diseases such as for microcytic anemias - Iron Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zinc poisoning, Sideroblastic Anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.
研究组 & 干预措施
Paricalcitol
Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia.
干预措施: Paricalcitol (Drug)
Paricalcitol
Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL.
Participants may have also received routine darbepoetin alfa to treat anemia.
干预措施: Darbepoetin alfa (Drug)
结局指标
主要结局
Mean Erythropoietin Dose Per Visit
时间窗: Baseline and Months 1, 2, 3, 4, 5 and 6
The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.
次要结局
- Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6(Baseline and Month 6)
- Number of Participants With Adverse Events(From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.)
- Mean Calcium Level at Baseline and Month 6(Baseline and Month 6)
- Vitamin B12 Levels(Baseline and month 6)
- Mean Alkaline Phosphatase Level at Baseline and Month 6(Baseline and Month 6)
- Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire(Baseline and Month 6)
- Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6(Baseline and Month 6)
- Mean Phosphorus Level at Baseline and Month 6(Baseline and Month 6)
- Folic Acid Levels(Baseline and month 6)
- Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6(Baseline and Month 6)