JPRN-jRCTs051210090已完成未知
A study on the change in hemoglobin levels after switching from ESA to vadadustat in hemodialysis patients
Tsuruya Kazuhiko0 个研究点目标入组 47 人开始时间: 2021年9月22日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 47
研究概览
简要总结
A total of 47 hemodialysis patients were enrolled, and 37 patients who were switched from ESA to VAD were analyzed based on predefined conditions. Hb level at 4 wk was not significantly lower than that at BL. Hb levels from 6 to 16wk were slightly below the BL value, but the decrease was not as large as that observed in the clinical trial. We could not conclude that the aggressive dose adjustment prevented Hb levels from early declining because of unscheduled dose adjustments were performe in 19 patients.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Aged 20 years or older at the time of obtaining consent (irrespective of sex)
- •2. Diagnosis of CKD based on evidence-based clinical practice guidelines for CKD 2018 (edited by the Japanese Society of Nephrology) by the time of obtaining consent
- •3. Receiving hemodialysis or hemodiafiltration 3 times a week for more than 12 weeks prior to the time of obtaining consent, excluding receiving home dialysis or combination of peritoneal dialysis
- •4. Receiving the same ESA by the same route, at the same intervals, and at the prescribed dose within 8 weeks prior to the time of obtaining consent
- •5. Mean of the two screening Hb levels closest in the time of obtaining consent (average of the latest 2 times) is 9.5 g/dL or higher and <12.0 g/dL
- •6. Fluctuation between the two Hb levels closest in the time of obtaining consent during the screening period less than 1.5 g/dL
- •7. Serum ferritin level of 100ng/mL or higher and transferrin saturation level (TSAT) of 20% or higher before the time of obtaining consent (If the serum ferritin level is less than 100ng/mL or the TSAT is less than 20%, these parameters are measured again. The patients can enter the study after confirmation of serum ferritin level is 100 ng/mL or more and the TSAT is 20% or more.)
排除标准
- •1. Anemia due to a main cause other than CKD (sickle cell disease, myelodysplastic syndrome, bone marrow fibrosis, hematologic malignancy, hemolytic anemia, thalassemia, or pure red cell aplasia) after the time of obtaining consent
- •2. Active bleeding or recent blood loss within 8 weeks prior to the time of obtaining consent
- •3. RBC transfusion within 8 weeks prior to the time of obtaining consent
- •4. Received testosterone enanthate or mepitiostane within 8 weeks prior to the time of obtaining consent
- •5. Patients who are judged by the principal investigator (or sub-investigators) to require treatment such as salvage treatment or withdrawal of the investigated drug after the start of the investigated drug
- •6. Patients who are expected to eliminate the need for hemodialysis or hemodiafiltration due to recovery of renal function
- •7. AST (standard value: 10 to 40 U/L), ALT (standard value: 5 to 45 U/L), or total bilirubin (standard value: 0.2 to 1.2 mg/dL) before the time of obtaining consent >2.5 x upper limit of normal; does not apply to patients with Gilbert's syndrome
- •8. Uncontrolled hypertension (systolic blood pressure >180 mmHg or diastolic blood pressure >110 mmHg)
- •9. Severe heart failure (New York Heart Association Class IV)
- •10. Cerebrovascular disorder or acute coronary syndrome (hospitalization due to unstable angina or myocardial infarction), requiring hospitalization due to urgent percutaneous coronary intervention or heart failure within 12 weeks prior to the time of obtaining consent
- •11. Current or past history of malignancy. History of malignancy with no recurrence for the recent 5 years (or no recurrence for the recent 5 years after the last administration of anticancer drugs) is not an exclusion criterion
- •12. New onset or recurrent event of deep vein thrombosis or pulmonary embolism within 12 weeks prior to the time of obtaining consent
- •13. Current or history of hemosiderosis or hemochromatosis
- •14. History of prior organ transplantation or scheduled organ transplant, or prior transplantation of hematopoietic stem cell or bone marrow; does not apply to patients scheduled to be enrolled in the kidney transplant waiting list
- •15. Patients participating in interventional trials (including clinical trials) other than this study
- •16. Patient with intolerable for HIF-PH inhibitors
- •17. Female patients who are pregnant or breast feeding, or are predicted to be pregnant
- •18. Patients whose folic acid and vitamin B12 are deviated from the minimum value( folic acid:3.6ng/mL and vitamin B12:233pg/mL)
- •19. Patients who are judged by the doctors to be ineligible for complications or medical history such as cerebral infarction, myocardial infarction, or pulmonary embolism
- •20. Patients who are judged by the principal investigator (or sub-investigators) to be inappropriate as subjects in this study
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