跳至主要内容
临床试验/NCT01051323
NCT01051323已完成不适用

Non-interventional Study to Investigate Hemoglobin Levels and Dose Over Time in the Daily Use of Mircera for Renal Anemia in Larger Centers, and to Detect Differences Between Standard of Care in the Centers

Hoffmann-La Roche0 个研究点目标入组 1,580 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
1,580
主要终点
Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size

研究概览

简要总结

This observational study will investigate hemoglobin levels and Mircera (methoxy polyethyleneglycol-epoetin beta) dose over time in patients with chronic kidney disease, and compare standards of care between centers. Data from each patient will be collected over 12 months of Mircera therapy.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • adult patients, >/= 18 years of age
  • chronic kidney disease
  • informed consent for data transmission

排除标准

  • serious hematological or infectious disease
  • acute bleeding in the 16 weeks preceding data collection
  • participation in an interventional trial
  • female patients: pregnancy or breast-feeding

研究组 & 干预措施

1

干预措施: methoxy polyethylene glycol-ep [Mircera] (Drug)

结局指标

主要结局

Maximum Intra-Individual Fluctuation of Hemoglobin Values by Predialysis/Hemodialysis, Age, and Center Size

时间窗: Month 0 to Month 12

For characterization of intra-individual fluctuations, the maximum absolute differences were derived from study period specific individual mean values. Maximum intra-individual fluctuation of hemoglobin values by predialysis/hemodialysis, age (\<65 years, \>=65 years), and center size (\>100 participants, \<=100 participants) is presented. Data for this outcome measure was reported for overall participants.

Serum Ferritin Values

时间窗: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Serum ferritin levels were measured as nanogram/milliliter (ng/mL). Data for this outcome measure was reported for overall participants.

Serum Iron Values

时间窗: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Serum iron levels were measured as microgram/deciliter (mcg/dL). Data for this outcome measure was reported for overall participants.

Number of Participants Who Switched to Other Erythropoiesis Stimulating Agents (ESA)-Therapy

时间窗: Month 12 or early discontinuation

Number of participants who switched to other ESA therapies including Aranesp, Biopoin, Biosimilar, Erypo, and NeoRecormon is presented. Data for this outcome measure was reported for overall participants.

Percentage of Participants With at Least One Hemoglobin Value Outside the Target Range

时间窗: Month 0 to Month 12

Mean hemoglobin was calculated from measurements taken during the Evaluation Period (Month 0 to Month 12). The target hemoglobin range was 10 to 13 gram/deciliter (g/dL). Percentage of participants with at least one hemoglobin value less than (\<) 10 g/dL or greater than (\>) 13 g/dL during the evaluation period by predialysis/hemodialysis is presented.

Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Evaluation Period by Dose Modification, Age, and Center Size

时间窗: Month 0 to Month 12

The percentage of participants with hemoglobin (Hb) values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during evaluation period (Month 0 to Month 12) by dose modification (yes or no), age (\<65 years, greater than or equal to \[\>=\] 65 years) and center size (\>100 participants, less than or equal to \[\<=\] 100 participants) is presented.

Percentage of Participants With Hemoglobin Values Within Pre-defined Ranges During Month 6 to Month 12 by Dose Modification, Age, and Center Size

时间窗: Month 6 to Month 12

The percentage of participants with hemoglobin values within the pre-defined ranges (10-12 g/dL, 11-12 g/dL, and 11-13 g/dL) during Month 6 to Month 12 by dose modification (yes or no), age (\<65 years, \>=65 years) and center size (\>100 participants, \<=100 participants) is presented.

Transferrin Values

时间窗: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Transferrin levels were measured as milligram/deciliter (mg/dL). Data for this outcome measure was reported for overall participants.

Transferrin Saturation Values

时间窗: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

Transferrin saturation (TSAT) measured as a percentage, is a medical laboratory test. It is the ratio of serum iron and total iron-binding capacity, multiplied by 100. Data for this outcome measure was reported for overall participants.

C-reactive Protein (CRP) Values

时间窗: Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12

The test for CRP is a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultrasensitive assay. A decrease in the level of CRP indicates reduction in inflammation and therefore improvement. Data for this outcome measure was reported for overall participants.

Number of Participants With Reasons for Discontinuation of Methoxy Polyethyleneglycol-epoetin Beta Treatment After Study Completion

时间窗: Month 12 or early discontinuation

At final visit, physicians were asked to state the reasons in case of discontinuation of treatment with methoxy polyethyleneglycol-epoetin beta. The same participant could have discontinued treatment due to multiple reasons. Data for this outcome measure was reported for overall participants.

Number of Participants Satisfied With Treatment at Final Visit

时间窗: Month 12 or early discontinuation

Participants were asked to rate their satisfaction with methoxy polyethyleneglycol-epoetin beta treatment at final visit. Participants' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". Data for this outcome measure was reported for overall participants.

Number of Physicians Satisfied With Treatment at Final Visit

时间窗: Month 12 or early discontinuation

Physicians were asked to rate their satisfaction with the methoxy polyethyleneglycol-epoetin beta treatment at final visit. Physicians' responses were "very satisfied", "satisfied", "undecided", or "not satisfied". One physician could analyze multiple participants but for the purpose of analysis each physician was counted as one for each analyzed participants; hence, the number of physicians (as per this assessment) was equal to the number of participants analyzed. Data for this outcome measure was reported for overall participants.

Number of Participants Who Continued Treatment With Methoxy Polyethyleneglycol-epoetin Beta After Study Completion

时间窗: Month 12 or early discontinuation

At final visit, physicians were asked to answer ("yes" or "no") the question, whether they would continue treatment with methoxy polyethyleneglycol-epoetin beta treatment after study completion. Data for this outcome measure was reported for overall participants.

次要结局

  • Average Methoxy Polyethylene Glycol-epoetin Beta Dose(Months 0, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, and 12)

研究者

申办方类型
Industry
责任方
Sponsor

相似试验