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An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia

2017年6月13日更新者：Hoffmann-La Roche

Efficacy of C.E.R.A. for Correction of Anemia and Maintenance of the Hb Levels in CKD Patients on Dialysis , Treated According to Routine Clinical Practice

This observational study will evaluate the use in clinical practice and efficacy of Mircera (methoxy polyethylene glycol-epoetin beta) in chronic kidney disease patients on dialysis receiving Mircera for the treatment of chronic renal anemia. Eligible patients will be followed for 24 weeks.

調査の概要

状態

完了

条件

貧血

研究の種類

観察的

入学 (実際)

127

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

インド
- - Ahmedabad、インド、380005
    - Ahmedabad Dialysis Centre
  - Guwahati、インド、781007
    - Excel Center
  - Kolkata、インド、600054
    - ESIS Hospital; Department of Nephrology
  - Mumbai、インド、400083
    - Vertex Hospital
  - New Delhi、インド、110076
    - Apollo Indraprastha Hospitals; Nephrology
  - Pune、インド、411033
    - Aditya Birla Memorial Hospital
- Delhi
  - New Delhi、Delhi、インド、110060
    - Sir Gangaram Hospital

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

確率サンプル

調査対象母集団

Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia

説明

Inclusion Criteria:

Adult patients, 18 to 65 years of age, inclusive
Patients with chronic kidney disease on dialysis
ESA naïve with Hb < 10 g/dL, or on treatment with ESAs other than Mircera and Hb within the target range of 10-12 g/dL
Adequate irons status as judged by the treating physician

Exclusion Criteria:

Hypersensitivity to recombinant human erythropoietin, polyethylene glycol or to any constituent of the study medication
Clinically significant concomitant disease or disorder as defined by protocol
Clinical suspicion of pure red cell aplasia (PRCA)
Planned elective surgery during the study period , except for cataract surgery or vascular access surgery
Transfusion of red blood cells in the previous 2 months
Pregnant women
Contraindications for Mircera according to local prescribing information or as judged by the investigator

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
コホート

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Mean Age of Participants Treated With C.E.R.A 時間枠：Baseline (Week 0)	Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25	Baseline (Week 0)
Mean Weight of Participants Treated With C.E.R.A 時間枠：Baseline (Week 0)	Weight of the participants was measured at the Baseline and summarized with descriptive statistics.	Baseline (Week 0)
Number of Participants With Co-morbidity Treated With C.E.R.A 時間枠：Up to Week 24	Co-morbidity is the presence of one or more additional disorders (or diseases) co-occurring with a primary disease or disorder; or the effect of such additional disorders or diseases. Co-morbid participants with renal and urinary disorders, vascular disorders, metabolism and nutrition disorders were reported.	Up to Week 24
Mean Time Required to Achieve Target Hemoglobin Range 時間枠：Up to Week 24	The target range of hemoglobin (Hb) was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1	Up to Week 24
Percentage of Participants Achieved Target Range of Hemoglobin 時間枠：Up to Week 24	The target range of Hb was 10-12 gram/deciliter (g/dL). Time to achieve target range = (Date of Hb evaluation when participant achieved target Hb range at first time - visit date of first dosing) + 1. The percentage of participants with Hb < 10 g/dL at enrollment, achieving the target range of hemoglobin 10-12 g/dL was reported.	Up to Week 24
Percentage of Participants Who Had Received Treatment With Other Erythropoiesis-Stimulating Agents Maintaining Hb Level Within 1 Gram/Deciliter of Baseline Value During Study Period in Participants. 時間枠：Up to Week 24	Percentage of participants maintaining Hb level within 1 g/dL of baseline value during study period who had received treatment with other Erythropoiesis-Stimulating Agents (ESAs) were reported.	Up to Week 24

二次結果の測定

結果測定	メジャーの説明	時間枠
Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study 時間枠：Up to Week 24	For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.	Up to Week 24
Mean Time Spent by Participants in the Hb Target Range 時間枠：Up to Week 24	Maintenance of target Hb was evaluated by assessing the mean time spent by participants in target Hb range. The target Hb range in the study was 10-12 g/dL.	Up to Week 24
Evaluation of Route of Administration for C.E.R.A 時間枠：Up to Week 24	C.E.R.A. was administered by Intravenous (IV) and Subcutaneous (SC) route of administration. The frequency (number of injections) for both of these routes of administration used in the study was reported.	Up to Week 24
Evaluation of Dose Per Injection of C.E.R.A 時間枠：Up to Week 24	The dosing and titration of C.E.R.A treatment were at the discretion of the investigator in accordance with local clinical practice or approved prescribing information. Mean dose per injection of C.E.R.A received by participants was reported.	Up to Week 24
Number of Participants Received Concomitant Medications 時間枠：Up to Week 24	Medications that were used during the study treatment period (from the first dose date of study medication to the end of the study) were included as concomitant medications. The prescribed concomitant medications (in greater than or equal to 10% of participants) in the study were prazosin, torasemide, vitamin and nutritional supplements, omeprazole, amlodipine, calcium supplements, calcitriol, and clonidine. Participants treated with the each of these concomitant medications were reported.	Up to Week 24

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Hoffmann-La Roche

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2011年4月30日

一次修了 (実際)

2013年9月30日

研究の完了 (実際)

2013年9月30日

試験登録日

最初に提出

2012年8月30日

QC基準を満たした最初の提出物