An Observational Study of Mircera (Methoxy Polyethylene Glycol-Epoetin Beta) in Chronic Kidney Disease Patients on Dialysis With Renal Anemia
2017년 6월 13일 업데이트: 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.
연구 개요
상태
완전한
정황
연구 유형
관찰
등록 (실제)
127
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Ahmedabad, 인도, 380005
- Ahmedabad Dialysis Centre
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Guwahati, 인도, 781007
- Excel Center
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Kolkata, 인도, 600054
- ESIS Hospital; Department of Nephrology
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Mumbai, 인도, 400083
- Vertex Hospital
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New Delhi, 인도, 110076
- Apollo Indraprastha Hospitals; Nephrology
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Pune, 인도, 411033
- Aditya Birla Memorial Hospital
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Delhi
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New Delhi, Delhi, 인도, 110060
- Sir Gangaram Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
확률 샘플
연구 인구
Patients with chronic kidney disease on dialysis receiving treatment with Mircera for chronic renal anemia
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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보병대
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Mean Age of Participants Treated With C.E.R.A
기간: Baseline (Week 0)
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Age was calculated on screening/Baseline visit day by using formula: Age = (Screening visit date - Date of birth)/365.25
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Baseline (Week 0)
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Mean Weight of Participants Treated With C.E.R.A
기간: Baseline (Week 0)
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Weight of the participants was measured at the Baseline and summarized with descriptive statistics.
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Baseline (Week 0)
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Number of Participants With Co-morbidity Treated With C.E.R.A
기간: Up to Week 24
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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.
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Up to Week 24
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Mean Time Required to Achieve Target Hemoglobin Range
기간: Up to Week 24
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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
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Up to Week 24
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Percentage of Participants Achieved Target Range of Hemoglobin
기간: Up to Week 24
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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.
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Up to Week 24
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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.
기간: Up to Week 24
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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.
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Up to Week 24
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Number of Participants Achieving Hb Target Range (10-12 Hb g/dL) at Least Once During the Study
기간: Up to Week 24
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For correction of anemia, number of participants achieving Hb target range (10-12 g/dL) at least once during the study were reported.
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Up to Week 24
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Mean Time Spent by Participants in the Hb Target Range
기간: Up to Week 24
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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.
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Up to Week 24
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Evaluation of Route of Administration for C.E.R.A
기간: Up to Week 24
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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.
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Up to Week 24
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Evaluation of Dose Per Injection of C.E.R.A
기간: Up to Week 24
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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.
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Up to Week 24
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Number of Participants Received Concomitant Medications
기간: Up to Week 24
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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.
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Up to Week 24
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2011년 4월 30일
기본 완료 (실제)
2013년 9월 30일
연구 완료 (실제)
2013년 9월 30일
연구 등록 날짜
최초 제출
2012년 8월 30일
QC 기준을 충족하는 최초 제출
2012년 8월 30일
처음 게시됨 (추정)
2012년 9월 3일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 7월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 6월 13일
마지막으로 확인됨
2017년 5월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .