Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
A Multi-center, Prospective, Observational Study to Evaluate the Safety and Efficacy of Kremezin IDT/Fine Gran in Progressive Chronic Kidney Disease Patients.
This study will be conducted under routine clinical practice in adults diagnosed with advanced chronic renal failure for whom treatment with Kremezin immediate-release tablets or Kremezin fine granules has been determined as part of standard clinical care. Kremezin will be prescribed and administered in accordance with the approved product labeling. Study data will be collected at up to three time points through Week 48: baseline, Week 24, and Week 48. Effectiveness will be assessed using serum creatinine (Scr), estimated glomerular filtration rate (eGFR), and the investigator's overall assessment; treatment satisfaction and safety information will also be collected.
연구 개요
상태
상태
정황
정황
상세 설명
This is a multicenter, prospective, observational study to evaluate the effectiveness and safety of Kremezin immediate-release tablets or Kremezin fine granules in adults diagnosed with advanced chronic renal failure. During routine clinical visits, the investigator will determine whether Kremezin treatment is appropriate. The investigator will prescribe the selected formulation in accordance with the product labeling and routine clinical practice. The treatment decision must be made before the participant provides consent to participate in the study and without any study-related intervention.
Adults will receive Kremezin immediate-release tablets or fine granules at the approved dosage-2 g three times daily (4 tablets per dose or 1 sachet per dose, respectively)-for the treatment period determined in routine care, with study data collected through Week 48. Scr and eGFR will be recorded at baseline, Week 24 (±3 weeks), and Week 48 (±4 weeks). At Weeks 24 and 48, the investigator will also assess overall effectiveness and treatment satisfaction and collect safety information. Blood pressure and laboratory results will be collected when available. The study will not require additional treatment or visits beyond routine clinical care.
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 연락처
연구 연락처
- 이름: Yongan Jeong
- 전화번호: +82-31-5176-4673
- 이메일: yongan.jeong@inno-n.com
연구 연락처 백업
- 이름: Nayoung Lee
- 전화번호: +82-31-5176-4675
- 이메일: nayoung.lee1@inno-n.com
연구 장소
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Seoul, 대한민국
- 모병
- HK inno.N
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연락하다:
- Ahrong Kim
- 전화번호: +82-31-5176-4666
- 이메일: ahrong.kim@inno-n.com
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연락하다:
- Nayoung Lee
- 전화번호: +82-31-5176-4675
- 이메일: nayoung.lee1@inno-n.com
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
3125
설명
Inclusion Criteria:
- Adults aged 19 years or older diagnosed with advanced chronic renal failure.
- Individuals who voluntarily decide to participate and provide written informed consent.
Exclusion Criteria:
- Individuals for whom Kremezin immediate-release tablets or Kremezin fine granules are contraindicated according to the product labeling.
- Individuals with AST or ALT levels at least three times the upper limit of normal.
- Individuals with chronic alcoholism.
- Individuals with an active or progressive infection.
- Pregnant or breastfeeding individuals.
- Individuals with a history of dialysis.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with an effective overall assessment at Week 24
기간: Baseline to Week 24 (Week 24 ±3 weeks)
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Overall effectiveness will be assessed by the investigator based on serum creatinine (Scr) and estimated glomerular filtration rate (eGFR). Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis. |
Baseline to Week 24 (Week 24 ±3 weeks)
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Proportion of participants with an effective overall assessment at Week 48
기간: Baseline to Week 48 (Week 48 ±4 weeks)
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Overall effectiveness will be assessed by the investigator based on Scr and eGFR. Participants will be classified as effective, ineffective, or unevaluable; unevaluable participants will be excluded from the analysis. |
Baseline to Week 48 (Week 48 ±4 weeks)
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Change from baseline in serum creatinine (Scr) at Weeks 24 and 48
기간: Baseline to Week 24 and Week 48
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Change = Scr at Week 24 or Week 48 - Scr at baseline. |
Baseline to Week 24 and Week 48
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Change from baseline in estimated glomerular filtration rate (eGFR) at Weeks 24 and 48
기간: Baseline to Week 24 and Week 48
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eGFR will be calculated using the CKD-EPI equation. Change = eGFR at Week 24 or Week 48 - eGFR at baseline. |
Baseline to Week 24 and Week 48
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Mean treatment satisfaction score at Weeks 24 and 48
기간: Week 24 and Week 48
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Treatment satisfaction will be assessed on a 7-point scale, from 1 (extremely dissatisfied) to 7 (extremely satisfied). |
Week 24 and Week 48
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
기타 연구 ID 번호
- IN_KRM_N01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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