심장 수술 후 신장 손상 예방을 위한 일로포타제 알파
심장 절개 수술 후 신장 손상 위험이 있는 환자를 대상으로 일로포타제 알파의 효능과 안전성을 평가하기 위한 이중 맹검, 무작위, 위약 대조 시험
The aim of this clinical trial is to evaluate the efficacy and safety of two intravenous administrations of ilofotase alfa in patients at risk for renal damage following open heart surgery.
연구 개요
상세 설명
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled, 2-arm parallel group design trial in patients at risk for renal damage following open heart surgery. After screening and baseline assessments, eligible patients will be randomized 1:1 to either 2 doses of 128 mg ilofotase alfa, or 2 doses of placebo control. Randomization will be stratified by baseline eGFR and type of surgery. The patient will be treated with the investigational product (ilofotase alfa or placebo) at the same day before and after the surgery (Day 1). Follow-up clinic visits will be performed daily up to Day 5 for efficacy, safety, and pharmocokinetics assessments. A safety follow-up can be performed by telephone at Day 28. At Day 61, an end of trial visit will be done at site for efficacy, safety, and anti-drug antibodies assessments.
연구 유형
등록 (실제)
단계
- 2 단계
연락처 및 위치
연구 장소
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Amsterdam, 네덜란드
- Academisch Medisch Centrum Amsterdam
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Nijmegen, 네덜란드
- Stichting Radboud University Medical Center
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Rotterdam, 네덜란드
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
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Essen, 독일
- Universität Duisburg-Essen, Klinik für Thorax- und Kardiovaskuläre Chirurgie
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Munich, 독일
- Deutsches Herzzentrum Muenchen Des Freistaates Bayern Klinik An Der Technischen Universitaet Muenchen
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Münster, 독일
- Westfaelische Wilhelms-Universitaet Muenster
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Tübingen, 독일
- Universitätsklinikum für Anästhesiologie und Intensivmedizin, Universitätsklinikum Tübingen
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Genk, 벨기에
- Ziekenhuis Oost Limburg
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Ghent, 벨기에
- Universitair Ziekenhuis Gent
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Roeselare, 벨기에
- Algemeen Ziekenhuis Delta
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Bern, 스위스
- Universitätsspital Bern Universitätsklinik für Herzchirurgie
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Lausanne, 스위스
- Centre hospitalier universitaire vaudois (CHUV)
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London, 영국
- Guy's and St Thomas' NHS Foundation Trust
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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Age ≥18 years
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Planned for one of the following types of open chest cardiovascular surgery with the use of cardiopulmonary bypass pump (CPB):
- 1. combined valve and CABG surgery; 2. aortic valve plus aortic root and/or ascending aorta (excluding aortic arch)
- CABG with 3 or more distal anastomoses
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Screening eGFR ≥25 mL/min/1.73m2 and ≤65 mL/min/1.73m2
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Female patients of childbearing potential agreeing to use effective contraception within IP treatment and 14 days thereafter
Post-menopausal females do not require contraception during the trial.
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Male patients agreeing to refrain from donating sperm, use a male condom when having sexual intercourse and in case their partner is of childbearing potential they must agree to use adequate and effective contraception method (see inclusion criterion 4) within IP treatment and 14 days thereafter
The five most important Exclusion Criteria:
- Body weight ≤55 kg
- Known or suspected glomerulonephritis (other than diabetic kidney disease) or other systemic vasculitis
- Confirmed or treated endocarditis requiring antimicrobial or antiviral treatment within 30 days prior to surgery or other current active infection requiring antimicrobial or antiviral treatment within 14 days prior to surgery
- Known chronic liver disorder with Child-Pugh C classification
- Current planned (or scheduled) surgical intervention under conditions of circulatory arrest, including planned deep hypothermic circulatory arrest
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: 위약
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After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1) |
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실험적: 일로포타제 알파
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After dilution of the concentrate, the investigational medicinal product will be administered by intravenous infusion for 1 hour at the same day before and after the surgery (Day 1) |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Serum Creatinine Level Ratio
기간: From Baseline (Day -1/1) to Day 5
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Ratio between the highest serum creatinine value post-surgery (post-surgery Day 1 and Days 2, 3, 4, and 5) and baseline serum creatinine (pre-surgery, Day -1/Day 1). The values at post-surgery Day 1 and Days 2, 3, 4, and 5 compared to the value at baseline (Day -1/Day 1) are used to calculate the serum creatinine ratio. The reported means and standard deviations are based on patient-level ratios and include observed and imputed values. |
From Baseline (Day -1/1) to Day 5
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessment of Major Adverse Kidney Events (MAKE) 60
기간: 60 days
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Major adverse kidney events (MAKE) 60, defined as died up to and including Day 61, have received or are receiving new renal replacement therapy (RRT) up to and including Day 61, or have a decrease in estimated glomerular filtration rate (eGFR) ≥25% on Day 61 compared to the pre-surgery baseline eGFR reference value. With Day 1 being the day of surgery. |
60 days
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(Serious) Adverse Events up to Day28
기간: Day1 to Day28
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All AEs that occured up to and including Day 28 or patient's trial completion, whichever occurs first. |
Day1 to Day28
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Cumulative AKI Severity (Area Under the Curve)
기간: From Day 1 to Day 5
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Area under the curve of daily AKI severity stage/grade (0-3) from Day 1 to Day 5; higher values indicate greater cumulative AKI severity |
From Day 1 to Day 5
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Number of Participants With KDIGO AKI
기간: From Day 1 to Day 5
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KDIGO AKI stage was measured daily from Day 1 to Day 5 after surgery. A participant was counted as 'participant with KDIGO AKI', if the AKI stage was at least one day >0 from Day 1 to Day 5 after surgery. |
From Day 1 to Day 5
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Assessment of Length of Stay in the Intensive Care Unit
기간: From Baseline to Day 28
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Length of stay in the intensive care unit (ICU) in days after the initial surgery |
From Baseline to Day 28
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공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Pickkers, Prof, MD, PhD, Radboud University Medical Center
간행물 및 유용한 링크
일반 간행물
- Tellez Garcia JM, Steenvoorden T, Bemelman F, Hilhorst M, Tammaro A, Vogt L. Purinoreceptor P2X7 in Extracellular ATP-Mediated Inflammation through the Spectrum of Kidney Diseases and Kidney Transplantation. J Am Soc Nephrol. 2025 Mar 28;36(9):1823-1843. doi: 10.1681/ASN.0000000711.
- Mourisse L, Ostermann M, Thiessen S, Dumoulin A, Vlaar APJ, Hoste E, Mosbahi S, Schneider A, Zarbock A, Boehm J, Rosenberger P, Thielmann M, Dubois E, Powell-Tuck J, Baig K, Renette W, Meex I, Klop-Rhiel M, Opschoor K, Vandenberghe W, Siepe M, Strauss C, Wirth F, Winkel M, Hof L, Kraan M, Bernholz J, Pickkers P; study team. A multicenter randomized, double-blinded placebo-controlled phase 2 trial to evaluate safety and efficacy of ilofotase alfa in patients at risk for kidney injury following open heart surgery. Intensive Care Med. 2026 Sep 21. doi: 10.1007/s00134-026-08596-y. Online ahead of print.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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