임상 레이더 AI | ||
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임상시험 NCT07494409은(는) Anemia Due to Chronic Kidney Disease에 대해 모집중 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
A Study of AND017 to Evaluate Efficacy and Safety in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia 3상 300 무작위 배정 오픈 라벨
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT07494409은(는) 치료을(를) 알아보기 위한 연구입니다. 이 연구는 Anemia Due to Chronic Kidney Disease에 대해 진행되며, 3상 중재연구으로 현재 상태는 모집중입니다. 연구는 2025년 10월 31일에 시작되어 300명의 참여자를 모집하고 있습니다. Kind Pharmaceuticals LLC이(가) 진행하며, 2027년 4월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2026년 3월 27일에 갱신되었습니다.
간단한 개요
This is a phase III, randomized, open-label, active-controlled study to evaluate the safety and efficacy of AND017 in anemic patients with End-Stage-Kidney-Disease (ESKD)
공식 제목
A Phase 3, Multi-center, Randomized, Open-Label, Active-Controlled, Efficacy and Safety Study of AND017 to Treat Anemia in Dialysis-Dependent Chronic Kidney Disease (DD-CKD) Patients With Anemia
질환명
Anemia Due to Chronic Kidney Disease기타 연구 식별자
- AND017-CN-302
- CTR20253615 (기타 식별자) (China National Medical Products Administration)
NCT 번호
실제 연구 시작일
2025-10-31
최신 업데이트 게시
2026-03-27
예상 연구 완료일
2027-04-30
계획된 등록 인원
300
연구종류
중재연구
단계/상
3상
상태
모집중
키워드
anemia
CKD
ESKD
CKD
ESKD
주요 목적
치료
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
실험적AND017 | AND017 capsules AND017 capsules administered orally with a starting dose of 10 mg TIW |
활성 대조군Erythropoiesis Stimulating Agents (ESA) | ESA ESA injection and dose based on package insert and local practice |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Evaluate the efficacy of AND017 compared with the active control in maintaining Hb levels in anemic patients with ESKD | The mean Hb levels averaged over Week 23-27 | From Week 23 to Week 27 |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
The percentage of responders | Responder is defined as: for participants with baseline Hb ≥ 9.0 g/dL, mean Hb ≥10.0 g/dL and a change from baseline ≥ -1.0 g/dL during Weeks 23-27 | From baseline to Week 27 |
Percentage of participants that maintained Hb level over target lower limit | Percentage of participants with mean Hb ≥ 10.0 g/dL averaged over Weeks 5-27 | From Week 5 to Week 27 |
Maintenance of Hb within 10.0-12.0 g/dL after initial achievement ≥10.0 g/dL during the entire study treatment period. | During entire study treatment period, the percentage of participants in which Hb, after first reaching ≥ 10.0 g/dL, is maintained within the target range of 10.0-12.0 g/dL (inclusive) | From baseline to Week 53 |
Incidence of extreme Hb levels of ≥13.0 g/dL or <7.5 g/dL during the entire study treatment period | During the entire study treatment period, the percentage of participants in which Hb is ≥ 13.0 g/dL or \< 7.5 g/dL | From baseline to Week 53 |
Incidence of excessive erythropoiesis | During the entire study treatment period, the percentage of participants with an Hb increase ≥ 1.0 g/dL within any 2-week period and an Hb increase ≥ 2.0 g/dL within any 4-week period respectively | From baseline to Week 53 |
The cumulative incidence of Hb non-response | The cumulative incidence of Hb non-response is defined as Hb \< 10.0 g/dL and an increase from baseline \< 1.0 g/dL averaged over Weeks 5-27 | From baseline to Week 27 |
Mean Hb change from baseline averaged over Weeks 5-27 | Mean Hb change from baseline averaged over Weeks 5-27 | From baseline to Week 27 |
Mean Hb change from baseline averaged over Weeks 23-27 | Mean Hb change from baseline averaged over Weeks 23-27 | From baseline to Week 27 |
Mean Hb change from baseline averaged over Weeks 13-17 | Mean Hb change from baseline averaged over Weeks 13-17 | From baseline to Week 17 |
Mean Hb change from baseline averaged over Weeks 27-53 | Mean Hb change from baseline averaged over Weeks 27-53 | From baseline to Week 53 |
Mean Hb change from baseline averaged over Weeks 49-53 | Mean Hb change from baseline averaged over Weeks 49-53 | Mean Hb change from baseline averaged over Weeks 49-53 |
During the entire treatment period, mean Hb at each visit | During the entire treatment period, mean Hb at each visit | From baseline to Week 53 |
The use of intravenous iron during the entire study treatment period | The percentage of participants that have received intravenous iron during the entire study treatment period | From baseline to Week 53 |
The mean weekly dose of intravenous iron during the entire treatment period | The mean weekly dose of intravenous iron during the entire treatment period | From baseline to Week 53 |
The time to first initiation of intravenous iron during the entire treatment period | The time to first initiation of intravenous iron during the entire treatment period | From baseline to Week 53 |
참여 도우미
적격성 기준
연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
- Receiving stable hemodialysis (including combination methods such as hemodiafiltration or hemofiltration), peritoneal dialysis for ESKD for a minimum of 16 weeks prior to randomization and determined by the Investigator to be compliant with dialysis treatment prescription.
- Patient must have been on IV or SC of an approved ESA under the prescription for at least 6 weeks
- The mean of two hemoglobin values during screening must be 9.0-12.0 g/dL.
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)<3× upper limit of normal (ULN)
- Transferrin saturation ≥20% or ferritin ≥100 ng/mL at screening test
- Serum folate and vitamin B12 ≥ lower limit of normal (LLN) at screening test
- Concurrent retinal neovascular lesions requiring treatment
- Chronic inflammatory disease other than glomerulonephritis that could impact erythropoiesis or concurrent autoimmune disease with inflammatory symptoms
- History of gastric/intestinal resection considered to affect the absorption of drugs in the gastrointestinal tract or concurrent symptomatic gastroparesis despite being on treatment
- Uncontrolled hypertension, defined as patients with hypertension having more than one of three systolic blood pressure >180 mmHg, or diastolic blood pressure >110 mmHg during the screening assessment
- Concurrent congestive heart failure (New York Heart Association \[NYHA\] Class III or higher)
- History of stroke, transient ischemic attack (TIA), myocardial infarction, thromboembolic event (deep vein thrombosis, DVT), pulmonary embolism, or lung infarction within 24 weeks before the screening assessment
- Participants with a history of significant liver disease or active liver disease
- History of a seizure disorder or any occurrence of seizures in the past
- Serum albumin (ALB) < 2.5 g/dL at screening test
- Prior ESA/hypoxia-inducible factor-prolyl hydroxylase inhibitor (HIF-PHI) treatment caused total bilirubin >1.5xULN, or AST/ALT/ ALP>3xULN, or serious liver disease (acute or active chronic hepatitis, cirrhosis, etc.)
- Any prior functioning organ transplant or a scheduled organ transplantation, or anephric
Kind Pharmaceuticals LLC연구 대표 연락처
연락처: Yusha Zhu, MD, PhD, 6467252552, [email protected]
1 1개국에 임상시험 장소
Fudan Univeristy Zhongshan Hospital, Shanghai, 200032, China
Xiaoqiang Ding, 책임연구자
모집중