Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents
报名条件（概要）
- 年龄：18 Years – 不限
- 性别：不限
- 健康志愿者：不接受
完整入排标准请以官方页面为准。
开展国家/地区
Hong Kong
药品与企业信息
Romiplostim is a thrombopoietin receptor agonist (TPO-RA) administered as an add-on therapy to erythropoiesis-stimulating agents (ESAs) in patients with ESA-resistant anemia. In this study, romiplostim is given by subcutaneous injection once weekly for 3 consecutive weeks at a dose of 0.2, 0.5, or 1 mg/kg. It is intended to stimulate hematopoietic stem cells and megakaryocyte-erythroid progenitors to correct ESA-induced progenitor depletion while limiting platelet increase through stem cell competition with concomitant ESA therapy.
Darbepoetin alfa is an erythropoiesis-stimulating agent (ESA) used as standard therapy for anemia in chronic kidney disease. Participants continue their pre-study darbepoetin alfa dose together with iron supplementation. The ESA dose is initially unchanged; it may be reduced according to product labeling if hemoglobin rises too rapidly (e.g., \>1 g/dL over 2 weeks). It is given as part of the combination therapy with romiplostim.
Methoxy polyethylene glycol-epoetin beta is a long-acting erythropoiesis-stimulating agent (ESA) used for anemia in chronic kidney disease. Participants continue their pre-study Mircera dose together with iron supplementation. The ESA dose is initially unchanged; it may be reduced according to product labeling if hemoglobin rises too rapidly (e.g., \>1 g/dL over 2 weeks). It is given as part of the combination therapy with romiplostim.
研发企业
试验官方登记的主要申办方；研究机构申办时会显示相应机构名称。
生产企业
公开药品批准资料或正式说明书暂未提供明确的生产企业信息。
研发企业与生产企业可能不是同一家。研究阶段药品可能尚未公布生产企业；生产企业仅取自美国上市原研药说明书所列企业（不含仿制药），不作推测；仅在其他国家上市的药品暂无法显示。
研究简介（原文）
The goal of this Phase 2 clinical trial is to learn if adding romiplostim to standard erythropoiesis-stimulating agent (ESA) therapy is safe and tolerated in adults with chronic kidney disease who are on hemodialysis and have anemia that has not responded well to ESAs. The study will mainly check platelet counts and side effects. The main questions it aims to answer are: How many participants keep platelet counts within a normal range during and after treatment? How many participants have platelet counts that rise above the normal range? What medical problems or side effects occur after romiplostim is added to ESA therapy? Researchers will study three dose levels of romiplostim (0.2, 0.5, and 1 mg/kg) in small groups of participants. There is no placebo group. All participants will receive romiplostim plus their usual ESA and iron supplement. The study will also measure changes in hemoglobin and iron-related blood markers. Participants will: Receive romiplostim as an injection under the skin once weekly for 3 weeks. Each participant will be assigned to one of three dose groups. Continue their usual ESA therapy (darbepoetin or Mircera) and iron supplement. Have blood tests to check platelet counts, hemoglobin, and other blood and iron measures. Blood tests will be frequent at first and then less often. Visit the clinic regularly for up to 24 weeks, with a follow-up visit about 4 weeks after the end-of-treatment visit. Have other safety checks, such as vital signs, physical exams, and electrocardiograms (ECGs).
适应症
主动联系研究团队
这项试验目前在中国大陆没有研究中心
这种情况下，直接发"入组咨询"往往会被回复"您所在地区没有中心"。更有效的做法是申请同情用药／扩展准入（由主治医生一同提出），或询问能否到最近的境外中心参加。下面已为您切换到对应的信件版本。
查看完整申请路径与成功率说明 →总联系人（申办方／研究总部）
- Xiaoyu Yan, PhDxiaoyuyan@cuhk.edu.hk85239435012
中国／港澳台研究中心
- The Chinese University of Hong KongHong Kong，Hong Kong
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英文版（发给研究团队）
Dear Study Team, I am a patient in China and I am interested in participating in your clinical trial: Study Title: Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents ClinicalTrials.gov Identifier: NCT07854561 Sponsor: Chinese University of Hong Kong Investigational product: Romiplostim, darbepoetin alfa, Methoxy Polyethylene Glycol-Epoetin Beta About me: - Age: (please fill in) - Sex: (please fill in) - Confirmed diagnosis and stage: (please fill in) - Biomarkers / genetic testing: not available - Prior and current treatments: (please fill in) - Performance status (ECOG): not assessed - Current location: China - Travel ability: (please fill in) Could you please let me know: 1. Whether I might be eligible for this study; 2. Which site would be closest and most practical for me, and whether remote pre-screening is possible; 3. What documents (medical records, pathology or imaging reports, recent labs) I should prepare for pre-screening. I can provide English translations of my medical records. Thank you very much for your time and help. Kind regards, (your name) (your email / phone with country code)
中文对照（供您核对）
尊敬的研究团队： 我是一位来自中国的患者，希望咨询参加以下临床试验的可能： 研究名称：Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents 试验编号：NCT07854561 申办方：Chinese University of Hong Kong 研究药物：Romiplostim、darbepoetin alfa、Methoxy Polyethylene Glycol-Epoetin Beta 我的基本情况： - 年龄：（请填写） - 性别：（请填写） - 确诊疾病与分期：（请填写） - 基因／标志物检测：暂无 - 既往及当前治疗：（请填写） - 体能状态（ECOG）：未评估 - 目前所在城市：中国 - 可前往范围：（请填写） 想请教三个问题： 1. 我是否可能符合本研究的入组标准？ 2. 哪个中心对我最方便可行？能否远程预筛？ 3. 预筛需要准备哪些资料（病历、病理、影像、近期化验）？ 我可以提供英文翻译版病历。感谢您的时间与帮助。 顺祝安康 （您的姓名） （您的邮箱／带国际区号的电话）
提示：请与主治医生一起发信——由医生署名的申请，回复率远高于患者单独发信。首封邮件不要附身份证号等敏感信息。研究团队通常在 3–10 个工作日内回复，两周无回音可礼貌追问一次。
下一步怎么做？
- 把本页信息带给您的主治医生，评估是否适合参加。
- 点击下方按钮打开官方注册页，查看研究中心联系方式。
- 直接联系研究团队咨询报名事宜（通常有中文同声翻译服务可协助沟通）。