NCT07854561Toboroz2. fázis
Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents
A Clinical Trial to Evaluate the Safety of the Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents (ESAs) in ESA-resistant Anemic Patients
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. okt. 2.
Rövid összefoglaló (regiszter, angolul)
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).
- Állapot (regiszter)
- Toboroz
- Fázis (regiszter)
- 2. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 12 (tervezett)
- Első benyújtás
- 2026. szept. 28.
- Kezdés
- 2026. aug. 11.
- Elsődleges befejezés
- 2027. febr. 1.
- Fő szponzor
- Chinese University of Hong Kong
- Betegségek
- Krónikus vesebetegség
- NCT-szám
- NCT07854561
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 2. fázis
- Tervezett résztvevők: 12
- 2026. aug. 11. és az elsődleges befejezés (2027. febr. 1.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
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Más betegség
- Anemia due to a cause other than chronic kidney disease (CKD), such as iron deficiency (defined as transferrin saturation [TSAT] <20%) or the presence of active bleeding or recent blood loss.
- Hematological disease: sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia (thalassemia trait), or pure red cell aplasia.
- Cardiovascular diseases, such as stroke or myocardial infarction, in the past 6 months, or poorly controlled hypertension, i.e., systolic blood pressure >160 mmHg or diastolic blood pressure >100 mmHg.
- A history of cancer.
- Active infection or other chronic inflammatory conditions.
- Vascular access problems or susceptibility to vascular access thrombosis.
Laborértékek
- Baseline platelet count >300 x 10\^9/L.
Kiket keres a vizsgálat
- Previously failed treatment with erythropoiesis-stimulating agents (ESAs) or had a poor response to ESAs. ESA resistance is defined as:
- Transfusion-dependent patients requiring a minimum dose of >=40,000 units of epoetin alfa/week for 8 weeks, or an equivalent dose of darbepoetin alfa (1.5 mg/kg/week or 120 mg every 2 weeks) or Mircera (100 mg every 2 weeks) for 8 weeks, with failure to achieve transfusion independence; OR
- Non-transfusion-dependent patients who fail to achieve a >=2 g increase in hemoglobin (Hgb) level sustained for >=4 weeks.
- Male or female subjects at least 18 years of age.
- Currently receiving darbepoetin or Mircera for anemia and iron supplement.
- Receiving chronic maintenance hemodialysis for end-stage kidney disease. Note: Only hemodialysis patients will be enrolled because frequent blood sampling is required.
- Having symptomatic anemia without transfusion and with Hgb levels <9.5 g/dL for <=8 weeks, or being RBC transfusion-dependent (i.e., >=2 units/month) for <=8 weeks.
- For non-transfusion-dependent patients (i.e., receiving <2 units/4 weeks for 8 weeks pre-study) who receive periodic transfusions, the mean 8-week pre-transfusion Hgb level will be used to determine protocol eligibility and response reference.
- For non-transfusion-dependent patients, a minimum of two pre-transfusion or untransfused Hgb values are required.
- Ability to sign informed consent.
- Accessible vein for blood sampling.
- Not pregnant or breastfeeding (in the case of women).
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
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| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| The Chinese University of Hong Kong | Hong Kong | Hongkong | Toboroz |
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