RECRUITING Phase 2 ClinicalTrials.gov

Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents

Sponsor: Chinese University of Hong Kong • ClinicalTrials.gov ID: NCT07854561

Registry updated: 2026-10-02

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Description

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).

Interventions

Romiplostim (Drug)
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 (Drug)
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 (Drug)
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.

Eligibility criteria

Inclusion Criteria: 1. 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. 2. Male or female subjects at least 18 years of age. 3. Currently receiving darbepoetin or Mircera for anemia and iron supplement. 4. Receiving chronic maintenance hemodialysis for end-stage kidney disease. Note: Only hemodialysis patients will be enrolled because frequent blood sampling is required. 5. 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. 6. 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. 7. For non-transfusion-dependent patients, a minimum of two pre-transfusion or untransfused Hgb values are required. 8. Ability to sign informed consent. 9. Accessible vein for blood sampling. 10. Not pregnant or breastfeeding (in the case of women). Exclusion Criteria: 1. 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. 2. Hematological disease: sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia (thalassemia trait), or pure red cell aplasia. 3. 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. 4. A history of cancer. 5. Active infection or other chronic inflammatory conditions. 6. Baseline platelet count \>300 x 10\^9/L. 7. Vascular access problems or susceptibility to vascular access thrombosis.

Conditions

Anemia Associated With Chronic Kidney Disease

Locations

The Chinese University of Hong Kong — Hong Kong, Hong Kong

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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