Combination Therapy of Romiplostim and Erythropoiesis-stimulating Agents

What Was Tested

This registered phase 2 trial tested Romiplostim for anemia.

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?

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

More on the Plan

Treatment options for ESA-resistant anemia remain limited, and many patients eventually require recurrent transfusions.

Thrombopoietin receptor agonists (TPO-RAs), such as romiplostim, can stimulate the expansion of hematopoietic stem cells and early erythroid progenitors, potentially correcting ESA-induced progenitor depletion.

Because megakaryocytic and erythroid lineages share a common megakaryocyte-erythroid progenitor (MEP), concomitant ESA therapy may preferentially recruit MEPs into the erythroid lineage and indirectly inhibit platelet production through stem cell competition.

This provides a mechanistic rationale for combining a TPO-RA with an ESA to treat ESA-resistant anemia while limiting the risk of thrombocytosis.

Who Took Part

Enrollment: 12 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Previously failed treatment with erythropoiesis-stimulating agents (ESAs) or had a poor response to ESAs. ESA resistance is defined as:. 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. For non-transfusion-dependent patients, a minimum of two pre-transfusion or untransfused Hgb values are required.

The full record lists 12 inclusion and 7 exclusion criteria; among the exclusions: hematological disease: sickle cell disease, myelodysplastic syndromes, bone marrow fibrosis, hematologic malignancy, myeloma, hemolytic anemia, thalassemia (thalassemia trait), or pure red cell aplasia; A history of cancer; active infection or other chronic inflammatory conditions.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Romiplostim study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-08-11 with completion listed for 2027-02-01.

It ran at 1 site in Hong Kong.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Incidence of platelet counts exceeding the normal range (time frame: From baseline through Week 24 and safety follow-up (Week 28)). Proportion of patients maintaining platelet counts within the normal range (time frame: From baseline through Week 24 (end of treatment) and safety follow-up (Week 28)). Number and severity of adverse events (AEs) following romiplostim administration (time frame: From informed consent through Week 28 (end of follow-up)).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Romiplostim in 12 people with anemia.

Its size is small, so on its own it can only give an early look.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Romiplostim compound page, Anemia research.