Romiplostim added to standard ESA therapy in adults on hemodialysis with ESA-resistant anemia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 2 interventional trial in adults undergoing chronic hemodialysis with anemia that remains resistant to erythropoiesis-stimulating agents. Participants receive romiplostim at one of three dose levels (0.2, 0.5, or 1 mg/kg) in addition to their usual ESA and iron therapy, with no placebo group. The study mainly monitors platelet counts, safety, and adverse events, while also assessing hemoglobin and iron-related markers. Primary questions focus on the proportion maintaining normal platelet range, those with platelets rising above normal, and the safety profile of the combination. The trial aims to determine tolerability and preliminary safety signals to inform future trials.

Why it matters

Who can join: the full rules

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.

Where it's running

• The Chinese University of Hong Kong
  Hong Kong, Hong Kong Recruiting

Study contacts

• Study coordinator: Xiaoyu Yan, PhD
• Email: xiaoyuyan@cuhk.edu.hk
• Phone: 85239435012

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.