💬In plain words
What the trial is, and whether it could suit you
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 he
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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