Phase 2
Completed N=40
Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.
Anemia · Renal Insufficiency, Chronic
Source: ClinicalTrials.gov NCT03552393 ↗
Enrolled (actual)
40
Serious AEs
32.5%
Results posted
Mar 2022
Primary outcomePrimary: Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient — 11.05; 0.48 grams/deciliter (g/dL)
Summary
Ascertain the starting dose of Mircera given subcutaneously for the maintenance treatment of anemia in pediatric participants with chronic kidney disease (CKD) on dialysis or not yet on dialysis when switching from stable subcutaneous (SC) maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient |
11.05; 0.48 | — |
| SECONDARY Number of Participants With an Average Hb Concentration During the Evaluation Period Within ± 1 g/dL of Their Baseline Hb and Above, Within or Below the Range of 10-12 g/dL |
15; 19; 4; 12; 24; 2 | — |
| SECONDARY Mean Hb Values and Change From Baseline |
11.02; 11.69; 0.67; 11.21; 0.19; 11.68 | — |
| SECONDARY Change in Mircera Dose Over Time |
75.00; 75.00; 0.00; 50.00; 0.00; 50.00 | — |
| SECONDARY Ratio of Mircera Starting Dose (Week 1) to the Dose at Week 17 |
1.44 | — |
| SECONDARY Number of Participants With Adverse Events by Severity as Assessed by Highest World Health Organization (WHO) Toxicity Grade |
25; 8 | — |
| SECONDARY Bioavailability (F) of Mircera in Pediatric Participants Based on Population PK Model |
67 | — |
Eligibility Criteria
Inclusion Criteria
- Pediatric participants 3 months to 17 years of age with clinically stable chronic renal anemia
- CKD with estimated glomerular filtration rate (eGFR) of 65% or Kt/V > 1.2 for participants on HD three times per week.
Participants with fewer than or more than three HD sessions per week should have a weekly Kt/V≥ 3.6.
- Baseline Hb concentration 10.0-12.0 g/dL determined from the mean of two Hb values measured at Visit 1 (Week -3) and Visit 2 (Week -1)
- Stable SC maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa with the same dosing interval for at least 6 weeks before the first dose of Mircera
- Stable dose of epoetin alfa, epoetin beta, or darbepoetin alfa treatment with no weekly dose change > 25% (increase or decrease) for at least 4 weeks before the first dose of Mircera
- Adequate iron status defined as ferritin≥100 ng/mL or transferrin saturation (TSAT)≥ 20% (or percentage of hypochromic red cells < 10%); mean of two values measured during screening.
Exclusion Criteria
- Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- RBC transfusions within 8 weeks before screening or during the screening period
- Hemoglobinopathies (e.g., homozygous sickle-cell disease, thalassemia of all types) Hemolytic anemia, Active malignant disease
- PD subjects with an episode of peritonitis within the past 30 days prior to screening and/or during the screening period
- Uncontrolled or symptomatic inflammatory disease (e.g., systemic lupus erythematosus)
- Uncontrolled hypertension as assessed by the investigator
- Epileptic seizures within 3 months prior to screening and during the screening period
- Administration of any investigational drug within 4 weeks prior to screening or planned during the study
- Severe hyperparathyroidism (intact parathyroid hormone [PTH]≥ 1000 pg/mL or whole PTH≥ 500 pg/mL) or biopsy-proven bone marrow fibrosis
- Kidney transplant with use of immunosuppressive therapies known to exacerbate anemia
- Known hypersensitivity to recombinant human erythropoietin (EPO), polyethylene glycol, or any constituent of the study drug formulation
- Anti-EPO antibody (AEAB)-mediated pure red cell aplasia (PRCA) or history of AEAB mediated PRCA or positive AEAB test result in the absence of PRCA
- High likelihood of early withdrawal or interruption of the study (e.g., planned living donor kidney transplant within 5 months of study start)
- Planned elective surgery during the entire study period
Data sourced from ClinicalTrials.gov (NCT03552393). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.