Phase 2
Completed N=64
Study to Determine Optimum Intravenous Starting Dose of MIRCERA for Treatment of Pediatric Participants With Anemia and Chronic Kidney Disease on Hemodialysis
Renal Anemia
Source: ClinicalTrials.gov NCT00717366 ↗
Enrolled (actual)
64
Serious AEs
32.8%
Results posted
Sep 2017
Primary outcomePrimary: Change in Average Hb Concentration Between Baseline and Evaluation Period — 11.26; 11.08; -0.78; -0.15 g/dL
Summary
This sequential study will assess the efficacy and safety of multiple doses of intravenous (IV) methoxy polyethylene glycol-epoetin beta (MIRCERA), and will determine the optimum starting dose for maintenance treatment of anemia in children with chronic kidney disease on hemodialysis. Pediatric participants will remain on epoetin alfa, epoetin beta or darbepoetin alfa during the screening period, after which they will receive IV MIRCERA monthly, at a starting dose related to the previous weekly epoetin or darbepoetin alfa dose. Depending on the response achieved, another group may be selected to receive a higher or a lower dose.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Hb Concentration Between Baseline and Evaluation Period |
11.26; 11.08; -0.78; -0.15 | — |
| SECONDARY Number of Participants With an Average Hb Concentration During the Evaluation Period Within ±1 g/dL of Their Baseline Hb |
7; 27 | — |
| SECONDARY Number of Participants With an Average Hb Concentration During the Evaluation Period Above, Within or Below the Range of 10-12 g/dL |
0; 3; 9; 29; 3; 4 | — |
| SECONDARY Number of Participants With Blood Transfusions |
1; 2 | — |
| SECONDARY Change in Average Reticulocyte Count Between the Baseline and Evaluation Period |
46.08; 43.70; 23.38; 24.80 | — |
| SECONDARY Maximum Observed Serum Concentration (Cmax) of MIRCERA |
37700; 66100 | — |
| SECONDARY Area Under the Serum Concentration-Time Curve From 0 to 672 Hours (AUC0-672h) of MIRCERA |
3630000; 7170000 | — |
| SECONDARY Time to Reach Cmax (Tmax) of MIRCERA |
2.00; 2.00 | — |
| SECONDARY Apparent Terminal Phase Half-Life (t1/2) of MIRCERA |
147; 121 | — |
Eligibility Criteria
Inclusion Criteria
- Children aged 5-17 years (in Russia only: 12-17 years) with clinically stable chronic renal anemia
- Hemodialysis for greater than or equal to (>=) 8 weeks
- Intravenous stable maintenance treatment with epoetin alfa, epoetin beta, or darbepoetin alfa for >= 8 weeks before screening and with no weekly dose change >= 25 percent (%) (increase or decrease) during the 2 weeks of screening
Exclusion Criteria
- Overt gastrointestinal bleeding within 8 weeks before screening or during the screening period
- Red blood cell (RBC) transfusions within 8 weeks before screening or during the screening period
- Active malignant disease
- Pure red cell aplasia (PRCA) or history of PRCA
- Pregnant or lactating females
- Sexually active participants: not willing to use reliable contraception during treatment and for 90 days following the end of treatment
Data sourced from ClinicalTrials.gov (NCT00717366). 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.