Ascertain the Optimal Starting Dose of Mircera Given Subcutaneously for Maintenance Treatment of … (NCT03552393) | Clinical Trial Compass
CompletedPhase 2
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.
United States40 participantsStarted 2018-08-03
Plain-language 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.
Who can participate
Age range3 Months – 17 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 \< 45 mL/min/1.73 m2 (determined by the Bedside Schwartz formula) or dialysis treatment for at least 8 weeks before the first dose of Mircera
* For participants on peritoneal dialysis (PD): a weekly Kt/V≥ 1.8
* For participants on hemodialysis (HD): adequate HD, urea reduction ratio (URR) \> 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 …
What they're measuring
1
Change in Hemoglobin (Hb) Concentration Between the Baseline and the Evaluation Period for Each Patient