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.

Roche

Status and phase

Completed

Phase 2

Conditions

Anemia

Renal Insufficiency, Chronic

Treatments

Drug: Mircera

Study type

Interventional

Funder types

Industry

Identifiers

NCT03552393

NH19708

2016-004779-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

3 months to 17 years old

Volunteers

No Healthy Volunteers

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 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