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.



Status:Recruiting
Conditions:Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Anemia
Therapuetic Areas:Hematology, Nephrology / Urology
Healthy:No
Age Range:Any - 17
Updated:3/2/2019
Start Date:May 8, 2018
End Date:October 28, 2021
Contact:Reference Study ID Number: NH19708 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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An Open-Label, Single-Arm, Multicenter Sudy to Ascertain the Optimal Starting Dose of MIRCERA® Given Subcutaneously for the Maintenance Treatment of Anemia in Pediatric Patients With Chronic Kidney Disease on Dialysis or Not Yet on Dialysis.

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.


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 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
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