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.
Completed · Phase 2
Conditions studied: Anemia, Renal Insufficiency, Chronic
In brief
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.
Key facts
- Study ID
- NCT03552393
- Run by
- Hoffmann-La Roche
- People needed
- 40
- Starts
- 2018-08-03
- Expected to finish
- 2021-07-19
- Last updated by the study team
- 2022-03-07
Who can join
Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- University of Alabama at Birmingham; Pediatric Nephrology — Birmingham, Alabama, United States
- Loma Linda University health — Loma Linda, California, United States
- Emory University School of Med; Pediatrics — Atlanta, Georgia, United States
- Children'S Mercy Hospital; Pediatric Nephrology — Kansas City, Missouri, United States
- RWJBarnabas Health — West Orange, New Jersey, United States
- East Carolina University; Brody School of Medicine — Greenville, North Carolina, United States
- UT Southwestern Medical Center; Pediatrics Dept. — Dallas, Texas, United States
- Hopital Jeanne De Flandre; Pediatrie — Lille, France
- Gh Necker Enfants Malades; Nephrologie — Paris, France
- Höpital Hautepierre; Pediatrie 1 — Strasbourg, France
- Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center — Budapest, Hungary
- Debreceni Egyetem Klinikai Központ; Gyermekklinika — Debrecen, Hungary
- Clinica Pediatrica II De Marchi — Milan, Lombardy, Italy
- Ospedale Infantile Regina Margherita; U.O. Autonoma di Nefrologia, Dialisi e Trapianto — Turin, Piedmont, Italy
- Vilnius University Children's Hospital — Vilnius, Lithuania
- Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy — Gdansk, Poland
- Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ — Krakow, Poland
- Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii — Lodz, Poland
- Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii — Torun, Poland
- Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii — Zabrze, Poland
- Hospital Universitari Vall d'Hebron; Servicio de Nefrologia — Barcelona, Spain
- Hospital Universitario Virgen del Rocio; Servicio de Nefrologia Pediatrica — Seville, Spain
Full record on ClinicalTrials.gov
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