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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. | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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.

An Open-Label, Single-Arm, Multicenter Study 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.

NCT03552393•Hoffmann-La Roche

View on ClinicalTrials.gov

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.

Eligibility

Age

0 - 17 years

Sex

ALL

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
+4 more criteria

Locations (22)

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

Key Dates

Start Date

August 3, 2018

Primary Completion Date

July 19, 2021

Completion Date

July 19, 2021

Last Updated

March 7, 2022

Enrollment

ACTUAL participants

Conditions

AnemiaRenal Insufficiency, Chronic

Interventions

Mircera

DRUG

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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NCT03520647

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 7, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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.

Inclusion Criteria

Exclusion Criteria

Natural History of Acquired and Inherited Bone Marrow Failure Syndromes

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