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.

NCT ID: NCT03552393

Last Updated: 2022-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-03
• Study Completion Date: 2021-07-19

Brief 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.

Conditions

Anemia; Renal Insufficiency, Chronic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mircera

Mircera will be administered subcutaneously once every 4 weeks

Group Type: EXPERIMENTAL

Mircera

Intervention Type: DRUG

The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.

Interventions

Mircera

The initial dose of Mircera will be one of nine starting doses corresponding to the prefilled syringe strengths based on the total weekly erythropoiesis-stimulating agent (ESA) dose during the screening period.

Intervention Type: DRUG

Other Intervention Names

Methoxy polyethylene glycol-epoetin beta

Eligibility Criteria

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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

Countries

United States; France; Hungary; Italy; Lithuania; Poland; Spain

References

Warady BA, Meyer Reigner S, Tirodkar C, Drozdz D. Subcutaneous C.E.R.A. for the Maintenance Treatment of Anemia in Pediatric Patients With CKD: A Phase 2, Open-Label, Single-Arm, Multicenter Study. Am J Kidney Dis. 2023 Jun;81(6):684-694.e1. doi: 10.1053/j.ajkd.2022.11.006. Epub 2022 Dec 29.

Reference Type: DERIVED

PMID: 36587890 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-004779-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NH19708

Identifier Type: -

Identifier Source: org_study_id