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COMPLETED Phase 2

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.

NCT03552393 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Mircera

Study Locations (20)

Other

  • Hopital Jeanne De Flandre; Pediatrie — Lille
  • Gh Necker Enfants Malades; Nephrologie — Paris
  • Höpital Hautepierre; Pediatrie 1 — Strasbourg
  • Semmelweis University; 1st Department of Pediatrics, Pediatric Nephrology Center — Budapest
  • Debreceni Egyetem Klinikai Központ; Gyermekklinika — Debrecen
  • Vilnius University Children's Hospital — Vilnius
  • Uniwersyteckie Centrum Kliniczne; Klinika Chorob Nerek i Nadciśnienia Dzieci i Mlodziezy — Gdansk
  • Uniwersytecki Szpital Dziecięcy w Krakowie; Oddz.Nefrologii i Nadciśnienia Tętniczego/Stacja Dializ — Krakow
  • Instytut "Centrum Zdrowia Matki Polki; Klinika Pediatrii i Immunologii i Nefrologii — Lodz
  • Szpital Specjalistyczny dla Dzieci i Doroslych; Oddzial Kliniczny Pediatrii i Nefrologii — Torun
  • Szpital Kliniczny nr 1 im. prof. Szyszko; Oddz. Nefrologii Dzieciecej z Pododdziałem Dializoterapii — Zabrze

Alabama

  • University of Alabama at Birmingham; Pediatric Nephrology — Birmingham

California

  • Loma Linda University health — Loma Linda

Georgia

  • Emory University School of Med; Pediatrics — Atlanta

Missouri

  • Children'S Mercy Hospital; Pediatric Nephrology — Kansas City

New Jersey

  • RWJBarnabas Health — West Orange

North Carolina

  • East Carolina University; Brody School of Medicine — Greenville

Texas

  • UT Southwestern Medical Center; Pediatrics Dept. — Dallas

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2018-08-03
Est. Completion 2021-07-19
Phase Phase 2

Sponsor

Hoffmann-La Roche

758 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03552393

The ClinicalTrials.gov registry entry for NCT03552393 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 40 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hoffmann-La Roche, which has 758 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Anemia appearing as the primary indexed condition, and to 1 intervention — of which Mircera is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT03552393 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Other, Alabama, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT03552393 about?

NCT03552393 is a clinical study titled "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.". 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 da...

What is the current status of trial NCT03552393?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2018-08-03. Estimated completion is 2021-07-19.

What conditions does trial NCT03552393 study?

This clinical trial studies the following conditions: Anemia, Renal Insufficiency, Chronic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT03552393?

The interventions under investigation include: Mircera (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT03552393?

This trial is sponsored by Hoffmann-La Roche, which has 758 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT03552393 being conducted?

This trial has 20 study locations across Alabama, California, Georgia, Missouri, New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial