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NCT03552393 · ClinicalTrials.gov registry record · 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.

A Phase 2 study of Anemia and Renal Insufficiency, Chronic, sponsored by Hoffmann-La Roche.

Completed
Registry status
Phase 2
Development phase
40
Enrollment target
20
Study locations

NCT03552393: Completed Phase 2 study of Anemia and Renal Insufficiency, Chronic, sponsored by Hoffmann-La Roche.

NCT03552393 is a Phase 2 study of Anemia and Renal Insufficiency, Chronic that has completed, run by Hoffmann-La Roche. The registered enrollment target is 40 participants, below the 427-participant average among 72 other Anemia trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03552393, a Phase 2 study of Anemia and Renal Insufficiency, Chronic, has completed, sponsored by Hoffmann-La Roche.

COMPLETED
Registry status
Phase 2
Development phase
40 participants
Enrollment target
20
Study locations

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.

Primary Outcome

The Hb change from baseline was calculated on a per-participant basis using an individual's average for both the baseline and evaluation periods and taking the difference. The baseline period was defined as the time between the day of first study dose and the previous 35 days. The evaluation period was defined as the period between Week 17 and Week 21, inclusive.

Conditions Studied

Anemia Renal Insufficiency, Chronic

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
Hoffmann-La Roche

909 total trials

What the finished NCT03552393 record still lists

NCT03552393 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 427-participant average among 72 other Anemia trials with a reported enrollment target (91% lower).

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.

NCT03552393 names 20 study sites across 10 states, led by Other, Alabama, California.

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.

What interventions are being tested in trial NCT03552393?

The interventions under investigation include: Mircera (DRUG).

Who is sponsoring clinical trial NCT03552393?

This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03552393's enrollment target sits among peer trials

40 61st of 72 higher than 11 of 72 other Anemia trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Anemia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03552393, the US trial registry maintained by the National Library of Medicine. NCT03552393 (small enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.