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NCT05538208 · ClinicalTrials.gov registry record · Phase 2

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

A Phase 2 study of Lupus Nephritis, sponsored by Children's Hospital Medical Center, Cincinnati.

Recruiting
Registry status
Phase 2
Development phase
105
Enrollment target
19
Study locations

NCT05538208 is a Phase 2 study of Lupus Nephritis that is actively recruiting participants, run by Children's Hospital Medical Center, Cincinnati. The registered enrollment target is 105 participants, below the 307-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (66% lower). The trial reports 19 study locations across 14 states.

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The verdict

NCT05538208, a Phase 2 study of Lupus Nephritis, is actively recruiting participants, sponsored by Children's Hospital Medical Center, Cincinnati.

RECRUITING
Registry status
Phase 2
Development phase
105 participants
Enrollment target
19
Study locations

Study Summary

The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA \>60-70 mg\*h/L. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to \<21 years.

Conditions Studied

Lupus Nephritis

Interventions

  • DRUG Mycophenolate Mofetil

Study Locations (19)

Ohio

  • Akron Children's Hospital - Akron
  • Cincinnati Children's Hospital Medical Center - Cincinnati
  • University Hospitals Cleveland Medical Center - Cleveland
  • Nationwide Children's Hospital - Columbus

Illinois

  • Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
  • University of Chicago Medicine- Comer Children's - Chicago

New York

  • Hospital for Special Surgery - New York
  • Children's Hospital at Montefiore - New York

California

  • University of California, San Francisco - San Francisco

Colorado

  • Children's Hospital Colorado - Aurora

Georgia

  • Emory Children's Center - Atlanta

Missouri

  • Washington University in St. Louis School of Medicine - St Louis

New Jersey

  • Hackensack University Medical Center - Hackensack

Trial Details

FieldValue
Enrollment Target 105 participants
Start Date 2024-06-07
Est. Completion 2027-01
Phase Phase 2

Sponsor

Children's Hospital Medical Center, Cincinnati

571 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05538208

The ClinicalTrials.gov registry entry for NCT05538208 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 307-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (66% lower). The listed sponsor is Children's Hospital Medical Center, Cincinnati, which has 571 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Lupus Nephritis appearing as the primary indexed condition, and to 1 intervention - of which Mycophenolate Mofetil is the first listed.

NCT05538208 reports 19 study locations spanning 14 distinct geographic areas - top geographies include Ohio, Illinois, New York.

Frequently Asked Questions

What is clinical trial NCT05538208 about?

NCT05538208 is a clinical study titled "The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study". The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily t...

What is the current status of trial NCT05538208?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 105 participants. The study started on 2024-06-07. Estimated completion is 2027-01.

What conditions does trial NCT05538208 study?

This clinical trial studies the following conditions: Lupus Nephritis.

What interventions are being tested in trial NCT05538208?

The interventions under investigation include: Mycophenolate Mofetil (DRUG).

Who is sponsoring clinical trial NCT05538208?

This trial is sponsored by Children's Hospital Medical Center, Cincinnati, which has 571 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05538208 being conducted?

This trial has 19 study locations across California, Colorado, Georgia, Illinois, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.