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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: Recruiting Phase 2 study of Lupus Nephritis, sponsored by Children's Hospital Medical Center, Cincinnati.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
the percentage of subjects achieving at least partial remission of LN (PRR) as per the adapted ACR/EULAR Criteria at Week 26
Conditions Studied
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
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2024-06-07 |
| Est. Completion | 2027-01 |
| Phase | Phase 2 |
What NCT05538208 shows while recruiting
NCT05538208 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 307-participant average among 30 other Lupus Nephritis trials with a reported enrollment target (66% lower).
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 lists 19 locations in 14 states (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.
Learn More About Clinical Trials
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Where NCT05538208's enrollment target sits among peer trials
105 13th of 30 higher than 18 of 30 other Lupus Nephritis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Lupus Nephritis 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.
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