Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05538208 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Study acronym: PLUMM
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 5 months later Jul 2026 → Jan 2027
See other at-risk trials from Children's Hospital Medical Center, Cincinnati

Record History

  1. Primary completion pushed from Jul 2026 to Jan 2027v10
  2. Site contacts updated at 6 of 19 sitesv9
  3. Eligibility criteria shortened, about 31 words Site contacts updated at 19 of 19 sitesv8 Show 1 more changeShow less
    • Site contacts updated at 19 of 19 sites

    See this version in full on ClinicalTrials.gov ↗

  4. Primary completion date: Jul 2025 to Jul 2026 Completion date: Mar 2026 to Jan 2027 · Site details revised at 2 of 19 sitesv7 Show 2 more changesShow less
    • Completion date: Mar 2026 to Jan 2027
    • Site details revised at 2 of 19 sites
  5. Study sites: 7 to 19 Eligibility criteria shortened, about 22 words · Collaborators reorderedv6 Show 2 more changesShow less
    • Eligibility criteria shortened, about 22 words
    • Collaborators reordered

    See this version in full on ClinicalTrials.gov ↗

Show 4 earlier versionsHide 4 earlier versions
  1. Start date changed from estimate of Jan 2024 to Jun 7, 2024v5
  2. Trial status: Not Yet Recruiting to Recruiting Start date: Aug 2023 to Jan 2024 · Study sites: 0 to 7v4 Show 2 more changesShow less
    • Start date: Aug 2023 to Jan 2024
    • Study sites: 0 to 7
  3. Start date: Jul 2023 to Aug 2023v3
  4. Start date: Jan 2023 to Jul 2023 Primary completion date: Sep 2025 to Jul 2025 · Eligibility criteria shortened, about 34 wordsv2 Show 2 more changesShow less
    • Primary completion date: Sep 2025 to Jul 2025
    • Eligibility criteria shortened, about 34 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05538208
Lead Sponsor Children's Hospital Medical Center, Cincinnati
Collaborators: Genentech, Inc., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Conditions Lupus Nephritis
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov