The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Conditions

• Lupus Nephritis

Eligibility Criteria

Sex

ALL

Age

8 Years - 20 Years

Healthy Volunteers

Not accepted

Interventions

• Mycophenolate Mofetil — DRUG
  MMF dosed 600mg/m2 body surface area per dose about every 12 hours
• Mycophenolate Mofetil — DRUG
  MMF dosed twice daily to achieve an area under the concentration-time curve (AUC 0-12h) of MPA \>=60-70 mg\*h/L

Study Details

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.

Key Dates

Start date

Jun 7, 2024

Status verified

Mar 2026

Primary completion

Jul 31, 2026

Completion

Jan 31, 2027

Study Design

Enrollment

105 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: MMFBSA
  MMF dosed as per body-surface area
• Experimental: MMFPK
  MMF dosed as per pharmacokinetically-guided precision-dosing

Primary Outcome Measure

To compare the efficacy of MMFPK therapy to the efficacy of MMFBSA therapy [ Time Frame: 26 week ]

Central Contacts

• Angela Sr CRC
  513-803-2118
  [email protected]
• Cat Clinical Research Coordinator
  513-636-7299
  [email protected]

Locations (19)

Find similar trials in San Francisco, CA

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