NCT05101447

Pharmacokinetically-driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Children's Hospital Medical Center, Cincinnati · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

Meta-analyses in adults suggest equivalence of clinical efficacy of intravenous cyclophosphamide and mycophenolate mofetil when dosed based on patient weight or body-surface-area (MMFBSA), as is the current standard for the treatment of proliferative lupus nephritis (LN) treatments in the U.S. Pharmacokinetically-guided precision dosing of MMF (MMFPK) may offer a beneficial modification of the current standard treatment in that MMKPK promises over 30% higher LN response rates than MMFBSA. The objective of the proposed randomized, controlled study is to compare the efficacy and safety of pharmacokinetically-guided precision dosing of MMF (MMFPK) with conventional dosing regimens of MMF (MMFBSA) among children with proliferative LN.

Conditions

• Lupus Nephritis

Interventions

Type	Name	Description
DRUG	Mycophenolate Mofetil	At baseline, subjects will be randomized 1:1 to one of two treatment arms: the current standard of clinical care \[MMFBSA: 600 mg/m2/dose; max: 3 gram/day\] or pharmacokinetically-driven precision dosing \[MMFPK: 12-hour target area under the exposure curve of MPA (MPA-AUC0-12) at 60 mg\*h/L\].

Timeline

• Start date: 2023-07-01
• Primary completion: 2024-01-01
• Completion: 2024-07-01
• First posted: 2021-11-01
• Last updated: 2023-08-30

Regulatory

• FDA-regulated drug study