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

NCT ID: NCT05101447

Last Updated: 2023-08-30

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2024-07-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MMF PK

Group Type: EXPERIMENTAL

Mycophenolate Mofetil

Intervention Type: DRUG

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 \[MMFPK: 12-hour target area under the exposure curve of MPA (MPA-AUC0-12) at 60 mg\*h/L\].

MMF BSA

Group Type: ACTIVE_COMPARATOR

Mycophenolate Mofetil

Intervention Type: DRUG

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 \[MMFPK: 12-hour target area under the exposure curve of MPA (MPA-AUC0-12) at 60 mg\*h/L\].

Interventions

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 \[MMFPK: 12-hour target area under the exposure curve of MPA (MPA-AUC0-12) at 60 mg\*h/L\].

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

New diagnosis with proliferative LN based on kidney biopsy done within 4 weeks of enrollment Diagnosis with childhood-onset SLE (cSLE) as per the ACR criteria95, 96 Age 8 - 17 years at the time of enrollment96 Tolerates oral MMF

Exclusion Criteria

Perceived or stated inability to adhere to study protocol, Lack of use of highly effective birth control method. Presence of cSLE features that a-priori suggest that the patient benefits from other therapy than that suggested by the study protocol, History of significant kidney disease prior to the diagnosis with cSLE, Need for renal replacement therapy at the time of enrolment, Concurrent therapy with CYC or rituximab.

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Hermine Brunner, MD

Director, Division of Rheumatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

PRUNE

Identifier Type: -

Identifier Source: org_study_id