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

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05101447

Acronym

PRUNE

Enrollment

Registered

2021-11-01

Start date

2023-07-31

Completion date

2024-07-31

Last updated

2023-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lupus Nephritis

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.

Interventions

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
renal remission	26 week	defined as at least PRR (CRR or PRR)

Secondary

Measure	Time frame	Description
Complete Renal Remission	week 26	CRR

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026