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

Phase 2

Withdrawn

• Conditions: Lupus Nephritis
• Interventions: Drug: Mycophenolate Mofetil

• Registration Number: NCT05101447
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-20
• Study First Submitted QC: 2021-10-20
• Study First Posted: 2021-11-01
• Study Start: 2023-07
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-28
• Last Update Posted: 2023-08-30
• Primary Completion: 2024-01
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MMF PK	Mycophenolate Mofetil	-
MMF BSA	Mycophenolate Mofetil	-

Primary Outcome Measures

Name	Time	Method
renal remission	26 week	defined as at least PRR (CRR or PRR)

Secondary Outcome Measures

Name	Time	Method
Complete Renal Remission	week 26	CRR