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Anti-metabolites
Mycophenolate Mofetil for Pediatric Lupus Nephritis (PLUMM Trial)
Phase 2
Recruiting
Led By Hermine I Brunner, MD
Research Sponsored by Children's Hospital Medical Center, Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female aged 8 to < 18 years;
Able to swallow MMF tablets and capsules;
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 week
Awards & highlights
No Placebo-Only Group
Summary
This trial is a 1-year study with two parts. It is double-blinded, meaning neither the participants nor the researchers know which treatment they are receiving. The trial is comparing two different treatment approaches
Who is the study for?
This trial is for kids aged 8 to under 18 with a specific kidney condition called proliferative lupus nephritis. They must meet certain criteria for systemic lupus erythematosus, have a recent kidney biopsy confirming the diagnosis, and be able to take mycophenolate mofetil (MMF) tablets.
What is being tested?
The PLUMM study tests two ways of dosing MMF in children with lupus nephritis: one based on body surface area and another tailored to individual drug levels in the blood. The goal is to see which method is safer and more effective over a year.
What are the potential side effects?
Possible side effects of MMF include stomach upset, increased risk of infections due to weakened immune system, lower blood cell counts which can lead to anemia or bleeding problems, and potential liver issues.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 8 and 17 years old.
Select...
I can swallow pills and capsules.
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I have been diagnosed with lupus according to ACR/EULAR guidelines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 26 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 week
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Therapeutic procedure
Side effects data
From 2014 Phase 3 trial • 87 Patients • NCT0007547823%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: MMFPKExperimental Treatment1 Intervention
MMF dosed as per pharmacokinetically-guided precision-dosing
Group II: MMFBSAActive Control1 Intervention
MMF dosed as per body-surface area
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
Genentech, Inc.Industry Sponsor
1,558 Previous Clinical Trials
569,331 Total Patients Enrolled
4 Trials studying Lupus Nephritis
565 Patients Enrolled for Lupus Nephritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
496 Previous Clinical Trials
1,089,407 Total Patients Enrolled
2 Trials studying Lupus Nephritis
35 Patients Enrolled for Lupus Nephritis
Children's Hospital Medical Center, CincinnatiLead Sponsor
834 Previous Clinical Trials
6,564,884 Total Patients Enrolled
1 Trials studying Lupus Nephritis
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