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Anti-metabolites

MMFPK for Lupus Nephritis (PLUMM Trial)

Q: Are participants currently being recruited for this ongoing clinical trial?

According to the details provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted for recruitment on January 1st, 2024 and underwent its most recent update on January 10th, 2024.

Q: How many individuals are currently enrolled as participants in this clinical trial?

To proceed with the study, a total of 105 eligible participants are required. Genentech, Inc., the sponsor, will oversee the trial across various sites including Hospital for Special Surgery in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a> and Ann &#x26; Robert H. Lurie Children's Hospital of Chicago in Hackensack, <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a>.

Q: What is the level of safety associated with MMFPK when administered to patients?

Based on our assessment, the safety of MMFPK is rated as 2 due to its Phase 2 trial status. While there is limited data supporting its safety, no evidence has been found yet regarding its efficacy.

Q: Is this clinical trial inclusive of individuals who have reached the age of 18?

To be eligible for participation in this study, individuals must fall within the age range of 8 to 18 years old. It is important to note that there are a total of 10 clinical trials available specifically for patients under the age of 18, while there are 42 trials targeting patients over the age of 65.

Q: At how many distinct sites is the management of this study taking place?

This clinical trial is conducted at the Hospital for Special Surgery in Chicago, <a href="https://www.withpower.com/clinical-trials/illinois">Illinois</a>; Ann &#x26; Robert H. Lurie Children's Hospital of Chicago in Hackensack, <a href="https://www.withpower.com/clinical-trials/new-jersey">New jersey</a>; and Hackensack University Medical Center in Chapel Hill, <a href="https://www.withpower.com/clinical-trials/north-carolina">North carolina</a>. Additionally, it is being carried out in seven other locations.

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

PLUMM Trial 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.Check my eligibility

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.See study design

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.

PLUMM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 8 and 17 years old.

Select...

I can swallow pills and capsules.

Select...

I have been diagnosed with lupus according to ACR/EULAR guidelines.

PLUMM Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 26 week

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~26 week

This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 week for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Therapeutic procedure

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

PLUMM 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

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,038 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

485 Previous Clinical Trials

1,086,795 Total Patients Enrolled

2 Trials studying Lupus Nephritis

35 Patients Enrolled for Lupus Nephritis

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,486 Total Patients Enrolled

1 Trials studying Lupus Nephritis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are participants currently being recruited for this ongoing clinical trial?

"According to the details provided on clinicaltrials.gov, this ongoing clinical trial is actively seeking eligible participants. The trial was initially posted for recruitment on January 1st, 2024 and underwent its most recent update on January 10th, 2024."

Answered by AI

How many individuals are currently enrolled as participants in this clinical trial?

"To proceed with the study, a total of 105 eligible participants are required. Genentech, Inc., the sponsor, will oversee the trial across various sites including Hospital for Special Surgery in Chicago, Illinois and Ann & Robert H. Lurie Children's Hospital of Chicago in Hackensack, New jersey."

Answered by AI

What is the level of safety associated with MMFPK when administered to patients?

"Based on our assessment, the safety of MMFPK is rated as 2 due to its Phase 2 trial status. While there is limited data supporting its safety, no evidence has been found yet regarding its efficacy."

Answered by AI

Is this clinical trial inclusive of individuals who have reached the age of 18?

"To be eligible for participation in this study, individuals must fall within the age range of 8 to 18 years old. It is important to note that there are a total of 10 clinical trials available specifically for patients under the age of 18, while there are 42 trials targeting patients over the age of 65."

Answered by AI

At how many distinct sites is the management of this study taking place?

"This clinical trial is conducted at the Hospital for Special Surgery in Chicago, Illinois; Ann & Robert H. Lurie Children's Hospital of Chicago in Hackensack, New jersey; and Hackensack University Medical Center in Chapel Hill, North carolina. Additionally, it is being carried out in seven other locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

Hermine Brunner, MD 2024. "The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05538208.

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