RECRUITING

The Pediatric Lupus Nephritis Mycophenolate Mofetil (PLUMM) Study

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study is a 1-year 2-part double-blinded placebo controlled 2-arm clinical trial. Treatment arms are (1) MMF dosed as per body-surface area (MMFBSA; 600mg/m2 body surface area per dose about every 12 hours) and (2) pharmacokinetically-guided precision-dosing of MMF (MMFPK; MMF dosed twice daily to achieve an area under the concentration-time curve (AUC0-12h) of MPA \>60-70 mg\*h/L. The study goal is to determine the safety and efficacy of MMFPK compared to MMFBSA for the treatment of proliferative LN in subjects 8 to \<21 years.

Official Title

Efficacy & Safety of Pharmacokinetically-Driven Dosing of Mycophenolate Mofetil for the Treatment of Pediatric Proliferative Lupus Nephritis- a Double-Blind Placebo Controlled Clinical Trial

Quick Facts

Study Start:2024-06-07

Study Completion:2027-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05538208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:8 Years to 20 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
Age 18 years or older Willing and able to provide informed consent Able to understand and follow study procedures Stable medical condition	1. Perceived or stated inability to adhere to the study protocol; 2. Hypersensitivity to MMF or any component of the drug product; 3. Presence of features (from SLE or other chronic disease) that a-priori suggest that the subject benefits from other therapies than that suggested or allowable by the study protocol; These disease features include but are not limited to severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease. 4. History of other kidney disease besides LN or prior to the diagnosis of SLE; 5. Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury. 6. Infections: 1. Untreated latent or active tuberculosis (TB); 2. Chronic infections requiring treatment; 3. A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B; 4. Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit; 5. Any treated infections within 2 weeks of Baseline visit; 6. History of infected joint prosthesis with prosthesis still in situ; 7. Blood dyscrasias, including: 1. Hemoglobin \<8.5 g/dL or Hematocrit \<22%; 2. White Blood Cell count \<2.6 x 109/L; 3. Neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L; 5. Lymphocyte count \<0.5 x 109/L. 8. Estimated glomerular filtration rate \[GFR\] \<40 mL/min/1.73 m2 calculated using the modified Schwartz equation5 (see Appendix 4); 9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal; 10. Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit; 11. History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus \[EBV\] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma); 12. Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ; 13. Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery; 14. Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives). 15. Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit 16. Rituximab or other selective B lymphocyte depleting agents: Must be discontinued for 6 months prior to Baseline visit or CD19/20+ counts must be normal by FACS analysis; 17. Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit 18. Participation in other studies involving investigational drug(s) within 4 weeks or 5 half-lives (whichever is longer) prior to Baseline visit and/or during study participation; Exposure to investigational biologics should be discussed with the Sponsor. 19. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception or are abstinent for the duration of the study; 20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Inclusion Criteria

Exclusion Criteria

Age 18 years or older
Willing and able to provide informed consent
Able to understand and follow study procedures
Stable medical condition

1. Perceived or stated inability to adhere to the study protocol;
2. Hypersensitivity to MMF or any component of the drug product;
3. Presence of features (from SLE or other chronic disease) that a-priori suggest that the subject benefits from other therapies than that suggested or allowable by the study protocol; These disease features include but are not limited to severe, progressive, or uncontrolled hepatic, hematologic, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurologic disease.
4. History of other kidney disease besides LN or prior to the diagnosis of SLE;
5. Need for renal replacement therapy within 2 weeks from Baseline Subjects can have required short-term renal replacement therapy prior to Baseline, for example due to preceding acute kidney injury.
6. Infections:
1. Untreated latent or active tuberculosis (TB);
2. Chronic infections requiring treatment;
3. A subject known to be infected with Human Immunodeficiency Virus (HIV), Hepatitis B;
4. Diagnosis of any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within 4 weeks prior to Baseline visit;
5. Any treated infections within 2 weeks of Baseline visit;
6. History of infected joint prosthesis with prosthesis still in situ;
7. Blood dyscrasias, including:
1. Hemoglobin \<8.5 g/dL or Hematocrit \<22%;
2. White Blood Cell count \<2.6 x 109/L;
3. Neutrophil count \<1.2 x 109/L;
4. Platelet count \<100 x 109/L;
5. Lymphocyte count \<0.5 x 109/L.
8. Estimated glomerular filtration rate \[GFR\] \<40 mL/min/1.73 m2 calculated using the modified Schwartz equation5 (see Appendix 4);
9. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>1.5 times the upper limit of normal;
10. Vaccinated or exposed to a live or attenuated vaccine within the 4 weeks prior to Baseline visit;
11. History or current symptoms suggestive of lymphoproliferative disorders (e.g., Epstein Barr Virus \[EBV\] related lymphoproliferative disorder, lymphoma, leukemia, myeloproliferative disorders, or multiple myeloma);
12. Current malignancy or history of any malignancy with the exception of adequate treated or excised basal cell or squamous cell or cervical cancer in situ;
13. Recent (within 4 weeks prior to Baseline visit) significant trauma or major surgery;
14. Herbal supplements with pharmaceutical properties must be discontinued at least 1week prior to Baseline visit, unless there are sufficient data available regarding the duration of an herbal medication's pharmacokinetic and pharmacodynamic effects to allow a shorter or longer washout to be specified (e.g., 5 half-lives).
15. Oral or intravenous cyclophosphamide must be discontinued 12 weeks prior to Baseline visit
16. Rituximab or other selective B lymphocyte depleting agents: Must be discontinued for 6 months prior to Baseline visit or CD19/20+ counts must be normal by FACS analysis;
17. Use of prohibited prescription medication as listed in Appendix 3 within the specified time frame prior to Baseline visit
18. Participation in other studies involving investigational drug(s) within 4 weeks or 5 half-lives (whichever is longer) prior to Baseline visit and/or during study participation; Exposure to investigational biologics should be discussed with the Sponsor.
19. Pregnant female subjects; breastfeeding female subjects; male subjects with partners currently pregnant; male subjects able to father children and female subjects of childbearing potential who are unwilling or unable to use two highly effective methods of contraception or are abstinent for the duration of the study;
20. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study.

Contacts and Locations

Study Contact

Angela Sr CRC

CONTACT

513-803-2118

plumm@cchmc.org

Cat Clinical Research Coordinator

CONTACT

513-636-7299

Catherine.Robben@cchmc.org

Principal Investigator

Hermine I Brunner, MD

PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

University of California, San Francisco

San Francisco, California, 94518

United States

Children's Hospital Colorado

Aurora, Colorado, 80045

United States

Emory Children's Center

Atlanta, Georgia, 30322

United States

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60614

United States

University of Chicago Medicine- Comer Children's

Chicago, Illinois, 60637

United States

Washington University in St. Louis School of Medicine

St. Louis, Missouri, 63110

United States

Hackensack University Medical Center

Hackensack, New Jersey, 07601

United States

Hospital for Special Surgery

New York, New York, 10021

United States

Children's Hospital at Montefiore

New York, New York, 10467

United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599

United States

Akron Children's Hospital

Akron, Ohio, 44307

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45223

United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Nationwide Children's Hospital

Columbus, Ohio, 43205

United States

Medical University of South Carolina

Charleston, South Carolina, 29425

United States

Baylor College of Medicine Pediatric Immunology Allergy Rheumatology

Houston, Texas, 77030

United States

University of Utah

Salt Lake City, Utah, 84132

United States

Seattle Children's Hospital/University of Washington

Seattle, Washington, 98105

United States

Children's Wisconsin/Medical College of Wisconsin

Milwaukee, Wisconsin, 53226

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Hermine I Brunner, MD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-07

Study Completion Date2027-01

Study Record Updates

Study Start Date2024-06-07

Study Completion Date2027-01

Terms related to this study

Additional Relevant MeSH Terms

Lupus Nephritis