Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 8 and 20 years old (male or female)
• You have been diagnosed with Systemic Lupus Erythematosus (SLE, sometimes called "lupus") according to standard medical guidelines
• You have been diagnosed with a specific type of kidney disease related to lupus (called lupus nephritis), confirmed by a kidney biopsy taken within the last 90 days, and the biopsy showed a specific class of disease (Class 3, 3/5, 4, or 4/5)
• You are being treated with a medication called MMF (mycophenolate mofetil), taken twice a day, and have taken it for at least 4 days as prescribed by your doctor
• Your doctor believes you are tolerating MMF well
• You are able to swallow tablets and capsules
• If you are taking a medication called belimumab, it must be given by IV or injection under the skin
• You are willing and able to attend scheduled visits, follow the study plan, and complete required tests and procedures
• You (and your parent or legal guardian) have read and signed the consent forms agreeing to take part
• Your parent or legal guardian has a smartphone that can run the study's app (called PLUMM)
• You are able to complete study questionnaires in English or Spanish

Who may not be able to join:

• You or your guardian feel you would not be able to follow the study plan
• You have had an allergic reaction to MMF or any of its ingredients
• You have serious, uncontrolled disease affecting the liver, blood, digestive system, metabolism, hormones, lungs, heart, or nervous system (confirm with trial site)
• You have a kidney disease other than lupus nephritis, or had kidney disease before your lupus diagnosis
• You need ongoing kidney replacement therapy (such as dialysis) within 2 weeks of starting the study
• You have untreated tuberculosis (TB), active TB, or ongoing infections that need treatment
• You are known to have HIV or Hepatitis B
• You had an infection requiring hospital care or IV antibiotics within the last 4 weeks
• You had any treated infection within the last 2 weeks
• You have an artificial joint that has previously been infected and is still in your body
• Your blood test results show certain blood count levels that are too low (including red blood cells, white blood cells, platelets, or other blood cell types) (confirm with trial site)
• Your kidney function is below a certain level, based on a specific calculation used for children and young adults (confirm with trial site)
• Your liver enzyme levels (AST or ALT) are significantly above the normal range
• You received a live or weakened vaccine, or were exposed to one, within the last 4 weeks
• You have a history of, or current signs of, certain blood or lymph system cancers (such as lymphoma or leukemia)
• You currently have cancer, or have had cancer in the past (with some exceptions for certain treated skin or cervical cancers — confirm with trial site)
• You have had a major injury or surgery within the last 4 weeks
• You are taking herbal supplements with drug-like effects and have not stopped them at least 1 week before starting the study
• You took a medication called cyclophosphamide within the last 12 weeks
• You are taking certain other prescription medications that are not allowed in this study (confirm with trial site for the full list)
• You have taken part in another clinical trial involving an experimental drug within the last 4 weeks or 5 half-lives of that drug (whichever is longer)
• You are pregnant, breastfeeding, or are a male whose partner is currently pregnant
• You are able to have children but are unwilling or unable to use two effective methods of birth control (or abstinence) for the duration of the study
• You have another serious medical or mental health condition, or abnormal lab results, that the study doctor believes would make participation unsafe or affect the study results

Important: Always verify eligibility with the trial site directly before applying.