Phase 4 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:

• People aged 18 to 80 years who have signed a consent form and are able to follow the study plan, in the trial doctor's judgment
• People who have been formally diagnosed with Systemic Lupus Erythematosus (SLE, a disease where the immune system attacks the body) based on recognised medical criteria, with at least one specific positive blood test result in the last 3 years
• People who have a specific type of kidney disease caused by lupus (called Lupus Nephritis, classes III, IV, III/V, or IV/V), confirmed by a kidney biopsy — whether newly diagnosed, currently being treated, or having come back after previous treatment
• People whose urine protein test (a measure of kidney leakage) shows a result above 750 mg/gm from a 24-hour urine collection during the screening period
• People whose resting blood pressure is below 150/90 mmHg at screening (this can be re-checked during the screening period if the first reading is higher)
• People who have been on the maximum tolerated dose of a specific type of blood pressure and kidney-protecting medication (ACE inhibitor or ARB) for at least 4 weeks before joining, or who have a documented intolerance to these medications
• People taking other specific blood pressure or kidney-protecting medications, provided the dose has been stable for at least 4 weeks before joining
• People whose kidney function test (eGFR) meets specific minimum levels depending on when their kidney biopsy was taken and what it showed (confirm with trial site for the exact requirements that apply)
• People whose blood counts meet minimum levels: enough white blood cells (neutrophils and lymphocytes), platelets above a certain level, and haemoglobin above 8.5 g/dL
• People who are either already taking a medication called Belimumab before the study starts, or who are able to begin taking it at the start of the study
• People who are able to use a highly effective method of contraception consistently throughout the study, if there is any possibility of becoming pregnant — accepted methods include hormonal contraception, an IUD, tubal ligation, a vasectomised partner (as sole partner), or complete abstinence from intercourse that could result in pregnancy (note: people taking MMF or MPA medications must also use an additional barrier method if on oral contraception)

Who may not be able to join:

• People who are currently on dialysis, have had dialysis in the last 3 months, have had a kidney transplant, or are expected to need dialysis within the next 6 months
• People who have received the chemotherapy drug cyclophosphamide within 12 weeks before starting the study drug
• People who have received certain immune-system medications — including Rituximab or Obinutuzumab within 24 weeks of screening (unless a specific B-cell blood count is above 10%), or certain other B-cell-targeting treatments within 12 weeks of screening
• People who have received certain other immune-modifying or anti-inflammatory medications (including abatacept, adalimumab, infliximab, tocilizumab, anifrolumab, and several others) within 12 weeks of screening
• People whose kidney biopsy shows a specific type of lupus nephritis called "Pure Class V"
• People who, in the trial doctor's opinion, do not need long-term immune-suppressing treatment beyond steroids alone
• People with a known allergy or medical reason to avoid any of the study medications, including MMF, MPA, cyclosporine, tacrolimus, voclosporin, corticosteroids, or belimumab
• People who have had pancreatitis or serious gastrointestinal bleeding within the last 6 months, or an active, unhealed stomach ulcer within the last 3 months
• People who have a confirmed HIV infection
• People who, in the trial doctor's opinion, have had a clinically significant problem with drug or alcohol use in the last 2 years
• People with a known cancer diagnosed within the last 5 years (certain treated skin cancers and treated cervical changes may be exceptions — confirm with trial site)
• People with a history of lymph node cancer or previous radiation treatment to the lymph system
• People with a known active hepatitis B or C infection within 3 months of screening (people with past exposure may be eligible if a specific DNA blood test is negative — confirm with trial site)
• People with active tuberculosis (TB), or a history of TB without currently taking a preventive antibiotic called isoniazid — a specific TB blood test must be negative at screening, or the person must be taking isoniazid
• People with certain serious heart conditions, including severe heart failure, a history of abnormal heart rhythms, a specific inherited heart electrical condition, or a particular abnormal result on a heart tracing (ECG) — confirm details with trial site
• People whose liver function blood tests show results more than 2.5 times above the normal range at screening

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