Phase 4 Vasculitis 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 who are able to give written consent before any study assessments begin
• Adults aged 18 to 65 years, of any sex
• People who have been diagnosed with primary IgA nephropathy (a kidney condition), confirmed by a kidney biopsy — the timing requirements for how recent the biopsy must be depend on kidney function and whether the person has diabetes (confirm with trial site)
• People whose kidney function (measured by a calculation called eGFR) is at least 20 mL/min/1.73 m² at the screening visit
• People who have a significant amount of protein in their urine, measured over a 24-hour urine collection, meeting specific thresholds (confirm with trial site)
• People who have been taking the maximum tolerated dose of a blood pressure medication called an ACE inhibitor or ARB, plus a specific diabetes/kidney medication called Dapagliflozin 10mg daily, for at least 12 weeks before and up to the study start date
• People whose blood pressure is at or below 140/90 mmHg at the time of randomisation
• Women who are not pregnant and who agree to avoid becoming pregnant for the duration of the study

Who may not be able to join:

• People whose IgA nephropathy is caused by another condition, such as liver cirrhosis, lupus, or certain skin or joint conditions (a related condition called IgA vasculitis may still be eligible in some circumstances — confirm with trial site)
• People showing signs of nephrotic syndrome at screening, based on specific blood and urine test results (confirm with trial site)
• People whose kidney function has declined very rapidly — by 50% or more — in the three months before screening
• People whose kidney biopsy shows an additional kidney disease alongside IgA nephropathy
• Women who are planning to become pregnant
• People with certain ongoing health conditions, including systemic autoimmune diseases, active long-term infections such as tuberculosis, hepatitis B, hepatitis C, or HIV, chronic liver disease, or chronic obstructive pulmonary disease
• People who have had a kidney or other organ transplant in the past, or who are expected to need one during the study (corneal transplants are an exception)
• People with a BMI of 40 or above at the screening visit
• People with poorly controlled diabetes, defined by a specific blood test result (HbA1c above 8%) at screening
• People with a history or diagnosis of a demyelinating condition such as multiple sclerosis or optic neuritis
• People who have recently taken certain medications, including oral steroids for more than two weeks (within the past 12 weeks), immunosuppressant drugs, certain biologic therapies, traditional or Ayurvedic medicines, or other specific medications within defined time periods before screening (confirm with trial site for full details)
• People with a history of unstable chest pain, severe heart failure (Class III or IV), or significant heart rhythm problems, as assessed by the study doctor
• People with an active significant infection, or who have been hospitalised for infection or received intravenous antibiotics within four weeks before or during the screening visit
• People with a history of cancer in the past five years (some skin cancers that have been fully treated and have not returned may be exceptions — confirm with trial site)
• People with a known allergy or sensitivity to any of the study medications
• People who have had major surgery within six weeks before the screening visit
• People with a significant history of alcohol or drug misuse in the year before the screening visit, as determined by the study doctor
• People who are unwilling or unable to follow all study procedures

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