Phase 3 Chronic Kidney Disease 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 male or female, between 30 and 80 years of age at the time of signing consent
• People who have been diagnosed with both type 2 diabetes and chronic kidney disease
• People whose HbA1c blood sugar level measure is 9.5% or lower at the screening visit
• People whose blood pressure at screening is no higher than 140 (top number) and 90 (bottom number)
• People for whom a type of diabetes medication called an SGLT2 inhibitor has been strongly considered by their doctor
• People who are already taking a blood pressure medication known as an ACE inhibitor or an ARB, at the highest dose they are able to tolerate, unless their doctor has determined these are not suitable for them
• People who are able and willing to avoid medications that increase bleeding risk during specified time periods before and after a procedure
• People who are willing and able to follow all parts of the study plan and sign a consent form

Who may not be able to join:

• People who have a history of type 1 diabetes
• People who have had a kidney transplant or any other organ transplant
• People whose kidney disease is caused by something other than type 2 diabetes
• People who have had a sudden kidney injury or major surgery in the 3 months before screening
• People who have had a heart attack, unstable chest pain, a procedure to restore blood flow to the heart or brain, or a stroke within 12 weeks before being enrolled, or who have such a procedure planned during the trial
• People who have the most severe category of heart failure (classified as NYHA Class IV)
• People who have had certain types of cancer within the past 3 years before screening (confirm with trial site for which cancers apply)
• People with significant liver disease, including active or chronic hepatitis B or hepatitis C
• People with a known HIV infection, active syphilis, an unresolved active infection of the urinary or genital tract, or active tuberculosis needing treatment at the time of screening
• People with a weakened immune system, or who have been taking medications that suppress the immune system — including treatment for chronic kidney inflammation — within 3 months of signing consent
• People who have had a recent bleeding event, have a known bleeding disorder, or are at increased risk of blood clots or bleeding
• People whose kidney imaging shows reasons why a biopsy or the study injection (rilparencel) cannot safely be performed
• People who are currently taking blood-thinning (anticoagulant) medications
• People who have had a severe allergic or whole-body reaction to blood transfusions, a substance called Dextran 40, or products derived from cattle, or who have a medical or personal reason to avoid these products
• People who have had a severe reaction to local anaesthetics or sedatives, or who have a reason they cannot receive these
• People who have taken part in another clinical trial or used an investigational product within 12 weeks before enrolment, or who have previously received the study treatment rilparencel
• People whose overall health condition, in the treating doctor's judgement, would be put at risk by taking part in the study

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