Phase 1 Chronic Kidney Disease Trial, Recruiting

Written by an AI model from the 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 have given written consent and are willing and able to follow all study requirements.
• People aged 18 or older at the time of giving written consent.
• People who have been diagnosed with end-stage kidney disease (kidney failure) and have been receiving regular dialysis for at least 12 weeks before the screening appointment.

Who may not be able to join:

• People who are currently taking medicines that suppress the immune system, have a primary immune system disorder, have active tuberculosis (TB), have a history of latent (inactive) TB without completing a full course of preventive treatment, show signs of HIV infection, test positive for hepatitis B or C, have a significant active infection, have a history of or currently have invasive fungal infections, other serious opportunistic infections, or recurring skin infections (two or more episodes in the year before screening), have received a live vaccine within 6 weeks before screening, have a urinary catheter in place, or have wet gangrene or non-healing wounds.
• People with certain abnormal blood test results, including abnormal liver function, low white blood cell count, low platelet count, or significant anaemia.
• People with a life-threatening illness (other than heart or blood vessel disease) expected to cause death within 12 months, active liver disease or significant liver impairment, an unplanned hospital stay within 30 days before screening, major surgery within the past 3 months or planned major surgery known at the time of screening, poorly controlled high blood pressure, a current or past (within 5 years) cancer diagnosis (with limited exceptions for certain fully removed or non-recurring skin or cervical cancers), active or recent serious bleeding (within 30 days), a kidney transplant scheduled within 6 months of screening, a known allergy or severe reaction to CSL300 or its ingredients, or a history of demyelinating disorders (conditions affecting the protective coating of nerves).
• People with a history of a hole or tear in the gut (gastrointestinal perforation), inflammatory bowel disease (except fully removed ulcerative colitis), peptic ulcer disease within the past 12 months, a history of diverticular disease or diverticulitis (except if fully surgically removed), Crohn's disease, or prior gastric bypass surgery. People with a finding of small pouches in the gut (diverticulosis) but no history of symptoms or treatment may be considered at the investigator's discretion.
• People showing signs of inadequate dialysis, those unwilling or unable to follow study procedures, those with a history of not following medical treatments, or those with ongoing alcohol or substance misuse.
• People who have taken part in another research study involving an experimental treatment within 3 months before screening.
• People who are pregnant, breastfeeding, or unwilling to use adequate contraception during the study and for 5 months after the last dose of the study drug.
• People for whom the study investigator believes participation would put their safety at risk, affect the quality of the data, or whose life expectancy is less than one year.
• People whom the study sponsor determines are no longer needed for the study.

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