Type 1 Diabetes 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 with diabetes-related kidney disease (DKD) may be eligible if:

• A doctor has diagnosed them with type 1 or type 2 diabetes, confirmed by a blood sugar or HbA1c test, use of diabetes medication, or a formal medical diagnosis code
• They have signs of lasting kidney damage shown on at least two separate medical assessments at least 3 months apart, including reduced kidney filtering ability (eGFR between 30–59) or higher-than-normal levels of protein or albumin in the urine, with the most recent kidney test done within the past year

People with high blood pressure-related kidney disease (H-CKD) may be eligible if:

• A doctor has confirmed a diagnosis of high blood pressure, either through repeated high readings over at least one month, use of blood pressure medication, or a formal medical diagnosis code
• They have signs of lasting kidney damage shown on at least two separate medical assessments at least 3 months apart, including specific ranges of kidney filtering ability and protein/albumin levels in the urine, with the most recent kidney test done within the past year

People with sudden kidney injury (Acute Kidney Injury / AKI) may be eligible if:

• Their baseline kidney filtering ability (eGFR) was above 45, based on recent lab results taken between 7 and 365 days before joining the study
• They also meet at least one of the following: a significant drop in urine output (less than 500 ml in 24 hours); a measurable rise in a specific kidney marker in the blood (creatinine); or a smaller rise in that marker combined with high risk of kidney injury and supporting evidence from urine tests or lab biomarkers (confirm with trial site)

People with type 1 diabetes may be eligible if:

• A doctor and endocrinologist have confirmed a type 1 diabetes diagnosis (not another type), supported by positive antibodies, low levels of a hormone called C-peptide, or a long history of diabetes with complex insulin treatment
• They also have confirmed or early signs of kidney disease, are considered at risk of developing kidney disease based on specific lab or health measures, or have had type 1 diabetes for over 25 years with no signs of kidney damage (a group called "DM-R")

People in the "DM-R" (diabetes-resilient) group may be eligible if:

• They have had type 1 diabetes for more than 25 years
• Their kidneys are still filtering well (eGFR at or above 60)
• Their urine shows very low levels of albumin, suggesting no kidney damage has developed

Who may not be able to join:

• People under 18 years of age
• People who have had a severe allergic reaction to iodinated contrast dye (a substance used in some medical scans)
• People who are pregnant
• People who have received a transplant, including organ or bone marrow transplants
• People who are incarcerated, institutionalised, or otherwise unable to participate
• People who are not able to give informed consent to take part
• People whose kidney disease is caused by an autoimmune condition, a blood protein disorder, a viral illness, or a type of kidney disease other than DKD or H-CKD
• People who are unwilling to receive a blood transfusion if one becomes necessary
• People whose kidney biopsy is considered too risky by their treating doctors or the trial investigators
• People whose kidneys are too deep (more than 13 cm) or too small (less than 8 cm) for a standard biopsy procedure
• People who have only one working kidney
• People with a blocked urinary tract or fluid build-up around the kidneys
• People with many cysts on both kidneys that would make a safe biopsy difficult
• People with an active kidney infection, nearby infection, or a skin infection over the kidney area (for standard biopsy procedures)
• People with any other imaging finding that the doctor believes makes a safe biopsy impossible
• People with certain blood test results that indicate a higher bleeding risk, including abnormal clotting levels, low platelet count, or low haemoglobin
• People on long-term blood-thinning medication
• People who are unable to stop certain blood-thinning or anti-platelet medications (such as aspirin or clopidogrel) for at least 7 days before the biopsy
• People with a blood pressure reading above 160/100 mmHg at the time of the procedure
• People on a ventilator (for standard biopsy procedures)
• People with very low blood pressure or requiring medication to maintain blood pressure (for standard biopsy procedures)
• People with any other condition that the doctor believes makes a safe biopsy impossible

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