This phase 2 trial aims to compare the safety and effectiveness of receiving Neo-Kidney Augment™ (NKA) using two different approaches following diagnosis with chronic kidney disease (CKD)
The main outcome to be investigated is kidney function by measuring glomerular filtration rate (eGFR) 12 months following NKA treatment.
The details
Patients with diabetes are at an increased risk of developing chronic kidney disease (CKD). In CKD, kidney cells die and the function of the organ becomes poorer. Neo-Kidney Augment™ (NKA) is a treatment that involves harvesting a patient’s kidney cells and growing them to great numbers in a laboratory. The cells are packaged in a gel that is then suitable for injection into the patient’s kidney.
NKA injection may improve kidney function by regenerating healthy kidney tissue from these injected kidney cells. This study will investigate if NKA injection immediately following CKD diagnosis is more beneficial than NKA injection following 12 months of standard CKD therapy. The main outcome will be to assess if NKA has any effect on kidney function.
Who are they looking for?
This study will recruit approximately 50 patients (aged 30-80 years) with type 2 diabetes and CKD. The cause of CKD must be due diabetic nephropathy. Patients should have stable blood pressure below 140/90 mmHg but not significantly lower than 115/70 mmHg.
Patients cannot take part in the trial if they have had a kidney transplant or have uncontrolled diabetes (HbA1c level greater than 10%). Other exclusion criteria include: abnormal blood clotting status, history of bleeding disorders, cancer, liver, lung or heart disease, known allergies to certain antibiotics, and infections. Pregnant women or those planning to become pregant are not suitable for this trial.
How will it work
Patients will be randomly assigned to 2 groups. Patients in the active treatment group will received 1 NKA injection as soon as the product is manufactured. 12 weeks later, patients will be assessed and receive a second injection of NKA. Patients in the deferred treatment group will receive standard treatment for CKD and undergo regular follow-up every 12 weeks for a maximum of 12-18 months. At this point, these patients will receive an injection of NKA and a second injection 12 weeks later.
Kidney function will be assessed by measuring a number of parameters including glomerular filtration rate (eGFR). Patients will also be asked to complete a survey to measure their health-related quality of life. The study will end 12 months following the last injection of NKA.
