Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open-Label, Repeat Dose, Safety and Efficacy Study of Autologous Neo-Kidney Augment (NKA) in Subjects with Type 2 Diabetes and Chronic Kidney Disease
ID Number 16-2403Principal Investigator(s)
Steven G Coca
Department(s) or Division(s)
The purpose of this study is to investigate the safety and tolerability of Autologous Neo-Kidney Augment (NKA) for treating chronic kidney disease (CKD).
Subjects may qualify to take part in this research study because they are type 2 diabetic and have CKD and the study doctor thinks they are suitable for the study.
Subjects will be screened and undergo a series of tests to determine if they are eligible for the study. Subjects will then undergo a kidney biopsy to extract a sample of selected renal cells (SRC) to prepare the NKA solution.
After the biopsy, subjects will be randomized in a 1:1 ratio into either the Active Treatment or Deferred treatment group. This means there is a 50% chance of being in the Active group, and 50% chance of being in the deferred group. The Active Treatment group will receive the first NKA injection soon after the biopsy (about one month), and the second injection 3 months after the first. The Deferred treatment group will receive the first NKA injection 12-18 months after the biopsy and the second injection 3 months after the first. Both groups will also undergo a 12 month follow-up period after the NKA injections.
Participation in this research study is expected to last 13-16 months for the Active Treatment group and 24-27 months for the Deferred Treatment group.
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is approximately 50 subjects in approximately 15 study centers across the United States.
Recruiting Patients: Yes