A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Inclusion Criteria:

1. The participant is male or female, 30 to 80 years of age on the date of informedconsent.

2. The participant has a clinical diagnosis of T2DM in their health record.

3. The participant has a clinical diagnosis of diabetic nephropathy as the underlyingcause of renal disease (diagnosis does not have to be confirmed via renal biopsy) intheir health record.

4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 9.5% at theScreening Visit.

5. The participant has a documented clinical diagnosis of either: eGFR greater than or equal to 20 and less than 30 mL/min/1.73m², not requiring renaldialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol) OR: eGFR of 30 to lessthan or equal to 35 mL/min/1.73m² AND UACR of 300 to less than or equal to 5000mg/g (33.9 mg/mmol to less than or equal to 565 mg/mmol).

6. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg atScreening (based on the average of 3 measurements obtained while seated) andmaintained during the screening period until randomization.

7. On a clinically relevant and stable dose of an angiotensin converting-enzymeinhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated orcontraindicated.

Exclusion Criteria:

1. The participant has a history of type 1 diabetes mellitus.

2. The participant has a history of renal transplantation or other organtransplantation (corneal transplants are not an exclusion), solitary kidney,recurrent complicated urinary tract infections or complicated kidney stones. Urinarytract infections identified prior to renal biopsy or injection should be resolvedprior to procedures.

3. The participant has any other known underlying cause of kidney disease, includingbut not limited to: Autosomal dominant and recessive polycystic kidney disease,primary focal segmental glomerulosclerosis, vasculitis related CKD, IgA nephropathyand other immune modulated nephropathies, drug-induced CKD or other types of CKD oranatomic variants as determined by the Investigator or Sponsor that would interferewith biopsy and REACT injection procedure or confound study assessments.

4. History of acute kidney injury within 3 months prior to the Screening Visit.

5. Myocardial infarction, unstable angina, revascularization procedure (e.g. stent orbypass graft surgery), or cerebrovascular accident within 12 weeks beforerandomization, or a revascularization procedure is planned during the trial.