Gender
All
Age Group
30 Years to 80 Years
Accepting Healthy Volunteers
No
Inclusion Criteria:
1. The participant is male or female, 30 to 80 years of age on the date of informed
consent.
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 underlying
cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in
their health record.
4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 9.5% at the
Screening 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 renal
dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol) OR: eGFR of 30 to less
than 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 at
Screening (based on the average of 3 measurements obtained while seated) and
maintained during the screening period until randomization.
7. On a clinically relevant and stable dose of an angiotensin converting-enzyme
inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or
contraindicated.
Exclusion Criteria:
1. The participant has a history of type 1 diabetes mellitus.
2. The participant has a history of renal transplantation or other organ
transplantation (corneal transplants are not an exclusion), solitary kidney,
recurrent complicated urinary tract infections or complicated kidney stones. Urinary
tract infections identified prior to renal biopsy or injection should be resolved
prior to procedures.
3. The participant has any other known underlying cause of kidney disease, including
but not limited to: Autosomal dominant and recessive polycystic kidney disease,
primary focal segmental glomerulosclerosis, vasculitis related CKD, IgA nephropathy
and other immune modulated nephropathies, drug-induced CKD or other types of CKD or
anatomic variants as determined by the Investigator or Sponsor that would interfere
with 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 or
bypass graft surgery), or cerebrovascular accident within 12 weeks before
randomization, or a revascularization procedure is planned during the trial.