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

Prokidney

Status and phase: Enrolling; Phase 3

Conditions: Chronic Kidney Diseases; Type 2 Diabetes Mellitus

Treatments: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Sham Comparator

Study type: Interventional

Funder types: Industry

Identifiers

NCT05099770

REGEN-006

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.

Full description

Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.

Enrollment: 685 estimated patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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685 participants in 2 patient groups

Sham Procedure

Sham Comparator group

Description:

Participants randomized to the Sham Comparator arm will have 2 sham procedures.

Treatment:

Procedure: Sham Comparator

Experimental (REACT injections)

Experimental group

Description:

Participants randomized to the experimental arm will receive 2 injections of REACT.

Treatment:

Biological: Renal Autologous Cell Therapy (REACT)