Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

NCT ID: NCT05018416

Last Updated: 2025-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-27
• Study Completion Date: 2025-05-20

Brief Summary

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Detailed Description

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

• Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up
• Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection).

Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Conditions

Chronic Kidney Diseases; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

2 REACT injections

Cohort 1 subjects will receive 2 REACT injections in the biopsied and non-biopsied contralateral kidneys 3 months apart (+60 days).

Group Type: EXPERIMENTAL

Renal Autologous Cell Therapy (REACT)

Intervention Type: BIOLOGICAL

Autologous selected renal cells (SRC)

1 REACT Injection

Cohort 2 subjects will receive 1 REACT injection into the biopsied kidney and if a pre-defined trigger is met, will undergo a second REACT injection into the contralateral kidney.

Group Type: EXPERIMENTAL

Renal Autologous Cell Therapy (REACT)

Intervention Type: BIOLOGICAL

Autologous selected renal cells (SRC)

Interventions

Renal Autologous Cell Therapy (REACT)

Autologous selected renal cells (SRC)

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.

2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.

3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).

4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.

5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria

1. The subject has a history of renal transplantation.

2. The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.

Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

3. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Prokidney

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Catherine Taylor

Role: STUDY_DIRECTOR

Prokidney

Locations

Kidney Associates of Colorado, P.C. - Frenova

Denver, Colorado, United States

Nephrology Associates

Newark, Delaware, United States

Boise Kidney and Hypertension Institute - Frenova

Nampa, Idaho, United States

Paragon Health, PC d/b/a Nephrology Center, PC - Frenova

Kalamazoo, Michigan, United States

Nephrology and Hypertension Associates Ltd - Frenova

Tupelo, Mississippi, United States

Countries

United States

Other Identifiers

REGEN-007

Identifier Type: -

Identifier Source: org_study_id