A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

NCT ID: NCT03270956

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-25
• Study Completion Date: 2022-11-17

Brief Summary

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

Detailed Description

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Renal Autologous Cell Therapy (REACT)

Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.

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. The subject is male or female, 30 to 65 years of age on the date of informed consent.

2. The subject has an established diagnosis of T2DM.

3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.

4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.

5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.

6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.

Exclusion Criteria

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

2. The subject has a history of renal transplantation.

3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.

4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).

5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CTI Clinical Trial and Consulting Services

OTHER

Sponsor Role: collaborator

Prokidney

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashley Johns

Role: STUDY_DIRECTOR

Prokidney

Locations

University of Arizona [WITHDRAWN]

Tucson, Arizona, United States

Boise Kidney & Hypertension Institute

Boise, Idaho, United States

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, United States

Vanderbilt University [WITHDRAWN]

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

REGEN-003

Identifier Type: -

Identifier Source: org_study_id