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

NCT03270956 | Completed Phase 2 Results FDA Drug

• 1 other identifier: REGEN-003
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 4

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).

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Procedure and/or Product Related Adverse Events

  Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term

  Through 24 months following last REACT injection

Secondary Outcomes (1)

• Renal Specific Adverse Events

  Through 24 months following last REACT injection

Study Arms (1)

Renal Autologous Cell Therapy (REACT)

EXPERIMENTAL

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.

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

Autologous selected renal cells (SRC)

Renal Autologous Cell Therapy (REACT)

Eligibility Criteria

• Age: 30 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The subject is male or female, 30 to 65 years of age on the date of informed consent.
• The subject has an established diagnosis of T2DM.
• The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
• 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.
• 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.
• 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.

You may not qualify if:

• The subject has a history of type 1 diabetes mellitus.
• The subject has a history of renal transplantation.
• The subject has a serum HbA1c level greater than 10% at the Screening Visit.
• The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
• The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Sponsors & Collaborators

• Prokidney: lead
• CTI Clinical Trial and Consulting Services: collaborator

Study Sites (4)

University of Arizona [WITHDRAWN]

Tucson, Arizona, 85724, United States

Location

Boise Kidney & Hypertension Institute

Boise, Idaho, 83642, United States

Location

University of North Carolina- Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Vanderbilt University [WITHDRAWN]

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: to be determined
• Organization: ProKidney

info@prokidney.com

n/a

Study Officials

• Ashley Johns

  Prokidney

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Masking Details: Open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2017
• First Posted: September 1, 2017
• Study Start: April 25, 2018
• Primary Completion: November 17, 2022
• Study Completion: November 17, 2022
• Last Updated: March 24, 2025
• Results First Posted: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)