A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

NCT05286853 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: REGEN-016
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Type 2 Diabetes Mellitus; Chronic Kidney Diseases

Keywords

REACT; Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Primary Composite Endpoint

  The time from first injection to the earliest of: * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or * eGFR \<15 mL/min/1.73m² using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or * Renal or cardiovascular death

  up to 60 Months post last injection of the investigational product or the last simulated injection.

Secondary Outcomes (2)

• First Secondary Endpoint: Time to progression of Chronic Kidney Disease

  up to 60 Months post last injection of the investigational product or the last simulated injection

• Second Secondary Endpoint: Time to End Stage Renal Disease

  up to 60 Months post last injection of the investigational product or the last simulated injection

Study Arms (2)

Sham Procedure

SHAM COMPARATOR

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

Procedure: Sham Comparator

Experimental (REACT injections)

EXPERIMENTAL

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

Biological: Renal Autologous Cell Therapy (REACT)

Interventions

Renal Autologous Cell Therapy (REACT) BIOLOGICAL

Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection.

Experimental (REACT injections)

Sham Comparator PROCEDURE

Participants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection.

Sham Procedure

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The participant is male or female, 30 to 80 years of age on the date of informed consent.
• The participant has a clinical diagnosis of T2DM in their health record.
• 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.
• The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
• The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis.
• The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g.

You may not qualify if:

• The participant has a history of type 1 diabetes mellitus.
• The participant has a history of renal transplantation.
• The participant 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, across 3 measurements while seated.
• The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Sponsors & Collaborators

• Prokidney: lead

Study Sites (3)

IMIM Hospital del Mar Medical Research Institute

Barcelona, 08003, Spain

Location

Hospital Universitario Vall D'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28026, Spain

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

Study Officials

• Study Director

  Prokidney

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: March 18, 2022
• Study Start: July 17, 2024
• Primary Completion: September 3, 2024
• Study Completion: September 3, 2024
• Last Updated: September 25, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

ES (3)