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

Phase 3

Recruiting

• Conditions: Type 2 Diabetes Mellitus; Chronic Kidney Diseases
• Interventions: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Sham Comparator

• Registration Number: NCT05286853
• Lead Sponsor: Prokidney

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.

Detailed 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 for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-18
• Status Verified: 2024-07
• Study Start: 2024-07-17
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-26
• Primary Completion: 2028-04
• Study Completion: 2028-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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 10% at the Screening Visit.
5. 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.
6. 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.

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Exclusion Criteria

1. The participant has a history of type 1 diabetes mellitus.
2. The participant has a history of renal transplantation.
3. 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.
4. 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental (REACT injections)	Renal Autologous Cell Therapy (REACT)	Participants randomized to the experimental arm will receive 2 injections of REACT.
Sham Procedure	Sham Comparator	Participants randomized to the Sham Comparator arm will have 2 sham procedures

Primary Outcome Measures

Name	Time	Method
Primary Composite Endpoint	up to 60 Months post last injection of the investigational product or the last simulated injection.	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

Secondary Outcome Measures

Name	Time	Method
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	Time to progression of Chronic Kidney Disease; * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or; * eGFR \<15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or or; * Renal death
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	Time to End Stage Renal Disease; * eGFR, \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days. and/or chronic dialysis, and/or renal transplant or; * Renal death.

Trial Locations

Locations (3)

IMIM Hospital del Mar Medical Research Institute; 🇪🇸 Barcelona, Spain

Hospital Universitario Vall D'Hebron; 🇪🇸 Barcelona, Spain

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain