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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05286853
• Other study ID #: REGEN-016
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: July 2024
• Est. completion date: April 2028

Study information

• Verified date: December 2023
• Source: Prokidney
• Contact: Patricia Guillen
• Phone: 1-802-310-9473
• Email: patricia.guillen[@]iqvia.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 600
• Est. completion date: April 2028
• Est. primary completion date: April 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 2 Diabetes Mellitus

Intervention

Biological:
• Renal Autologous Cell Therapy (REACT)
Participants will receive either 2 REACT injections or 2 Sham REACT injections into biopsied and non-biopsied contralateral kidneys 3 months apart.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Prokidney	Iqvia Pty Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First Secondary Endpoint: Time to progression of Chronic Kidney Disease	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	up to 60 Months post last injection of the investigational product or the last simulated injection
Secondary	Second Secondary Endpoint: Time to End Stage Renal Disease	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.	up to 60 Months post last injection of the investigational product or the last simulated injection