Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05018416
• Other study ID #: REGEN-007
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: July 27, 2021
• Est. completion date: September 22, 2026

Study information

• Verified date: May 2023
• Source: Prokidney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Description:

The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

• Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up

• Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection).

Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53
• Est. completion date: September 22, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.

2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.

3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).

4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.

5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria:

1. The subject has a history of renal transplantation.

2. The subject 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.

Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.

3. The subject has hemoglobin levels 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 1
• Diabetes Mellitus, Type 2
• Kidney Diseases
• Renal Insufficiency, Chronic
• Type 1 Diabetes Mellitus
• Type 2 Diabetes Mellitus

Intervention

Biological:
• Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

Locations

Country	Name	City	State
United States	Kidney Associates of Colorado, P.C. - Frenova	Denver	Colorado
United States	Paragon Health, PC d/b/a Nephrology Center, PC - Frenova	Kalamazoo	Michigan
United States	Boise Kidney and Hypertension Institute - Frenova	Nampa	Idaho
United States	Nephrology Associates	Newark	Delaware
United States	Nephrology and Hypertension Associates Ltd - Frenova	Tupelo	Mississippi

Sponsors (1)

Lead Sponsor	Collaborator
Prokidney

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation		Screening thru month 28
Primary	Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.		Screening thru 18 months after the last injection of study drug