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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

A Phase 2 Prospective, Randomized, Double-Arm, Deferred Treatment, Open Label, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02836574
• Other study ID #: RMCL-002
• Status: Completed
• Phase: Phase 2
• Start date: September 2016
• Est. completion date: December 2023

Study information

• Verified date: February 2024
• Source: Prokidney
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with T2DM and CKD.

Description:

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria for Study Part 1:

1. The subject is male or female, 30 to 80 years of age on the date of informed consent.

2. The subject has an established diagnosis of T2DM.

3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.

4. The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 20 and 50 mL/min/1.73m².

5. The subject has blood pressure less than 150/90 at the Screening Visit.

6. The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.

7. A minimum of 2 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of CKD.

Exclusion Criteria for Study Part 1:

1. The subject has a history of type 1 diabetes mellitus.

2. The subject has a history of renal transplantation.

3. The subject has a serum HbA1c level greater than 10% at the Screening Visit.

4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).

5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Inclusion Criteria for Study Part 2:

1. The subject is willing and able to provide signed informed consent.

2. The subject was enrolled into Part 1 of the study and received at least one REACT injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Lehigh Valley Health Network	Allentown	Pennsylvania
United States	University of Michigan	Ann Arbor	Michigan
United States	Renal Associates of Baton Rouge	Baton Rouge	Louisiana
United States	University of North Carolina- Chapel Hill	Chapel Hill	North Carolina
United States	University of Chicago Medical Center	Chicago	Illinois
United States	Kidney Associates of Colorado	Denver	Colorado
United States	University of Florida	Gainesville	Florida
United States	Paragon Health	Kalamazoo	Michigan
United States	University of Louisville	Louisville	Kentucky
United States	University of Wisconsin-Madison	Madison	Wisconsin
United States	Boise Kidney and Hypertension Institute	Meridian	Idaho
United States	Vanderbilt University	Nashville	Tennessee
United States	Yale Univeristy	New Haven	Connecticut
United States	Mt. Sinai Hospital	New York	New York
United States	University of Arizona	Tucson	Arizona
United States	Nephrology & Hypertension Associates	Tupelo	Mississippi

Sponsors (2)

Lead Sponsor	Collaborator
Prokidney	CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Renal Function	Serial measurements of estimated glomerular filtration rate (eGFR) obtained pre-randomization and at three-month intervals through 24 months after the last REACT injection in the active treatment group and at least 12 months post last REACT injection in the deferred treatment group.	Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
Secondary	Treatment emergent adverse events	Treatment emergent adverse events, serial safety laboratory results	Through 24 months following last REACT injection for the active arm and at least 12 months following the last REACT injection for the deferred arm