Clinical trial NCT02836574: A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Type 2 Diabetes Mellitus
Chronic Kidney Disease
Keywords: Rilparencel
Lead sponsor: Prokidney
Sponsor class: INDUSTRY
Collaborators: name: CTI Clinical Trial and Consulting Services
First posted: 2016-07-19
Enrollment: 83
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).

Detailed 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

Eligibility criteria: 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 Type 2 Diabetes Mellitus.
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 Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (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 Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (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 Chronic Kidney Disease (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 Hemoglobin A1c (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 Renal Autologous Cell Therapy (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 Renal Autologous Cell Therapy (REACT) injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.

Primary outcomes:
measure: Change in Renal Function
timeFrame: Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm
Secondary outcomes:
measure: Treatment emergent adverse events
timeFrame: 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
Other outcomes:
Locations:
city: Tucson
country: United States
facility: University of Arizona
state: Arizona
city: Denver
country: United States
facility: Kidney Associates of Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale Univeristy
state: Connecticut
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Meridian
country: United States
facility: Boise Kidney and Hypertension Institute
state: Idaho
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Baton Rouge
country: United States
facility: Renal Associates of Baton Rouge
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Kalamazoo
country: United States
facility: Paragon Health
state: Michigan
city: Tupelo
country: United States
facility: Nephrology & Hypertension Associates
state: Mississippi
city: New York
country: United States
facility: Mt. Sinai Hospital
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina- Chapel Hill
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Health Network
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
city: Madison
country: United States
facility: University of Wisconsin-Madison
state: Wisconsin
Study officials:
affiliation: CTI
name: Brian Johnston
role: STUDY_DIRECTOR
References:
citation: Stavas J, Gerber D, Coca SG, Silva AL, Johns A, Jain D, Bertram T, Diaz-Gonzalez de Ferris M, Bakris G. Novel Renal Autologous Cell Therapy for Type 2 Diabetes Mellitus Chronic Diabetic Kidney Disease: Clinical Trial Design. Am J Nephrol. 2022;53(1):50-58. doi: 10.1159/000520231. Epub 2022 Jan 14.