Chronic Kidney Disease, Type 2 Diabetes Mellitus
Conditions
Keywords
Rilparencel
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
Interventions
BIOLOGICALRenal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC).
PROCEDURERenal Biopsy
a procedure in which a small sample of kidney tissue is removed
Sponsors
CTI Clinical Trial and Consulting Services
Prokidney
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Renal Function | Through 24 months following last REACT injection for active arm and at least 12 months following last REACT injection for the deferred arm | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment emergent adverse events | 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 | Treatment emergent adverse events, serial safety laboratory results |
Countries
United States
Outcome results
None listed