Chronic Kidney Disease, Type 2 Diabetes Mellitus
Conditions
Brief summary
The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).
Detailed description
All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.
Interventions
BIOLOGICALRenal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Sponsors
CTI Clinical Trial and Consulting Services
Prokidney
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Open label
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. The subject is male or female, 30 to 65 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 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection. 5. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure. 6. A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Procedure and/or Product Related Adverse Events | Through 24 months following last REACT injection | Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Renal Specific Adverse Events | Through 24 months following last REACT injection | Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Renal Autologous Cell Therapy (REACT) Renal Autologous Cell Therapy (REACT) Treatment - Patients will receive their first treatment of 2 injections of REACT as soon as REACT product is made available.
Renal Autologous Cell Therapy (REACT): Autologous selected renal cells (SRC) | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Renal Autologous Cell Therapy (REACT) |
|---|---|
| Age, Continuous | 58.3 years STANDARD_DEVIATION 5.03 |
| BMI (kg/m^2) at Screening, | 35.20 kg/m^2 STANDARD_DEVIATION 8.415 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Sex: Female, Male Female | 5 Participants |
| Sex: Female, Male Male | 5 Participants |
| Volume (cm^3) - Treated kidney | 180.97 cm^3 STANDARD_DEVIATION 76.077 |
| Volume (cm^3) - Untreated kidney | 163.93 cm^3 STANDARD_DEVIATION 35.279 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 10 |
| other Total, other adverse events | 10 / 10 |
| serious Total, serious adverse events | 8 / 10 |
Outcome results
Primary
Procedure and/or Product Related Adverse Events
Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term
Time frame: Through 24 months following last REACT injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | All Body Systems | 70.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | Renal and urinary disorders | 60.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | renal haematoma | 30.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | subcapsular renal hematoma | 20.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | haematuria | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | perinephric collection | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | Blood and lymphatic system disorder | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | anaemia | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | General disorders and administration site conditions | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | fatigue | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | Injury, poisoning, and procedural complications | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Procedure and/or Product Related Adverse Events | procedural pain | 10.0 percent of participants |
Secondary
Renal Specific Adverse Events
Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term
Time frame: Through 24 months following last REACT injection
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Acute Kidney Disease | 30.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Chronic Kidney Disease | 20.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Renal and urinary disorders | 90.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | End Stage Renal Disease | 50.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Renal haematoma | 40.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Subcapsular renal haematoma | 20.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Haematuria | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | Hydronephrosis | 10.0 percent of participants |
| Renal Autologous Cell Therapy (REACT) | Renal Specific Adverse Events | perinephric collection | 10.0 percent of participants |