Chronic Kidney Disease Clinical Trial
Official title:
A Phase 1 Open-Label Safety, Tolerability, and Early Efficacy Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
Verified date | February 2023 |
Source | Prokidney |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
Status | Completed |
Enrollment | 6 |
Est. completion date | January 31, 2023 |
Est. primary completion date | January 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: 1. The patient is male or female, 18 to 65 years of age on the date of informed consent. 2. The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction. 3. The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis. 4. The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Exclusion Criteria: 1. The patient has a history of renal transplantation. 2. The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5. 3. The patient has an uncorrected VUR Grade 5. 4. The patient has a diffuse cortical thickness throughout the kidney measuring < 5 mm on MRI that prevents safe cortical biopsy. |
Country | Name | City | State |
---|---|---|---|
United States | Emory University Hospital | Atlanta | Georgia |
United States | University of North Carolina- Chapel Hill | Chapel Hill | North Carolina |
United States | Boise Kidney & Hypertension Institute | Meridian | Idaho |
United States | Hackensack Meridian Jersey Shore University Medical Center | Neptune | New Jersey |
United States | Mt. Sinai Hospital | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Prokidney | CTI Clinical Trial and Consulting Services |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety]. | The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 18 months post-treatment. | 18 months following last REACT injection | |
Secondary | Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT). | The number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT) will be observed utilizing renal-specific laboratory assessments. | 18 months following last REACT injection |
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