A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomalies of the Kidney and Urinary Tract (CAKUT).
- Conditions
- Chronic Kidney DiseaseCongenital Anomalies of Kidney and Urinary Tract
- Interventions
- Biological: Renal Autologous Cell Therapy (REACT)
- Registration Number
- NCT04115345
- Lead Sponsor
- Prokidney
- Brief Summary
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)
- Detailed Description
It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- The patient is male or female, 18 to 65 years of age on the date of informed consent.
- The patient has a documented history of a corrected abnormality of the kidney and/or urinary tract (CAKUT) leading to renal dysfunction.
- The patient has an established diagnosis of Stage III/IV CKD not requiring renal dialysis.
- The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s).
- The patient has a history of renal transplantation.
- The patient has a diagnosis of hydronephrosis, SFU Grade 4 or 5.
- The patient has an uncorrected VUR Grade 5.
- The patient has a diffuse cortical thickness throughout the kidney measuring < 5 mm on MRI that prevents safe cortical biopsy.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Renal Autologous Cell Therapy (REACT) Renal Autologous Cell Therapy (REACT) The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.
- Primary Outcome Measures
Name Time Method 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]. 18 months following last REACT injection 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.
- Secondary Outcome Measures
Name Time Method Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT). 18 months following last REACT injection 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.
Trial Locations
- Locations (5)
Hackensack Meridian Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Mt. Sinai Hospital
🇺🇸New York, New York, United States
University of North Carolina- Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Boise Kidney & Hypertension Institute
🇺🇸Meridian, Idaho, United States