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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).

Phase 1
Completed
Conditions
Chronic Kidney Disease
Congenital 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
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).
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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.
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
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
NameTimeMethod
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
NameTimeMethod
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

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