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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04115345
Other study ID # REGEN-004
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date August 13, 2019
Est. completion date January 31, 2023

Study information

Verified date February 2023
Source Prokidney
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)


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 information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Prokidney CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

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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