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).

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Prokidney
Study ID
NCT04115345
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Renal Autologous Cell Therapy (REACT) — BIOLOGICAL
    Autologous selected renal cells (SRC)

Study Details

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)

Key Dates

First listed
Oct 4, 2019
Start date
Aug 13, 2019
Status verified
Feb 2023
Primary completion
Jan 31, 2023
Completion
Jan 31, 2023

Study Design

Enrollment
6 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: 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 Measure

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]. [ Time Frame: 18 months following last REACT injection ]

Locations (5)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322-
Boise Kidney & Hypertension InstituteMeridianIdaho83642-
Hackensack Meridian Jersey Shore University Medical CenterNeptune CityNew Jersey07753-
Mt. Sinai HospitalNew YorkNew York45246-
University of North Carolina- Chapel HillChapel HillNorth Carolina27599-

Find similar trials in Atlanta, GA

Nationwide
Chronic kidney disease trialsNephrology trialsKidney disease trials
By condition
Chronic kidney disease
By specialty
NephrologyKidney disease
By research site
Emory University Hospital· Atlanta, GABoise Kidney & Hypertension Institute· Meridian, IDHackensack Meridian Jersey Shore University Medical Center· Neptune City, NJMt. Sinai Hospital· New York, NYUniversity of North Carolina- Chapel Hill· Chapel Hill, NC

Related Studies