A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

July 17, 2024

Primary Completion Date

September 3, 2024

Study Completion Date

September 3, 2024

Conditions
Type 2 Diabetes MellitusChronic Kidney Diseases
Interventions
BIOLOGICAL

Renal Autologous Cell Therapy (REACT)

Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection.

PROCEDURE

Sham Comparator

Participants receiving institutional standard of care will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection.

Trial Locations (3)

28026

Hospital Universitario 12 de Octubre, Madrid

08003

IMIM Hospital del Mar Medical Research Institute, Barcelona

08035

Hospital Universitario Vall D'Hebron, Barcelona

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Prokidney

INDUSTRY

NCT05286853 - A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease | Biotech Hunter | Biotech Hunter