CompletedPhase 1

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).

United States6 participantsStarted 2019-08-13

Plain-language 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)

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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).

Exclusion criteria

✕. 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.

What they're measuring

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].

Timeframe: 18 months following last REACT injection

Trial details

NCT IDNCT04115345

SponsorProkidney

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-01-31

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