CompletedPhase 2

Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)

United States53 participantsStarted 2021-07-27

Plain-language summary

The purpose of this study is to assess the safety, efficacy, and durability of up to two Renal Autologous Cell Therapy (REACT) / rilparencel injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with Type1 Diabetes Mellitus (T1DM) or Type2 Diabetes Mellitus(T2DM) and Chronic Kidney Disease (CKD).

Who can participate

Age range30 Years – 80 Years

SexALL

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Inclusion criteria

✓. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
✓. Clinical diagnosis of Type1 Diabetes Mellitus or Type2 Diabetes Mellitus, controlled per institutional standard of care.
✓. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
✓. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
✓. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion criteria

✕. The subject has a history of renal transplantation.
✕. The subject has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening.
✕. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for Chronic Kidney Disease-related anemia prior to randomization.

What they're measuring

Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation

Timeframe: Screening thru month 28

Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.

Timeframe: Screening thru 18 months after the last injection of study drug

Trial details

NCT IDNCT05018416

SponsorProkidney

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-05-20

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