NCT05099770Phase 3Active not recruiting

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Study sponsor: Prokidney

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2029-12Estimated

Enrollment · participants685Estimated

Source updated2026-08-11Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Posted 2026-08-11 · 1 field changed

Recruitment status changed

− Before

~~Recruiting~~

+ After

Active not recruiting

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Posted 2026-03-23 · 2 fields changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: Clinical Endpoint

+ After

Measure: Surrogate / Intermediate Efficacy Endpoint -eGFR Slope Measure: Clinical Endpoint

Primary completion date changed

− Before

~~Feb 2027~~

+ After

Dec 2029

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Posted 2026-01-13 · 1 field changed

Main study measure wording changed

Text changed; whether the study measures changed has not been verified. Saved text may be shortened.

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− Before

Measure: ~~Primary Composite~~ Endpoint

+ After

Measure: Clinical Endpoint

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Study details

Conditions studied

Type 2 Diabetes Mellitus; Chronic Kidney Diseases

Treatments or interventions studied

Renal Autologous Cell Therapy (REACT/ rilparencel)Biological

Primary outcomes · main study measures

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measure: Surrogate / Intermediate Efficacy Endpoint -eGFR Slope; description: The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.; timeFrame: 18 months after the 135th participant receives their first injection / sham.; measure: Clinical Endpoint; description: The time from first injection to the earliest of: * At least 40% reduction in eGFR, sustained for 30 days, OR * eGFR \<15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR * Renal or cardiovascular death; timeFrame: From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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