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NCT05018416 (Renal Autologous Cell Therapy in Type 1 or 2 Diabetes and…): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 10 Jun 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically probably insignificant and commercially probably insufficient.

Clinical Trial

NCTID
NCT05018416
Acronym
REGEN-007
Drug Name
Renal Autologous Cell Therapy
Drug MoA
renal autologous kidney progenitor cell therapy
Drug Modality
Cell Therapy
Drug Class
First-In-Class
Therapeutic Area
Nutritional and Metabolic Diseases and Urogenital Diseases
Indication
Type 1 or 2 Diabetes and Chronic Kidney Disease
Human Patients
53
Sponsor
ProKidney
Phase
Phase 2

Prediction of , index 647

Prospective Prediction
Prediction Index
647
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
117 days in advance
Readout Data Interpretation
average eGFR change from baseline to 18 months was -1.3 ml/min/1.73m2 (given no-zero placebo average eGFR change; the placebo-adjusted eGFR change of REACT would probably be smaller than the SoC Empagliflozin (DOI- 10.1056/NEJMoa2204233).
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically probably insignificant and commercially probably insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Phase
Phase 2
Status
Completed
Enrollment
53
Lead sponsor
Prokidney
Conditions
Chronic Kidney Diseases; Type 1 Diabetes Mellitus; Type 2 Diabetes Mellitus
Interventions
BIOLOGICAL: Renal Autologous Cell Therapy (REACT)
Design
Randomized · Parallel · None
Primary purpose
Treatment
Start
2021-07-27
Primary completion
2025-05-20
Completion
2025-05-20
Primary outcomes
  • 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 (Screening thru month 28)
  • Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection. (Screening thru 18 months after the last injection of study drug)

NCT05018416 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials