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NCT05018416
Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Phase 2 trial testing Renal Autologous Cell Therapy (REACT) in Chronic Kidney Diseases in 53 participants. Completed in 20 May 2025.
20 May 2025
Quick facts
| Lead sponsor | Prokidney |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 53 |
| Start date | 27 July 2021 |
| Primary completion | 20 May 2025 |
| Estimated completion | 20 May 2025 |
| Sites | 5 locations across United States |
Drugs / interventions tested
- Renal Autologous Cell Therapy (REACT) — full drug profile →
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →
- Type 2 Diabetes Mellitus — all drugs for Type 2 Diabetes Mellitus →
Sponsor
Prokidney — full company profile →
Who can join
Adults 30 to 80, any sex, with Chronic Kidney Diseases or Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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).
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
-
Spotlight on Genetic Kidney Diseases: A Call for Drug Delivery and Nanomedicine Solutions.
Trac N, Ashraf A, Giblin J, Prakash S, et al · · 2023 · cited 26× · PMID 36988207 · DOI 10.1021/acsnano.2c12140 -
Cell therapy in kidney diseases: advancing treatments for renal regeneration.
Salybekov AA, Kinzhebay A, Kobayashi S. · · 2024 · cited 5× · PMID 39723242 · DOI 10.3389/fcell.2024.1505601 -
Rilparencel (Renal Autologous Cell Therapy-REACT®) for Chronic Kidney Disease and Type 1 and Type 2 Diabetes: Phase 2 Trial Design Evaluating Bilateral Kidney Dosing and Redosing Triggers.
Stavas J, Silva AL, Wooldridge TD, Aqeel A, et al · · 2024 · cited 3× · PMID 38423000 · DOI 10.1159/000537942 -
A Randomized Clinical Trial of Kidney Autologous Cell Therapy in Diabetic Kidney Disease.
Čižman B, Butler EL, Stavas J, Prakash R, et al · · 2026 · cited 2× · PMID 41481370 · DOI 10.2215/cjn.0000000969 -
Novel Therapeutic Strategies for Patients With CKD and Diabetes Mellitus.
Kugathasan L, Katz A, Muskiet MHA, Sridhar VS, et al · · 2026 · PMID 42205183 · DOI 10.1016/j.ekir.2026.106547
Verify or expand the search:
- PubMed search for NCT05018416
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Renal Autologous Cell Therapy (REACT)
Trials testing the same drug.
- NCT05286853 — A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease · Phase 3 · withdrawn
- NCT06790498 — Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product · enrolling by invitation
- NCT05694169 — A Study of Participants With Chronic Kidney Disease Previously Treated With REACT · Phase 1 · terminated
- NCT04115345 — A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomali · Phase 1 · completed
- NCT03270956 — A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease · Phase 2 · completed
Other recruiting trials for Chronic Kidney Diseases
Currently open trials in the same condition.
- NCT06593392 — Safety and Tolerability of Difelikefalin in Adolescents on Haemodialysis With Moderate-to-Severe Pruritus · Phase 2 · recruiting
- NCT07358572 — Eye-Brain-Kidney in CKD · recruiting
- NCT06463483 — Automated Insulin Delivery in Adults With Advanced Kidney Disease · NA · recruiting
- NCT06927024 — Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) in Chronic Kidney Disease (CKD) · NA · recruiting
- NCT07115953 — Streamlined Denervation With spYral For an Optimized Treatment (SPYRAL SWYFT) in Subjects With Uncontrolled Hypertension · NA · recruiting
Other Prokidney trials
Trials by the same sponsor.
- NCT05286853 — A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease · Phase 3 · withdrawn
- NCT06790498 — Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product · enrolling by invitation
- NCT05694169 — A Study of Participants With Chronic Kidney Disease Previously Treated With REACT · Phase 1 · terminated
- NCT04115345 — A Study of a Renal Autologous Cell Therapy (REACT) in Patients With Chronic Kidney Disease (CKD) From Congenital Anomali · Phase 1 · completed
- NCT03270956 — A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05018416 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Prokidney
- Last refreshed: 13 March 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05018416.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing