NCT04115345

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).

Completed Phase 1 Last updated 21 December 2023

What this trial tests

Phase 1 trial testing Renal Autologous Cell Therapy (REACT) in Chronic Kidney Disease in 6 participants. Completed in 31 January 2023.

Timeline

13 August 2019

Primary endpoint
31 January 2023

31 January 2023

Quick facts

Lead sponsor	Prokidney
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	6
Start date	13 August 2019
Primary completion	31 January 2023
Estimated completion	31 January 2023
Sites	5 locations across United States

Drugs / interventions tested

• Renal Autologous Cell Therapy (REACT) — full drug profile →

Conditions studied

• Chronic Kidney Disease — all drugs for Chronic Kidney Disease →
• Congenital Anomalies of Kidney and Urinary Tract — all drugs for Congenital Anomalies of Kidney and Urinary Tract →

Sponsor

Prokidney — full company profile →

Who can join

Adults 18 to 65, any sex, with Chronic Kidney Disease or Congenital Anomalies of Kidney and Urinary Tract. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Translational Applications of Hydrogels.
   Correa S, Grosskopf AK, Lopez Hernandez H, Chan D, et al · · 2021 · cited 575× · PMID 33938724 · DOI 10.1021/acs.chemrev.0c01177
2. Hydrogels in the clinic.
   Mandal A, Clegg JR, Anselmo AC, Mitragotri S. · · 2020 · cited 265× · PMID 32440563 · DOI 10.1002/btm2.10158
3. Current and Future Prospective of Injectable Hydrogels-Design Challenges and Limitations.
   Almawash S, Osman SK, Mustafa G, El Hamd MA. · · 2022 · cited 96× · PMID 35337169 · DOI 10.3390/ph15030371
4. Biomedical Application, Patent Repository, Clinical Trial and Regulatory Updates on Hydrogel: An Extensive Review.
   Mohapatra S, Mirza MA, Hilles AR, Zakir F, et al · · 2021 · cited 50× · PMID 34842705 · DOI 10.3390/gels7040207
5. 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
6. Protocol and Baseline Data on Renal Autologous Cell Therapy Injection in Adults with Chronic Kidney Disease Secondary to Congenital Anomalies of the Kidney and Urinary Tract.
   Stavas J, Diaz-Gonzalez de Ferris M, Johns A, Jain D, et al · · 2021 · cited 8× · PMID 33647913 · DOI 10.1159/000512586
7. 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
8. Hydrogel Films in Biomedical Applications: Fabrication, Properties and Therapeutic Potential.
   Sutradhar SC, Shin H, Kim W, Jang H. · · 2025 · PMID 41294603 · DOI 10.3390/gels11110918