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NCT05099770 · ClinicalTrials.gov registry record · Phase 3
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
A Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Diseases, sponsored by Prokidney.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 685
- Enrollment target
- 20
- Study locations
NCT05099770: Recruiting Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Diseases, sponsored by Prokidney.
NCT05099770 is a Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Diseases that is actively recruiting participants, run by Prokidney. The registered enrollment target is 685 participants, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05099770, a Phase 3 study of Type 2 Diabetes Mellitus and Chronic Kidney Diseases, is actively recruiting participants, sponsored by Prokidney.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 685 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.
Primary Outcome
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.
Conditions Studied
Interventions
- PROCEDURE Sham Comparator
- BIOLOGICAL Renal Autologous Cell Therapy (REACT/ rilparencel)
Study Locations (20)
California
- Amicis Research Center - Beverly Hills
- Paradise Clinical Research Group LLC - Glendora
- Kidney Consultants Medical Group - Granada Hills
- IMD Clinical Trials - Huntington Park
- Advanced Medical Research, LLC - Lakewood
- Medicine and Nephrology Associates - Los Alamitos
- Academic Medical Research Institute - Los Angeles
- Southern California Hospital - Los Angeles
- Allameh Medical Corporation - Mission Viejo
- Golden Pacific Nephrology Medical Clinic Inc - Monterey Park
- Northridge Kidney Care Center - Northridge
- Valley Renal Medical Group - Northridge
- Valley Clinical Trials - Northridge
- Integrity Medical Discovery - Pico Rivera
- National Institute of Clinical Research - Pomona
- Nephrology Associates Medical Group - Riverside
- UC Davis Medical Group GI Unit - Sacramento
- North America Research Institute - San Dimas
Alabama
- Nephrology Consultants - Huntsville
Arizona
- University of Arizona - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 685 participants |
| Start Date | 2022-01-05 |
| Est. Completion | 2029-12 |
| Phase | Phase 3 |
What NCT05099770 shows while recruiting
NCT05099770 is an interventional study that assigns participants to a tested intervention. The registered 685 participants enrollment target is mid-sized for trials with a published cap, below the 2,955-participant average among 130 other Type 2 Diabetes Mellitus trials with a reported enrollment target (77% lower).
The record links to 2 conditions, with Type 2 Diabetes Mellitus appearing as the primary indexed condition, and to 2 interventions - of which Sham Comparator is the first listed.
NCT05099770 names 20 study sites across 3 states, led by California, Alabama, Arizona.
Frequently Asked Questions
What is clinical trial NCT05099770 about?
NCT05099770 is a clinical study titled "Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease". The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.
What is the current status of trial NCT05099770?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 685 participants. The study started on 2022-01-05. Estimated completion is 2029-12.
What conditions does trial NCT05099770 study?
This clinical trial studies the following conditions: Type 2 Diabetes Mellitus, Chronic Kidney Diseases.
What interventions are being tested in trial NCT05099770?
The interventions under investigation include: Sham Comparator (PROCEDURE), Renal Autologous Cell Therapy (REACT/ rilparencel) (BIOLOGICAL).
Who is sponsoring clinical trial NCT05099770?
This trial is sponsored by Prokidney, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05099770 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Type 2 Diabetes Mellitus
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05099770's enrollment target sits among peer trials
685 16th of 130 higher than 115 of 130 other Type 2 Diabetes Mellitus trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Type 2 Diabetes Mellitus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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