Long-term follow-up for patients who received REACT injections for kidney disease
A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004
This study is looking at how safe and effective REACT injections are for people with chronic kidney disease over a five-year period.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 30 Years to 80 Years |
| Sex | All |
| Sponsor | Prokidney Industry-sponsored |
| Locations | 1 site (Meridian, Idaho) |
| Trial ID | NCT05918523 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the long-term safety and effects of gelatin-hydrogel formulation REACT injections on renal function in participants with chronic kidney disease (CKD). Up to 80 participants who previously received REACT in earlier clinical trials will be monitored over a period of five years through a combination of in-clinic and phone visits. The study focuses on evaluating the outcomes of these injections administered 3 to 6 months apart, specifically looking at their impact on kidney health.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals who have previously received REACT injections in earlier trials for chronic kidney disease.
Not a fit: Patients who have not received REACT in prior studies will not benefit from this follow-up study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of REACT injections for managing chronic kidney disease.
How similar studies have performed: While this study builds on previous trials involving REACT, it focuses on long-term follow-up, which may provide new insights into its safety and efficacy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol. Exclusion Criteria: * The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
Where this trial is running
Meridian, Idaho
- Boise Kidney & Hypertension Institute — Meridian, Idaho, United States (Recruiting)
Study contacts
- Study coordinator: Beth Hilburger
- Email: info@prokidney.com
- Phone: 336-999-7031
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.