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CKD patients previously treated with REACT for Chronic Kidney Disease

N/A
Recruiting
Research Sponsored by Prokidney
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 60 months from completion of parent protocol eos visit
Awards & highlights

Study Summary

The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).

Eligible Conditions
  • Chronic Kidney Disease
  • Diabetic Kidney Disease

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months from completion of parent protocol eos visit
This trial's timeline: 3 weeks for screening, Varies for treatment, and 60 months from completion of parent protocol eos visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Primary Endpoint: Long-term safety of REACT
Secondary outcome measures
First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²
Second Secondary Endpoint: Time from first injection to chronic dialysis.
Third Secondary Endpoint: Time from first injection to renal transplant.

Trial Design

1Treatment groups
Experimental Treatment
Group I: CKD patients previously treated with REACTExperimental Treatment1 Intervention
Participants Exposed to Renal Autologous Cell Therapy from studies RMCL-002, REGEN-003, REGEN-004 (REGEN-008S1).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Autologous Cell Therapy (REACT)
2016
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

ProkidneyLead Sponsor
8 Previous Clinical Trials
1,363 Total Patients Enrolled
Study DirectorStudy DirectorProkidney
1,209 Previous Clinical Trials
489,384 Total Patients Enrolled
Ashley Johns, MSHSStudy DirectorProkidney
2 Previous Clinical Trials
11 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Long-Term Follow-Up Study of Participants Exposed to REACT
2023. "A Long-Term Follow-Up Study of Participants Exposed to REACT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05918523.
All > Meridian
~53 spots leftby Jan 2028
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