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A Long-Term Follow-Up Study of Participants Exposed to REACT
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
No Placebo-Only Group
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 belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 60 months from completion of parent protocol eos visit
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~60 months from completion of parent protocol eos visit
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Endpoint: Long-term safety of REACT
Secondary study objectives
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.
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
763 Total Patients Enrolled
Study DirectorStudy DirectorProkidney
1,281 Previous Clinical Trials
500,422 Total Patients Enrolled
Ashley Johns, MSHSStudy DirectorProkidney
2 Previous Clinical Trials
11 Total Patients Enrolled