Renal Autologous Cell Therapy for Chronic Kidney Disease

Phase-Based Progress Estimates
2
Effectiveness
3
Safety
Chronic Kidney Disease+1 MoreRenal Autologous Cell Therapy - Biological
Eligibility
30 - 80
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new way to treat diabetes and kidney disease by injecting a medication into the kidneys. The goal is to see if it is safe and effective.

Eligible Conditions
  • Chronic Kidney Disease
  • Type 2 Diabetes

Treatment Effectiveness

Effectiveness Progress

2 of 3
This is further along than 85% of similar trials

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: up to 60 Months

up to 60 Months
Primary Composite Endpoint
Secondary Composite Endpoint

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Cohort 2
1 of 2
Cohort 1
1 of 2

Experimental Treatment

Non-Treatment Group

600 Total Participants · 2 Treatment Groups

Primary Treatment: Renal Autologous Cell Therapy · Has Placebo Group · Phase 3

Cohort 2Experimental Group · 4 Interventions: Renal Autologous Cell Therapy (REACT), Renal Autologous Cell Therapy (REACT™), Renal Autologous Cell Therapy, Renal Autologous Cell Therapy (REACT®) · Intervention Types: Biological, Biological, Biological, Biological
Cohort 1ShamComparator Group · 4 Interventions: Renal Autologous Cell Therapy (REACT), Renal Autologous Cell Therapy (REACT™), Renal Autologous Cell Therapy, Renal Autologous Cell Therapy (REACT®) · Intervention Types: Biological, Biological, Biological, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Renal Autologous Cell Therapy (REACT)
2018
Completed Phase 2
~10
Renal Autologous Cell Therapy (REACT™)
2018
Completed Phase 2
~10
Renal Autologous Cell Therapy (REACT®)
2018
Completed Phase 2
~10

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: up to 60 months

Who is running the clinical trial?

ProkidneyLead Sponsor
6 Previous Clinical Trials
750 Total Patients Enrolled
PPDIndustry Sponsor
148 Previous Clinical Trials
30,942 Total Patients Enrolled
Iqvia Pty LtdIndustry Sponsor
93 Previous Clinical Trials
232,068 Total Patients Enrolled
Ashley JohnsStudy DirectorSVP Clinical Operations, ProKidney
5 Previous Clinical Trials
749 Total Patients Enrolled

Eligibility Criteria

Age 30 - 80 · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a diagnosis of diabetic nephropathy in your health record.
You have a documented eGFR of greater than or equal to 20 and less than or equal to 50 mL/min/1.73m².
You have a HbA1c less than 10% at the Screening Visit.