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ProKidney, LLC

ProKidney, LLC logo
🇺🇸United States
Ownership
-
Employees
-
Market Cap
$1.8B
Website

Clinical Trials

12

Active:2
Completed:4

Trial Phases

3 Phases

Phase 1:4
Phase 2:4
Phase 3:2

Drug Approvals

0

Drug Approvals

No drug approvals found

This company may not have drug approvals in our database

Clinical Trials

Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials

Phase 1
4 (40.0%)
Phase 2
4 (40.0%)
Phase 3
2 (20.0%)

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

Conditions
Diabetic Kidney Disease
Chronic Kidney Disease
Interventions
Biological: Renal Autologous Cell Therapy (REACT)
First Posted Date
2025-01-24
Last Posted Date
2025-01-24
Lead Sponsor
Prokidney
Target Recruit Count
50
Registration Number
NCT06790498
Locations
🇺🇸

Boise Kidney & Hypertension Institute, Meridian, Idaho, United States

A Long-Term Follow-Up Study of Participants Exposed to REACT

Recruiting
Conditions
Diabetic Kidney Disease
Chronic Kidney Diseases
Interventions
Biological: Renal Autologous Cell Therapy (REACT)
First Posted Date
2023-06-26
Last Posted Date
2025-05-28
Lead Sponsor
Prokidney
Target Recruit Count
80
Registration Number
NCT05918523
Locations
🇺🇸

Boise Kidney & Hypertension Institute, Meridian, Idaho, United States

A Study of Participants With Chronic Kidney Disease Previously Treated With REACT

Phase 1
Terminated
Conditions
CAKUT
Chronic Kidney Diseases
Diabetic Kidney Disease
Interventions
Biological: Renal Autologous Cell Therapy (REACT)
First Posted Date
2023-01-23
Last Posted Date
2025-02-28
Lead Sponsor
Prokidney
Target Recruit Count
1
Registration Number
NCT05694169
Locations
🇺🇸

Boise kidney and Hypertension Institute, Boise, Idaho, United States

A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

Phase 3
Recruiting
Conditions
Type 2 Diabetes Mellitus
Chronic Kidney Diseases
Interventions
Biological: Renal Autologous Cell Therapy (REACT)
Procedure: Sham Comparator
First Posted Date
2022-03-18
Last Posted Date
2024-07-26
Lead Sponsor
Prokidney
Target Recruit Count
600
Registration Number
NCT05286853
Locations
🇪🇸

IMIM Hospital del Mar Medical Research Institute, Barcelona, Spain

🇪🇸

Hospital Universitario Vall D'Hebron, Barcelona, Spain

🇪🇸

Hospital Universitario 12 de Octubre, Madrid, Spain

Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

Phase 3
Recruiting
Conditions
Type 2 Diabetes Mellitus
Chronic Kidney Diseases
Interventions
Procedure: Sham Comparator
Biological: Renal Autologous Cell Therapy (REACT)
First Posted Date
2021-10-29
Last Posted Date
2025-07-24
Lead Sponsor
Prokidney
Target Recruit Count
685
Registration Number
NCT05099770
Locations
🇺🇸

University of Arizona, Tucson, Arizona, United States

🇺🇸

Amicis Research Center, Beverly Hills, California, United States

🇺🇸

Paradise Clinical Research Group LLC, Glendora, California, United States

and more 75 locations
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News

ProKidney's Rilparencel Shows 78% Improvement in Kidney Function Decline in Phase 2 CKD Trial

ProKidney reported statistically significant results from the Phase 2 REGEN-007 trial, showing rilparencel improved kidney function decline by 78% in patients with chronic kidney disease and diabetes.

ProKidney Reports Positive Progress in Rilparencel Development for Advanced CKD

ProKidney made significant strides in 2024, refining its Phase 3 program for rilparencel in advanced chronic kidney disease and securing FDA confirmation for potential accelerated approval pathway using eGFR slope as a surrogate endpoint.

Cell and Gene Therapies Show Promise in Treating Diabetes and Related Complications

ProKidney focuses on its US-based Phase 3 trial of rilparencel for type 2 diabetes and chronic kidney disease, discontinuing a trial in Spain.

ProKidney's Rilparencel Receives Positive FDA Feedback on Phase 3 Trial Design and Accelerated Approval Pathway

The FDA has confirmed that ProKidney's PROACT 1 Phase 3 study could be sufficient for full U.S. regulatory approval of rilparencel, a cellular therapy for chronic kidney disease (CKD).

ProKidney Prioritizes US Market for Rilparencel, Discontinuing Ex-US Phase III CKD Trial

ProKidney will discontinue its ex-US Phase III trial (REGEN-016) of rilparencel for chronic kidney disease (CKD) to focus on the US market.

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