Clinical Trials
12
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
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Clinical Trials
Distribution across different clinical trial phases (10 trials with phase data)• Click on a phase to view related trials
Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product
- Conditions
- Diabetic Kidney DiseaseChronic 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
- Conditions
- Diabetic Kidney DiseaseChronic 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
- Conditions
- CAKUTChronic Kidney DiseasesDiabetic 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
- Conditions
- Type 2 Diabetes MellitusChronic 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
- Conditions
- Type 2 Diabetes MellitusChronic Kidney Diseases
- Interventions
- Procedure: Sham ComparatorBiological: 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
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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.