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ProKidney (PROK)
NASDAQ:PROK
Renal Autologous Cell Therapy (React)
Chronic Kidney Diseases, Diabetic Kidney Disease, Cakut
Phase I
Terminated
A Study of Participants With Chronic Kidney Disease Previously Treated With REACT
Dec 27, 2022
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Renal Autologous Cell Therapy (React), Sham Comparator
Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Phase III
Recruiting
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Oct 18, 2021
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Renal Autologous Cell Therapy (React)
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Phase II
Completed
Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Aug 17, 2021
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Renal Autologous Cell Therapy (React)
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Phase II
Completed
A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease
Aug 25, 2017
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Renal Autologous Cell Therapy (React), Renal Biopsy
Chronic Kidney Disease, Type 2 Diabetes Mellitus
Phase II
Completed
A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease
Jun 22, 2016
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does ProKidney (PROK) have in its pipeline
PROK is currently developing the following drugs: Renal Autologous Cell Therapy (React), Renal Autologous Cell Therapy (React), Sham Comparator, Renal Autologous Cell Therapy (React). These drug candidates are in various stages of clinical development as the company works toward FDA approval.