Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorProkidney
About this trial
The purpose of this study is to assess the safety and efficacy of up to 2 REACT/rilparencel injections in participants with T2DM and CKD.
Eligibility criteria
Qualifiers
The participant is male or female, 30 to 80 years of age on the date of informed consent.
Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening.
Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening.
Disqualifiers
The participant has a history of type 1 diabetes mellitus.
The participant has a history of renal transplantation or other organ transplantation
The participant has any other known underlying cause of kidney disease
History of acute kidney injury or major surgery within 3 months prior to the Screening Visit.
Trial design
Treatments tested in this trial
- Renal Autologous Cell Therapy (REACT/ rilparencel)
- Sham Comparator
Treatment groups
685 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov