ClinicaliQ Trial Snapshot
- Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease — Recruiting • Phase III • Cardiology / Cardiovascular • NCT05099770.
- 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. Lead.
- Sponsor: Prokidney.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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. Lead Sponsor: Prokidney Start Date: 2022-01-05 Primary Completion: 2029-12
Eligibility Snapshot
- Key Inclusion Criteria: 1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease 3. Serum glycosylated hemoglobin (HbA1c) of 9.5% or lower at Screening. 4. Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening. 5. All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). 6. On a clinically relevant, maximally tolerated dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
- Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations.
- Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent. Key
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.