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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE3
NCT ID
NCT05099770
Trial Summary
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
Participants: ALL
Start Date: 2022-01-05
Primary Completion: 2029-12
Min Age: 30 Years
Max Age: 80 Years
Eligibility Criteria
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. 7. Participant agrees and is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and post-procedure durations. 8. Participant is willing and able to cooperate with all aspects of the protocol and provide signed informed consent. Key Exclusion Criteria: 1. The participant has a history of type 1 diabetes mellitus. 2. The participant has a history of renal transplantation or other organ transplantation 3. The participant has any other known underlying cause of kidney disease 4. History of acute kidney injury or major surgery within 3 months prior…
Data sourced from ClinicalTrials.gov. Trial details may change — always check the primary source before clinical decisions.