Overview
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.
Description
Randomized multi-center, blinded intervention, two cohort, study whereby eligible participants will be randomized 1:1, prior to kidney biopsy, to 1 of 2 cohorts. Cohort 1 participants will have scripted sham procedures that mimic the sounds and activities of biopsy, injection procedures, and evaluations as a control for Cohort 2 participants who will have a kidney biopsy followed with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later with a second rilparencel injection into the contralateral kidney. All participants will be followed until the global trial end date is declared.
Eligibility
Key Inclusion Criteria:
- 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.
- All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i).
- 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 Exclusion Criteria:
- 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.
- Myocardial infarction, unstable angina, revascularization procedure or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
- Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
- History of exclusionary malignancy within the past 3 years prior to Screening
- Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C.
- Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
- Immunocompromised condition or condition requiring chronic immunosuppressive agents, including individuals treated for chronic glomerulonephritis, within 3 months of signing ICF.
- Has had a recent bleeding event or a known bleeding disorder(s) or increased risk of either thromboembolism or bleeding.
- Kidney imaging reveals contraindications for undergoing biopsy or rilparencel injection
- Maintained on any anticoagulant agents
- History of anaphylactic or severe systemic reaction(s) to blood transfusions, Dextran 40, or bovine products, or contraindication(s) to above products due to medical reasons or participant preference.
- History of severe systemic reaction(s) or any contraindication to local anesthetics or sedatives.
- Use of an investigational product or device within 12 weeks prior to Randomization or previous treatment with rilparencel.
- Participant's health status would, in the judgement of the Investigator, be jeopardized by participating in the study.