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New treatment option for Type 2 Diabetes Mellitus
Official title Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
ClinicalTrials.gov ID: NCT05099770
What this study is testing
What is Renal Autologous Cell Therapy (REACT/ rilparencel)?
Renal Autologous Cell Therapy (REACT/ rilparencel) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for type 2 diabetes mellitus.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 30 to 80
You may be able to join if
- 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).
You likely can't join if
- 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...
- Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
See the full eligibility 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
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Huntsville, Alabama, United States
- Tucson, Arizona, United States
- Beverly Hills, California, United States
- Glendora, California, United States
- Granada Hills, California, United States
- Huntington Park, California, United States
- Lakewood, California, United States
- Los Alamitos, California, United States
- Los Angeles, California, United States
- Mission Viejo, California, United States
- Monterey Park, California, United States
- Northridge, California, United States
- Pico Rivera, California, United States
- Pomona, California, United States
- Riverside, California, United States
- Sacramento, California, United States
- San Dimas, California, United States
- Valencia, California, United States
- Newark, Delaware, United States
- Coral Springs, Florida, United States
+ 55 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 30 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Huntsville, Alabama, United States; Tucson, Arizona, United States; Beverly Hills, California, United States; Glendora, California, United States; Granada Hills, California, United States; Huntington Park, California, United States and 69 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.