At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Renal Autologous Cell Therapy (REACT/ rilparencel) (biological), Sham Comparator (procedure)
- How long the study runs
- Study runs about 95 months (dates as stated)
- About the drug or intervention
- Renal Autologous Cell Therapy (REACT/ rilparencel) — biological: Participants will have a kidney biopsy followed approximately12 weeks later with a rilparencel injection into the biopsied kidney, then, approximately 12 weeks later a rilparencel injection into their contralateral kidney. · Sham Comparator — procedure: Participants will have sham procedures that simulate real biopsy and injection procedure.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 30 Years to 80 Years
- Who
- All
- Number of participants
- 685
- Started
- 2022-01-05
- Last checked
- 2026-08
Plain English Summary
What is this study?
- • Testing a new treatment for type 2 diabetes mellitus
- • Phase3 - 685 participants
- • 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
Who can take part?
- • Ages 30 Years to 80 Years
- • Diagnosed with type 2 diabetes mellitus
Where?
- • No UK sites listed for this trial
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 30 Years - 80 Years
- Who can join: All genders
What the study is looking for
- ✓The participant is male or female, 30 to 80 years of age on the date of agreement to take part.
- ✓Documented diagnosis of type 2 diabetes mellitus (T2DM) and chronic kidney disease
- ✓Serum glycosylated red blood cell level (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).
Who cannot take part
- ✗The participant has a history of type 1 diabetes mellitus.
- ✗The participant has a history of kidney 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...
