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A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT injections given 3 months (+30 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Study details:
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 undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date.
This event driven study is estimated to have a total maximum duration of 5 years.
Eligibility criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
Exclusion criteria
Eligibility
Age eligible for study : 30 and older
Healthy volunteers accepted : No
Gender eligible for study: All
Things to know
Study dates
Study start: 2022-01-05
Primary completion: 2027-02-01
Study completion finish: 2027-02-01
Study type
TREATMENT
Phase
PHASE3
Trial ID
NCT05099770
Intervention or treatment
BIOLOGICAL: Renal Autologous Cell Therapy (REACT)
PROCEDURE: Sham Comparator
Conditions
- • Type 2 Diabetes Mellitus
- • Chronic Kidney Diseases
Find a site
Closest Location:
St. George Hospital
Research sites nearby
Select from list below to view details:
St. George Hospital
Kogarah, New South Wales, Australia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Participant Group/Arm | Intervention/Treatment |
---|---|
SHAM_COMPARATOR: Sham Procedure
| PROCEDURE: Sham Comparator
|
EXPERIMENTAL: Experimental (REACT injections)
| BIOLOGICAL: Renal Autologous Cell Therapy (REACT)
|
What is the study measuring?
Primary outcome
Primary Outcome Measure | Primary Outcome Description | Primary Outcome Time Frame |
---|---|---|
Primary Composite Endpoint | The time from first injection to the earliest of: * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or * eGFR \<15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or Renal or cardiovascular death | up to 60 Months |
Secondary outcome
Secondary Outcome Measure | Secondary Outcome Description | Secondary Outcome Time Frame |
---|---|---|
Secondary Composite Endpoint: Change in eGFR | • Annualized change in eGFR | up to 60 Months |
Secondary Composite Endpoint: Change in eGFR from first injection | • Time from first injection to at least a 40% reduction in eGFR sustained for 30 days. | up to 60 Months |
Secondary Composite Endpoint: Change in eGFR from first injection to End Stage Renal Disease (ESRD) | • Time from first injection to eGFR \< 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or renal transplant. | up to 60 Months |
Secondary Composite Endpoint: Mortality | The time from first injection to all-cause mortality. | up to 60 Months |
Secondary Composite Endpoint: Quality of Life Changes | • Changes from Baseline in patient-reported outcome from the Kidney Disease Quality of Life (KDQOL) survey. The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life. | up to 60 Months |
Secondary Composite Endpoint: Quality of Life | • Changes from Baseline in patient-reported outcomes from the EuroQol 5-Dimension 5 Level (EQ-5D-5L) survey. The descriptive system is divided into 5 levels of perceived problems with level 1 (indicating no problem) and level 5 (indicating extreme problems). | up to 60 Months |
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