Proact: 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 of up to 2 REACT/rilparencel injections 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 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 criteria
Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.
Inclusion criteria
- The participant is male or female, 30 to 80 years of age on the date of informed consent.
- The participant has a clinical diagnosis of T2DM in their health record.
- The participant has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy) in their health record.
- The participant has a serum glycosylated hemoglobin (HbA1c) less than 9.5% at the Screening Visit.
- The participant has a documented clinical diagnosis of either: eGFR greater than or equal to 20 and less than 30 mL/min/1.73m², not requiring renal dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol) OR: eGFR of 30 to less than or equal to 35 mL/min/1.73m² AND UACR of 300 to less than or equal to 5000mg/g (33.9 mg/mmol to less than or equal to 565 mg/mmol).
- Systolic blood pressure of ≤ 140 mm Hg and diastolic blood pressure of ≤ 90 mm Hg at Screening (based on the average of 3 measurements obtained while seated) and maintained during the screening period until randomization.
- On a clinically relevant and stable dose of an angiotensin converting-enzyme inhibitor (ACEI) OR an angiotensin receptor blocker (ARB), unless not tolerated or contraindicated.
Exclusion criteria
- The participant has a history of type 1 diabetes mellitus.
- The participant has a history of renal transplantation or other organ transplantation (corneal transplants are not an exclusion), solitary kidney, recurrent complicated urinary tract infections or complicated kidney stones. Urinary tract infections identified prior to renal biopsy or injection should be resolved prior to procedures.
- The participant has any other known underlying cause of kidney disease, including but not limited to: Autosomal dominant and recessive polycystic kidney disease, primary focal segmental glomerulosclerosis, vasculitis related CKD, IgA nephropathy and other immune modulated nephropathies, drug-induced CKD or other types of CKD or anatomic variants as determined by the Investigator or Sponsor that would interfere with biopsy and REACT injection procedure or confound study assessments.
- History of acute kidney injury within 3 months prior to the Screening Visit.
- Myocardial infarction, unstable angina, revascularization procedure (e.g. stent or bypass graft surgery), or cerebrovascular accident within 12 weeks before randomization, or a revascularization procedure is planned during the trial.
Eligibility
Age eligible for study : NA
Healthy volunteers accepted : No
Gender eligible for study: ALL
Things to know
Study dates
Study start:
Primary completion:
Study completion finish:
Study type
TREATMENT
Phase
- PHASE3
Study ID
NCT05099770
Intervention or treatment
BIOLOGICAL: Renal Autologous Cell Therapy (REACT)
PROCEDURE: Sham Comparator
Conditions
- Type 2 Diabetes Mellitus
- Chronic Kidney Diseases
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Research sites nearby
Closest Location:
St. George Hospital
Select from list below to view details:
St. George Hospital
Kogarah, New South Wales, Australia
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Who is running the clinical trial?
Prokidney
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/rilparencel injections)
| Biological: Renal Autologous Cell Therapy (REACT/ rilparencel) |
What is the study measuring?
Primary Outcome
| Measure | Description | 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
| Measure | Description | 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 |
References
Clinical Trials Gov: Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney DiseaseOther trials to consider
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