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A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease

PHASE3RECRUITING

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.

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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.

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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.

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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

Image related to Type 2 Diabetes Mellitus

Condition: Type 2 Diabetes Mellitus, Chronic Kidney Diseases
BIOLOGICAL: Renal Autologous Cell Therapy (REACT) and other drugs
Kogarah, New South Wales, Australia
Sponsor: Prokidney

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

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 Participants randomized to the Sham Comparator arm will have 2 sham procedures.	PROCEDURE: Sham Comparator Participants will have 2 sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The second sham procedure will occur 12 weeks (+28 days) after the first sham procedure.
EXPERIMENTAL: Experimental (REACT injections) Participants randomized to the experimental arm will receive 2 injections of REACT.	BIOLOGICAL: Renal Autologous Cell Therapy (REACT) Participants will have a kidney biopsy followed 14 weeks later with a REACT injection into the biopsied kidney, then, another 12 weeks (+28 days) later a REACT injection into their contralateral kidney.

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

Frequently Asked Questions

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References

Clinical Trials Gov: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease