Recruiting NCT05099770

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

Phase III Interventional Type 2 Diabetes Mellitus Chronic Kidney Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Renal Autologous Cell Therapy (REACT/ rilparencel), Sham Comparator.
Who it may be relevant to: Registry conditions: Type 2 Diabetes Mellitus, Chronic Kidney Diseases. Basic parameters: 30 years — 80 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Canada, Mexico, Puerto Rico +2
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Overview

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.

Detailed description

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.

Interventions

Biological Renal Autologous Cell Therapy (REACT/ rilparencel)
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.
Procedure Sham Comparator
Participants will have sham procedures that simulate real biopsy and injection procedure. No tissue is taken during biopsy and nothing is injected into kidney. The 2 injection/ sham procedures will occur approximately 12 weeks apart.

Primary outcome measures

Surrogate / Intermediate Efficacy Endpoint -eGFR Slope [Time frame: 18 months after the 135th participant receives their first injection / sham.]
Clinical Endpoint [Time frame: From date of first injection until the date of first event: 40% reduction in eGFR, eGFR < 15 mL/min/1.73m² and/or chronic dialysis, and or renal transplant or date of renal or cardiovascular death, whichever came first, assessed up to 94 months.]

Secondary outcome measures (5)

Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days. [Time frame: From date of first injection until the date of 40% reduction in eGFR assessed up to 94 months.]
Secondary Endpoint: Time from first injection to eGFR < 15 mL/min/1.73m² sustained for 30 days and/or chronic dialysis, and/or kidney transplant. [Time frame: From date of first injection until the date of eGFR < 15 mL/min/1.73m² assessed up to 94 months.]
Secondary Endpoint: All-cause mortality. [Time frame: From date of first injection to all-cause mortality assessed up to 94 months.]
Secondary Endpoint: Kidney Disease Quality of Life Changes [Time frame: Week 52]
Secondary Endpoint: Quality of Life [Time frame: Week 52]

Eligibility criteria

Inclusion 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.

Exclusion criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Triple blind
Primary purpose: Treatment