RecruitingPhase 3NCT05099770
Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)
Sponsor
Prokidney
Enrollment
685 participants
Start Date
Jan 5, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The purpose of this study is to assess the safety and efficacy (including durability) of up to 2 REACT/rilparencel injections given 12 weeks (-14 days to +28 days) apart and delivered percutaneously into biopsied and non-biopsied contralateral kidneys in participants with T2DM and CKD.
Eligibility
Min Age: 30 YearsMax Age: 80 Years
Inclusion Criteria18
- 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 as the underlying cause of kidney disease (diagnosis does not have to be confirmed by kidney biopsy).
- eGFR of at least 20 mL/min/1.73 m2 AND \<30 mL/min/1.73 m2, not requiring kidney dialysis. UACR level cannot exceed 5000 mg/g (565 mg/mmol), OR
- eGFR of 30 to ≤ 35 mL/min/1.73m2 AND UACR of 300 to ≤ 5000 mg/g (33.9 mg/mmol to ≤565 mg/mmol).
- 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, based on average of 3 consecutive measurements obtained seated or supine. Note: Retesting may be performed if initial screening blood pressure exceeds eligibility criteria for systolic and/or diastolic blood pressure. Changes in blood pressure Page 46 of 113 CONFIDENTIAL ProKidney Renal Autologous Cell Therapy Clinical Protocol REGEN-006 USAN/INN: Rilparencel Version 6.0 medications will be recorded in the appropriate eCRF. (refer to BP procedures)
- All participants should be strongly considered for treatment with sodium-glucose cotransporter 2 inhibitor (SGLT2i). For participants on SGLT2i medications, the dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving SGLT2i therapy at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
- 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. The dose must be stable for at least 4 weeks prior to randomization. Note: The reason for a participant NOT receiving an ACEI or ARB at the time of randomization will be documented in the eCRF. (See Section 7.1 for additional guidance about Concomitant Therapies).
- Participant agrees, and in the judgement of the Investigator, is able to refrain from using therapies that may increase bleeding risk for the specified pre-procedure and postprocedure (biopsy/sham biopsy and rilparencel/sham injections) durations in the discretion of the PI in consultation with the treating physician, in accordance with the required minimum medication-specific guidelines for high-risk procedures59 and patients with advanced CKD.
- Nonsteroidal anti-inflammatory drugs (NSAIDS) such as ibuprofen and naproxen
- Aspirin
- Platelet aggregation inhibitors (PAIs) such as clopidogrel, prasugrel, and dipyridamole
- Factor Xa inhibitors
- Warfarin
- Heparin products
- Other anticoagulation.
- Participant is willing and able to cooperate with all aspects of the protocol.
- Participant is willing and able to provide signed informed consent.
Exclusion Criteria13
- 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 rilparencel injection procedure or confound study assessments.
- Note: The following are not considered exclusionary under the following conditions: (Unique situations should be discussed with the study Medical Monitor.)
- Concomitant hypertension-related CKD
- Anatomic abnormalities and benign conditions are not exclusionary if the kidney has accessible kidney cortex for biopsy and injection procedures and meets the criteria to receive the rilparencel injection.
- Abnormalities on kidney biopsy (e.g., secondary focal segmental glomerulosclerosis) which are considered secondary to diabetes with the following conditions: lack of other identifiable etiology, full evaluation for other etiologies, no specific treatment administered other than diabetes management.
- History of acute kidney injury or major surgery (based on the judgement of the Investigator and Medical Monitor) 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.
- Current or history of heart failure of New York Heart Association (NYHA) Class IV cardiac disease.
- History of malignancy within the past 3 years prior to Screening, except for basal cell and/or squamous cell carcinomas of the skin with apparent successful curative therapy, carcinoma of the cervix in situ, or a malignancy that in the opinion of the Investigator, along with agreement from the Medical Monitor, is considered treated with no evidence of disease and at minimal risk of recurrence.
- Documented clinically significant liver disease, including acute or chronic hepatitis B or hepatitis C. Note: At the discretion of the Investigator, a participant who gives a history of a treated and cured Hepatitis C infection may be screened with a test for viral ribonucleic acid (RNA), and if a cure is demonstrated, the participant may be enrolled.
- Known infection with HIV, active syphilis, or other unresolved active genitourinary infection, or active tuberculosis requiring treatment at Screening.
Interventions
BIOLOGICALRenal 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.
PROCEDURESham 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.
Locations(86)
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NCT05099770
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