Proact: A Study of REACT in Subjects With Type 2 Diabetes Mellitus and Chronic Kidney Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age30-80
SponsorProkidney
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Renal Autologous Cell Therapy (REACT/ rilparencel)
Biological/VaccineParticipants 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.
Sham Comparator
Procedure/SurgeryParticipants 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.
Treatment groups
685 Participants
are divided into 2 treatment groupsGroup A: Sham ProcedureSham comparator 1 intervention
Group B: Experimental (REACT/rilparencel injections)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Surrogate / Intermediate Efficacy Endpoint -eGFR Slope
The difference in annualized eGFR slope between the rilparencel and sham cohorts (approximately 18 months after the 135th participant receives their first injection/sham) using the 2021 Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) serum creatinine-based equation.
Time frame
18 months after the 135th participant receives their first injection / sham.2
Clinical Endpoint
The time from first injection to the earliest of: * At least 40% reduction in eGFR, sustained for 30 days, OR * eGFR \<15 mL/min/1.73m² with corresponding two-sided 95% CI, sustained for 30 days and/or chronic dialysis, and/or kidney transplant OR * Renal or cardiovascular death
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 outcomes
1
Secondary Endpoint: Time from first injection to at least a 40% reduction in eGFR sustained for 30 days.
• 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.2
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 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.3
Secondary Endpoint: All-cause mortality.
The time from first injection to all-cause mortality.
Time frame
From date of first injection to all-cause mortality assessed up to 94 months.4
Secondary Endpoint: Kidney Disease Quality of Life Changes
• Changes from Baseline in patient-reported outcome from the Burden of Kidney Disease domain at Week 52 from the Kidney Disease Quality of Life (KDQOL) Questionnaire. The survey is used to assess the burden, symptoms/problems, and effects of kidney disease on a patient's quality of life.
Time frame
Week 52 Source ClinicalTrials.gov