A Study of Renal Autologous Cell Therapy (REACT) in Participants With Type 2 Diabetes and Chronic Kidney Disease

Prokidney

Overview

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.

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 for 5 years post last simulated injection.. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed for 5 years post last injection of the investigational product.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Type 2 Diabetes Mellitus Chronic Kidney Diseases

Interventions

Renal Autologous Cell Therapy (REACT)BIOLOGICAL

Participants receiving institutional standard of care will have a kidney biopsy followed by 2 REACT injections into biopsied and non-biopsied contralateral kidneys 3 months (+30 days) apart and will be followed for 5 years (60 months) since last REACT injection.

Sham ComparatorPROCEDURE

Participants receiving institutional standard of care 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 3 months (+30 days) after the first sham procedure. Participants will be followed for 5 years (60 months) since last sham REACT injection.

Eligibility

Sex: ALLMin age: 30 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The participant is male or female, 30 to 80 years of age on the date of informed consent. 2. The participant has a clinical diagnosis of T2DM in their health record. 3. 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. 4. The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit. 5. The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 44 mL/min/1.73m², not requiring renal dialysis. 6. The participant has an urinary albumin-to-creatinine ratio (UACR) of greater than or equal to 300 and less than or equal to 5,000 mg/g. Exclusion Criteria: 1. The participant has a history of type 1 diabetes mellitus. 2. The participant has a history of renal transplantation. 3. The participant has a mean systolic blood pressure greater than or equal to 140 mmHg and/or mean diastolic blood pressure greater than or equal to 90 mmHg at screening, across 3 measurements while seated. 4. The participant has hemoglobin level less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Locations (3)

IMIM Hospital del Mar Medical Research Institute

Barcelona, Spain

Hospital Universitario Vall D'Hebron

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Outcomes

Primary Outcomes

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 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or * Renal or cardiovascular death

Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection.

Secondary Outcomes

First Secondary Endpoint: Time to progression of Chronic Kidney Disease

Time to progression of Chronic Kidney Disease * At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or * eGFR \<15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or or * Renal death

Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection

Second Secondary Endpoint: Time to End Stage Renal Disease

Time to End Stage Renal Disease * 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 death.

Time frame: up to 60 Months post last injection of the investigational product or the last simulated injection

Data from ClinicalTrials.gov

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