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

Prokidney

Status and phase: Completed; Phase 2

Conditions: Chronic Kidney Disease; Type 2 Diabetes Mellitus

Treatments: Biological: Renal Autologous Cell Therapy (REACT); Procedure: Renal Biopsy

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02836574

RMCL-002

Details and patient eligibility

About

To assess the safety and efficacy of up to two REACT injections given 6 months (+4 weeks) apart and delivered into the biopsied kidney using a percutaneous approach in participants with Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD).

Full description

Study Part 1: Multi-center, prospective, open-label, randomized, double-arm, deferred treatment study whereby eligible subjects will be randomized 1:1 after kidney biopsy to receive up to 2 injections of REACT (made from expanded autologous selected renal cells) into the biopsied kidney beginning as soon as REACT can be prepared, or the same series of up to 2 injections given 6 months (+4 weeks) apart beginning 12 months after renal biopsy. Subjects will be followed through 23 months after the last injection.

Study Part 2: An open-label extension study in which eligible subjects will be followed for an additional 36 months of long-term follow-up. Subjects will be able to roll from Study Part 2 into a Long Term Follow-Up Master protocol for up to 5 years

Enrollment: 83 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Study Part 1:

1. The subject is male or female, 30 to 80 years of age on the date of informed consent.
2. The subject has an established diagnosis of Type 2 Diabetes Mellitus.
3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
4. The subject has an established diagnosis of Chronic Kidney Disease not requiring renal dialysis, defined as having an Estimated Glomerular Filtration Rate (eGFR) between 20 and 50 mL/min/1.73m².
5. The subject has blood pressure less than 150/90 at the Screening Visit.
6. The subject has stable blood pressure and is maintained on a stable anti-hypertensive medication regimen.
7. A minimum of 2 measurements of Estimated Glomerular Filtration Rate (eGFR) or serum creatine ratio (sCr) should be obtained at least 3 months apart prior to the Screening Visit or within the previous 18 months to define the rate of progression of Chronic Kidney Disease (CKD).

Exclusion Criteria for Study Part 1:

1. The subject has a history of type 1 diabetes mellitus.
2. The subject has a history of renal transplantation.
3. The subject has a serum Hemoglobin A1c (HbA1c) level greater than 10% at the Screening Visit.
4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator).
5. The subject has hemoglobin levels less than 9 g/dL prior to each Renal Autologous Cell Therapy (REACT) injection.

Inclusion Criteria for Study Part 2:

1. The subject is willing and able to provide signed informed consent.
2. The subject was enrolled into Part 1 of the study and received at least one Renal Autologous Cell Therapy (REACT) injection.

Exclusion Criteria for Study Part 2:

1. The subject is currently receiving renal dialysis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

83 participants in 2 patient groups

Immediate Treatment

Experimental group

Description:

Renal Autologous Cell Therapy (REACT) immediate treatment - Patients who are randomized to receive their first treatment of 2 injections of REACT as soon as REACT product is made available.

Treatment:

Procedure: Renal Biopsy

Biological: Renal Autologous Cell Therapy (REACT)

Delayed Treatment

Active Comparator group

Description:

Renal Autologous Cell Therapy (REACT) delayed treatment - Patients who are randomized to receive standard of care treatment for the first 12 months after REACT product is made available before receiving 2 injections of REACT.

Treatment:

Procedure: Renal Biopsy

Biological: Renal Autologous Cell Therapy (REACT)