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

P

Prokidney

Status and phase

Active, not recruiting
Phase 3

Conditions

Chronic Kidney Diseases
Type 2 Diabetes Mellitus

Treatments

Biological: Renal Autologous Cell Therapy (REACT)

Study type

Interventional

Funder types

Industry

Identifiers

NCT05099770
REGEN-006

Details and patient eligibility

About

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.

Full 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 undergo sham procedures and be followed to the global trial end date. Cohort 2 participants will receive 2 REACT injections 3 months apart (+30 days) and be followed to the global trial end date. This event driven study is estimated to have a total maximum duration of 5 years.

Enrollment

600 estimated patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • The participant is male or female, 30 to 80 years of age on the date of informed consent.
  • The participant has a clinical diagnosis of T2DM in their health record.
  • 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.
  • The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
  • The participant has a documented clinical diagnosis of an eGFR greater than or equal to 20 and less than or equal to 50 mL/min/1.73m², not requiring renal dialysis.
  • The participant has a 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

  • The participant has a history of type 1 diabetes mellitus.
  • The participant has a history of renal transplantation.
  • 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.
  • The participant has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

600 participants in 2 patient groups

Cohort 1
Sham Comparator group
Description:
Participants randomized to Cohort 1 will receive 2 sham injections of REACT. Second injection to occur 3 months (+30 days) after the first REACT injection. Sham procedures simulate real procedure. No tissue is taken during biopsy and nothing is injected into kidney for injection.
Treatment:
Biological: Renal Autologous Cell Therapy (REACT)
Cohort 2
Experimental group
Description:
Participants randomized to Cohort 2 will receive 2 injections of REACT. The second injection to occur 3 months (+30 days) after the first REACT injection.
Treatment:
Biological: Renal Autologous Cell Therapy (REACT)

Trial contacts and locations

46

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Central trial contact

Mignon Keaton; Jessica Schmidt

Data sourced from clinicaltrials.gov

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