Summary

Eligibility
for people ages 30-80 (full criteria)
Location
at UC Davis
Dates
study started
completion around

Description

Summary

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.

Official Title

A Phase 3 Randomized Controlled Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 2 Diabetes and Chronic Kidney Disease (REGEN-006)

Details

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.

Keywords

Type 2 Diabetes Mellitus, Chronic Kidney Diseases, REACT®, Kidney Diseases, Chronic Renal Insufficiency, Diabetes Mellitus, Renal Autologous Cell Therapy (REACT)

Eligibility

You can join if…

Open to people ages 30-80

  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 50 mL/min/1.73m², not requiring renal dialysis.
  6. 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.

You CAN'T join if...

  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 levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Locations

  • UC Davis Medical Group GI Unit
    Sacramento California 95817 United States
  • Allameh Medical Corporation
    Mission Viejo California 92691 United States
  • Valley Clinical Trials
    Northridge California 91325 United States
  • IMD Clinical Trials
    Huntington Park California 90255 United States
  • Medicine and Nephrology Associates
    Los Alamitos California 90720 United States
  • Academic Medical Research Institute
    Los Angeles California 90022 United States
  • Integrity Medical Discovery
    Pico Rivera California 90660 United States
  • Advanced Medical Research, LLC
    Lakewood California 90712 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Prokidney
ID
NCT05099770
Phase
Phase 3 research study
Study Type
Interventional
Participants
Expecting 600 study participants
Last Updated