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Completed

NCT Number: NCT03270956

A Study of Autologous Renal Autologous Cell Therapy (REACT) in Patients With Diabetic Chronic Kidney Disease

The purpose of the present study is to assess the safety and efficacy of up to 2 injections of REACT given 6 months (+4 weeks) apart (maximum).

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Key information

Conditions

Type 2 Diabetes Mellitus Chronic Disease Chronic Kidney Disease Diabetes Mellitus Diabetes Mellitus, Type 2 Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Arizona [WITHDRAWN], Tucson, Arizona, United States

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About this study

All subjects enrolled will receive REACT. Subjects will receive their first REACT injection as soon as the REACT product is manufactured and shipped to the clinical site. After 6 months (+4 weeks), a second injection will be given, as appropriate. Each subject's baseline rate of renal decline, based on adequate historical clinical data obtained 24 months prior to screening visit, will serve as a comparator for monitoring the rate of progression of renal insufficiency over time.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The subject is male or female, 30 to 65 years of age on the date of informed consent.
  • The subject has an established diagnosis of T2DM.
  • The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease.
  • The subject has an established diagnosis of CKD not requiring renal dialysis, defined as having an eGFR between 14 and 20 mL/min/1.73m² inclusive at the Screening Visit and prior to REACT injection.
  • The subject has blood pressure less than 150/90 at the Screening Visit, prior to renal biopsy, and prior to REACT injection(s). Note BP should not be significantly below the previously recorded stable pressure.
  • A minimum of 3 measurements of eGFR or sCr should be obtained at least 3 months apart prior to the Screening Visit or within the previous 24 months to define the rate of progression of CKD. The subject should have adequate, historical clinical data to provide a reasonable estimate of the rate of progression of CKD. The Medical Monitor may be consulted to ensure there is sufficient data.

Exclusion criteria

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

Treatment and study plan

Renal Autologous Cell Therapy (REACT)

Biological

Autologous selected renal cells (SRC)

Primary outcomes

  1. Procedure and/or Product Related Adverse Events

    Time frame: Through 24 months following last REACT injection

    Percentage of subjects with procedures and/or product related adverse events by System Organ Class and Preferred Term

Secondary outcomes

  1. Renal Specific Adverse Events

    Time frame: Through 24 months following last REACT injection

    Percentage of subjects with renal-specific adverse events by System Order Class and Preferred Term

Sponsors and collaborators

Lead sponsor

Prokidney

Industry

Collaborators

  • CTI Clinical Trial and Consulting Services

Registry information

Official study title

A Phase II, Open-Label Safety and Tolerability Study of an Renal Autologous Cell Therapy (REACT) in Patients With Type 2 Diabetes and Chronic Kidney Disease (REGEN-003)

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 1, 2017
Registry last updated
Mar 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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