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WithdrawnPhase 3

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

Key facts

Who runs it
Prokidney
Where
Spain3 sites in 1 countryChoose a country to see its sites
Trial code
Status
Withdrawn
Phase
Phase 3
Started
17 Jul 2024
Ended
3 Sept 2024
Type of study
Interventional, 2 groupsOne group gets a sham (pretend) treatment, for comparison.
Treatments tested
  • Renal Autologous Cell Therapy (REACT)
  • Sham Comparator
Record updated
25 September 2024
Why it stopped
Rilparencel is eligible for initial FDA/ RMAT approval pathway upon successful completion Phase3 REGEN006 (PROACT1) trial. Discontinued Phase3 REGEN016 (PROACT2) focused on enrollment outside the US and is not required for initial US registration.

Who can take part

Age
30 years to 80 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • 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 44 mL/min/1.73m², not requiring renal dialysis
  • 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

Who cannot take part

  • The participant has a history of type 1 diabetes mellitus
  • The participant has a history of renal transplantation
  • 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
  • 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

This trial has no sites in United States.

It has sites in one country. Choose a country to see its sites.

About the trial

What the trial wants to find out

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.

The 2 groups in the trial

  • Sham ProcedureSham treatment, for comparison

    Participants randomized to the Sham Comparator arm will have 2 sham procedures

    Treatment: Sham Comparator

  • Experimental (REACT injections)Treatment being tested

    Participants randomized to the experimental arm will receive 2 injections of REACT.

    Treatment: Renal Autologous Cell Therapy (REACT)

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Phase 3 Randomized Controlled Study of REACT in Participants With Type 2 Diabetes and Chronic Kidney Disease (REGEN-016)
Record updated
25 September 2024