A Study of Renal Autologous Cell Therapy (REACT®) in Participants With Type 2 Diabetes and Chronic Kidney Disease
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed 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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Cohort 1 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. |
Biological: Renal Autologous Cell Therapy (REACT®)
Participants will receive either 2 REACT® injections or 2 Sham REACT® injections into biopsied and non-biopsied contralateral kidneys 3 months apart.
|
| Experimental: Cohort 2 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. |
Biological: Renal Autologous Cell Therapy (REACT®)
Participants will receive either 2 REACT® injections or 2 Sham REACT® injections into biopsied and non-biopsied contralateral kidneys 3 months apart.
|
Outcome Measures
Primary Outcome Measures
- Primary Composite Endpoint [up to 60 Months]
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15 mL/min/1.73m² using the 2009 serum creatinine equation, sustained for 30 days and/or chronic dialysis , and/or renal transplant or Renal or cardiovascular death
Secondary Outcome Measures
- Secondary Composite Endpoint [up to 60 Months]
The time from first injection to the earliest of: At least 40% reduction in eGFR, using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days or eGFR <15mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation, sustained for 30 days and/or chronic dialysis, and/or renal transplant or Increase of UACR of at least 30% and of at least 30mg/g, using the random urine microalbumin/urine creatinine ratio sustained for 90 days or Renal or cardiovascular death
Eligibility Criteria
Criteria
Inclusion Criteria:
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The participant is male or female, 30 to 80 years of age on the date of informed consent.
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The participant has a clinical diagnosis of T2DM in their health record.
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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.
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The participant has a serum glycosylated hemoglobin (HbA1c) less than 10% at the Screening Visit.
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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.
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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.
Exclusion Criteria:
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The participant has a history of type 1 diabetes mellitus.
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The participant has a history of renal transplantation.
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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.
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Prokidney
- Iqvia Pty Ltd
Investigators
- Study Director: Ashley Johns, SVP Clinical Operations, ProKidney
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REGEN-016