Clinical trial NCT05018416: Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Official title: A Phase 2, Randomized, Open-Labeled, Repeat Dose, Safety and Efficacy Study of Renal Autologous Cell Therapy (REACT) in Subjects With Type 1 or 2 Diabetes and Chronic Kidney Disease (REGEN-007)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Chronic Kidney Diseases
Type 1 Diabetes Mellitus
Type 2 Diabetes Mellitus
Keywords: Kidney Biopsy
REACT
Lead sponsor: Prokidney
Sponsor class: INDUSTRY
First posted: 2021-08-24
Enrollment: 53
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD.

Detailed description: The objective of this study is to assess the safety, efficacy, and durability of up to two REACT injections delivered percutaneously into biopsied and non-biopsied contralateral kidneys on renal function progression in two different cohorts of subjects with T1DM or T2DM and CKD:

* Cohort 1: Two scheduled REACT injections given 3 months (+60 days) with at least 18- month follow-up
* Cohort 2: One scheduled REACT injection with a possible second REACT injection, no less than 3 months after the first one, within 30 days (+30 days) of meeting a renal function redose trigger (triggered up to 15 months following the first REACT injection).

Both cohorts will be followed for 18 months after the final REACT injection. If a Cohort 2 subject does not meet a trigger, the subject will be followed for at least 18 months after the first injection.

Eligibility criteria: Inclusion Criteria:

1. Male or female aged 30 to 80 years, inclusive, on the date informed consent is signed.
2. Clinical diagnosis of T1DM or T2DM, controlled per institutional standard of care.
3. The subject has a clinical diagnosis of diabetic nephropathy as the underlying cause of renal disease (diagnosis does not have to be confirmed via renal biopsy).
4. The subject has a serum glycosylated hemoglobin (HbA1c) level less than 10% at the Screening Visit.
5. The subject has a documented clinical diagnosis of an eGFR between 20 and 50 mL/min/1.73m² inclusive not requiring renal dialysis.

Exclusion Criteria:

1. The subject has a history of renal transplantation.
2. The subject 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.

   Subjects with blood pressure outside of this range prior to biopsy/injection may continue if approved by the Medical Monitor.
3. The subject has hemoglobin levels less than 10 g/dL and is not responsive to the standard medical intervention for CKD-related anemia prior to randomization.

Primary outcomes:
measure: Improvement in renal function progression rate as indicated by the change from pre-injection baseline value in total (acute + chronic) slope of estimated glomerular filtration rate (eGFR) using the CKD-EPI 2009 equation
timeFrame: Screening thru month 28
measure: Procedural and investigational product-related treatment-emergent adverse events (TEAEs) obtained through 18 months after the last REACT injection.
timeFrame: Screening thru 18 months after the last injection of study drug
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: Kidney Associates of Colorado, P.C. - Frenova
state: Colorado
city: Newark
country: United States
facility: Nephrology Associates
state: Delaware
city: Nampa
country: United States
facility: Boise Kidney and Hypertension Institute - Frenova
state: Idaho
city: Kalamazoo
country: United States
facility: Paragon Health, PC d/b/a Nephrology Center, PC - Frenova
state: Michigan
city: Tupelo
country: United States
facility: Nephrology and Hypertension Associates Ltd - Frenova
state: Mississippi
Study officials:
affiliation: Prokidney
name: Ashley Johns
role: STUDY_DIRECTOR
References: