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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03270956
Other study ID # REGEN-003
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 25, 2018
Est. completion date November 17, 2022

Study information

Verified date January 2023
Source Prokidney
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date November 17, 2022
Est. primary completion date November 17, 2022
Accepts healthy volunteers No
Gender All
Age group 30 Years to 65 Years
Eligibility Inclusion Criteria: 1. The subject is male or female, 30 to 65 years of age on the date of informed consent. 2. The subject has an established diagnosis of T2DM. 3. The subject has an established diagnosis of diabetic nephropathy as the underlying cause of renal disease. 4. 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. 5. 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. 6. 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: 1. The subject has a history of type 1 diabetes mellitus. 2. The subject has a history of renal transplantation. 3. The subject has a serum HbA1c level greater than 10% at the Screening Visit. 4. The subject has uncontrolled diabetes (defined as metabolically unstable by the Investigator). 5. The subject has hemoglobin levels less than 9 g/dL prior to each REACT injection.

Study Design


Intervention

Biological:
Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)

Locations

Country Name City State
United States Boise Kidney & Hypertension Institute Boise Idaho
United States University of North Carolina- Chapel Hill Chapel Hill North Carolina
United States Vanderbilt University [WITHDRAWN] Nashville Tennessee
United States University of Arizona [WITHDRAWN] Tucson Arizona

Sponsors (2)

Lead Sponsor Collaborator
Prokidney CTI Clinical Trial and Consulting Services

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Procedure and/or product related adverse events Incidence (percentage of subjects) with procedure and/or product related adverse events by System Order Class and Preferred Term Through 24 months following last REACT injection
Secondary Renal specific adverse events Incidence (percentage of subjects) with renal-specific adverse events by System Order Class and Preferred Term Through 24 months following last REACT injection
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