A Phase 1 interventional study of Renal Autologous Cell Therapy (REACT) in Chronic Kidney Disease and Congenital Anomalies of Kidney and Urinary Tract, sponsored by Prokidney. Completed at 5 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Prokidney · Phase 1, Interventional, and Treatment
A phase 1, open-label safety, tolerability and early efficacy study of a Renal Autologous Cell Therapy (REACT) in patients with Chronic Kidney Disease from Congenital Anomalies of the Kidney and Urinary Tract (CAKUT) (REGEN-004)
It is anticipated that all subjects will receive two planned Renal Autologous Cell Therapy (REACT) injections to allow dose-finding and evaluate the duration of effects. The scientific rationale, based on non-clinical studies, is that the biologically active component of REACT (homologous, autologous, SRC) delays progression of experimental models of Chronic Kidney Disease (CKD) by augmenting renal structure and function. As a result, the more cells that can be infused, the greater the potential improvement in renal function.
3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.
This study's enrollment of 6 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.
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Exclusion Criteria:
The volume of REACT to be administered will be determined by pre-procedure MRI volumetric 3D evaluation or ellipsoid formula. The participant will receive a second injection 6 months after the first injection into the same kidney.
Biological: Renal Autologous Cell Therapy (REACT)
Autologous selected renal cells (SRC)
Assess change in eGFR and observe incidence of renal-specific procedure and/or product related adverse events (AEs) through 18 months following two Renal Autologous Cell Therapy (REACT) injections [Safety].
The primary objective is to assess the safety and optimal delivery of Renal Autologous Cell Therapy (REACT) injected at one site in a recipient kidney as measured by procedure- and/or product related adverse events (AEs) through 18 months post-treatment.
Time frame: 18 months following last REACT injection
Number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT).
The number of subjects with renal-specific adverse events over a 18-month period following injection of Renal Autologous Cell Therapy (REACT) will be observed utilizing renal-specific laboratory assessments.
Time frame: 18 months following last REACT injection
Plan to share: No
This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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