Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Renal Autologous Cell Therapy (REACT).
- Who it may be relevant to
- Registry conditions: Diabetic Kidney Disease, Chronic Kidney Disease. Basic parameters: 30 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies REGEN-006, REGEN-007, and REGEN-015 (REGEN-008S2)
Overview
The purpose of this study is to evaluate the long-term safety, efficacy, and durability in participants with chronic kidney disease (CKD) who received up to four REACT injections, delivered percutaneously into either the same or bilateral kidneys in previous studies.
Detailed description
This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 50 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (REGEN-007, REGEN-006, REGEN-015) will be monitored for up to five years with alternating in clinic and phone visits.
Interventions
- Biological Renal Autologous Cell Therapy (REACT)
No interventions in this trial
Primary outcome measures
- Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. [Time frame: 60 months from completion of parent protocol EOS Visit]
Secondary outcome measures (7)
- Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. [Time frame: 60 months from completion of parent protocol EOS Visit]
- Time from first injection to chronic dialysis. [Time frame: 60 months from completion of parent protocol EOS Visit]
- Time from first injection to renal transplant [Time frame: 60 months from completion of parent protocol EOS Visit]
- Time from first injection to a cardiovascular death. [Time frame: 60 months from completion of parent protocol EOS Visit]
- Time from first injection to a renal death. [Time frame: 60 months from completion of parent protocol EOS Visit]
- Percent of participants who have the same or reduced 5-year risk of end stage renal disease (ESRD) at Months 12, 24, 36, 48, and 60. [Time frame: 60 months from completion of parent protocol EOS Visit]
- Percent of participants who have the same or reduced 2-year risk of end stage renal disease at Months 12, 24, 36, 48, and 60. [Time frame: 60 months from completion of parent protocol EOS Visit]
Eligibility criteria
Inclusion criteria
- The participant must have received REACT in a previous trial (REGEN-006, REGEN- 007, and REGEN-015) for the treatment of chronic kidney disease and completed an end of study visit in their previous trial per protocol.
- The participant is willing and able to cooperate with all aspects of the protocol.
- The participant is willing and able to provide signed informed consent.
Exclusion criteria
- Participant did not receive REACT in a previous trial for the treatment of chronic kidney disease
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boise Kidney & Hypertension Institute — Meridian
Identifiers
NCT: NCT06790498 · REGEN-008S2