Clinical trial NCT06790498: Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product
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)
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Diabetic Kidney Disease
Chronic Kidney Disease
Lead sponsor: Prokidney
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 50
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Chronic Kidney Disease

Brief summary: 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.

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

Primary outcomes:
measure: Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies.
timeFrame: 60 months from completion of parent protocol EOS Visit
Secondary outcomes:
measure: Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: Time from first injection to chronic dialysis.
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: Time from first injection to renal transplant
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: Time from first injection to a cardiovascular death.
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: Time from first injection to a renal death.
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: 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.
timeFrame: 60 months from completion of parent protocol EOS Visit
measure: 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.
timeFrame: 60 months from completion of parent protocol EOS Visit
Other outcomes:
Locations:
city: Meridian
country: United States
facility: Boise Kidney & Hypertension Institute
state: Idaho
Study officials:
affiliation: Prokidney
name: Study Director
role: STUDY_DIRECTOR
References: