A Long-Term Follow-Up Study of Participants Exposed to REACT
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age30-80
SponsorProkidney
About this trial
The purpose of this study is to evaluate the long-term safety of up to two gelatin-hydrogel formulation REACT injections given 3 to 6 months apart and delivered percutaneously into same kidney on renal function in participants with chronic kidney disease (CKD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant must have received gelatin-hydrogel formulation REACT in a previous trial (RMCL-002, REGEN-003, REGEN-004) for the treatment of chronic kidney disease and completed an end of study visit in their parent trial per protocol.
Disqualifiers
The participant did not receive REACT in a previous trial for the treatment of chronic kidney disease.
Trial population
patients with CKD
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Renal Autologous Cell Therapy (REACT)
Biological/VaccineNo interventions in this trial
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: CKD patients previously treated with REACT1 intervention
Trial outcomes
Primary outcomes
1
Primary Endpoint: Long-term safety of REACT
Evaluation of the long-term safety of REACT will be assessed via: 1. Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 2. Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 3. Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies. 4. Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
Time frame
60 months from completion of parent protocol EOS VisitSecondary outcomes
1
First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m²
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 Visit2
Second Secondary Endpoint: Time from first injection to chronic dialysis.
Time from first injection to chronic dialysis.
Time frame
60 months from completion of parent protocol EOS Visit3
Third Secondary Endpoint: Time from first injection to renal transplant.
Time from first injection to renal transplant.
Time frame
60 months from completion of parent protocol EOS Visit Source ClinicalTrials.gov