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Recruiting NCT05918523

A Long-Term Follow-Up Study of Participants Exposed to REACT

— Observational Diabetic Kidney Disease Chronic Kidney Diseases

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 Diseases. 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 →

Unsure about the terms? Read our patient guide →

Official title

A Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy From Studies RMCL-002, REGEN-003, REGEN-004

Overview

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).

Detailed description

This observational extension study is a multi-center, prospective, non-therapeutic study, where up to 80 participants who have been enrolled and dosed with Renal Autologous Cell Therapy in previous interventional clinical studies (RMCL-002, REGEN-003, REGEN-004) 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

  • Primary Endpoint: Long-term safety of REACT [Time frame: 60 months from completion of parent protocol EOS Visit]
Secondary outcome measures (3)
  • First Secondary Endpoint: Time from first injection to eGFR <15 mL/min/1.73m² [Time frame: 60 months from completion of parent protocol EOS Visit]
  • Second Secondary Endpoint: Time from first injection to chronic dialysis. [Time frame: 60 months from completion of parent protocol EOS Visit]
  • Third Secondary Endpoint: Time from first injection to renal transplant. [Time frame: 60 months from completion of parent protocol EOS Visit]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • The 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: NCT05918523 · REGEN-008S1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗