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Enrolling by Invitation

NCT Number: NCT06790498

Long-Term Follow-up Study of Participants Exposed to Renal Autologous Cell Therapy Frozen Product

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.

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Key information

Conditions

Diabetic Kidney Disease Chronic Disease Chronic Kidney Disease Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Disease Attributes Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

30 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Boise Kidney & Hypertension Institute

Meridian, Idaho, 83642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renal Autologous Cell Therapy (REACT)

Biological

No interventions in this trial

Primary outcomes

  1. 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

    Evaluation of the long-term safety of REACT will be assessed via:

    • Incidence of delayed serious adverse events (SAEs) obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
    • Incidence of delayed biopsy-related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
    • Incidence of delayed injection procedure related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.
    • Incidence of delayed investigational product related SAEs obtained throughout long-term follow-up after completing their enrollment in the investigational clinical studies.

Secondary outcomes

  1. 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 eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation.

  2. Time from first injection to chronic dialysis.

    Time frame: 60 months from completion of parent protocol EOS Visit

    Time from first injection to chronic dialysis

  3. Time from first injection to renal transplant

    Time frame: 60 months from completion of parent protocol EOS Visit

    Time from first injection to renal transplant

  4. 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 cardiovascular death.

  5. Time from first injection to a renal death.

    Time frame: 60 months from completion of parent protocol EOS Visit

    Time from first injection to a renal death.

  6. 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 5-year risk of end stage renal

  7. 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

    Percent of participants who have the same or reduced 2-year risk of end stage renal

Sponsors and collaborators

Lead sponsor

Prokidney

Industry

Registry information

Official study 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)

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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