Набор по приглашению NCT06790498

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

— Наблюдательное Diabetic Kidney Disease Chronic Kidney Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Renal Autologous Cell Therapy (REACT).
Кому может быть актуально: Состояния в реестре: Diabetic Kidney Disease, Chronic Kidney Disease. Базовые параметры: 30 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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)

Обзор

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.

Подробное описание

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.

Вмешательства

Биопрепарат Renal Autologous Cell Therapy (REACT)
No interventions in this trial

Первичные конечные точки

Long-term safety of REACT follow-up after completing their enrollment in the investigational clinical studies. [Срок оценки: 60 months from completion of parent protocol EOS Visit]

Вторичные конечные точки (7)

Time from first injection to eGFR <15 mL/min/1.73m² using the 2009 CKD-EPI serum creatinine equation. [Срок оценки: 60 months from completion of parent protocol EOS Visit]
Time from first injection to chronic dialysis. [Срок оценки: 60 months from completion of parent protocol EOS Visit]
Time from first injection to renal transplant [Срок оценки: 60 months from completion of parent protocol EOS Visit]
Time from first injection to a cardiovascular death. [Срок оценки: 60 months from completion of parent protocol EOS Visit]
Time from first injection to a renal death. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 60 months from completion of parent protocol EOS Visit]

Критерии участия

Критерии включения

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.