A Study of REGEND003 on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)

Официальное название

An Exploratory Study of REGEND003 Kidney Progenitor Cells on Patients With Type 2 Diabetes Mellitus (T2DM) and Chronic Kidney Disease (CKD)

Обзор

REGEND003, which consists of human kidney progenitor cells, demonstrates promising potential in repairing kidney injury. The purpose of this study is to assess the saftey and tolerability of REGEND003 on patients with Type 2 Diabetes Mellitus and Chronic Kidney Disease. It is an exploratory study with multi-centered, randomized, controlled, single-blinded, dose-escalated designs.

Вмешательства

• Биопрепарат REGEND003
  REGEND003
• Другое Placebo
  Placebo

Первичные конечные точки

• Adverse Event (AE) associated with the Cell Therapy [Срок оценки: Within 24 weeks post-treatment]

Вторичные конечные точки (11)

• Complications associated with Intrarenal Injection [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Concentration of C-Reactive Protein [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Glomerular Filtration Rate (GFR) [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Concentration of Serum Creatinine [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in 24-Hour Urinary Protein Excretion [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Urine Albumin-Creatinine Ratio (uACR) [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Kidney Volume [Срок оценки: Winthin 24 weeks post-treatment]
• Change from Baseline in Renal Cortical Thickness (RCT) [Срок оценки: Within 24 weeks post-treatment]
• Changes from Baseline in the Outcomes from Kidney Disease Quality of Life (KDQOL) Survey [Срок оценки: Within 24 weeks post-treatment]
• Change from Baseline in Blood Pressure [Срок оценки: Within 24 weeks post-treatment]
• Time from Injection to First Kidney Disease Progression (KDP) [Срок оценки: Within 24 weekd post-treatment]

Критерии участия

Критерии включения

• Male or female, aged 30 to 75 years at the time of signing the informed consent form;
• Diagnosed with Type 2 Diabetes Mellitus for at least 1 year;
• Diagnosed with Chronic Kidney Disease (CKD);
• Voluntarily sign the informed consent form, be able to cooperate in completing study-related procedures and examinations, capable of adequately recording or describing changes in their condition, and demonstrate strong compliance.

Критерии исключения

• Females who are pregnant, nursing, or planning to be pregnant within a year after using this product (or males whose spouse planning to be pregnant);
• At the time of screening, subject who is positive in each of treponema pallidum antibody (TP-Ab), human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody test.

Hepatitis B virus carriers with stable current condition can be enrolled. Cured hepatitis C patients with negative result in HCV ribonucleic acid (RNA) test can be enrolled as well.

• Presence of a current or prior history of malignant tumor at screening (with the exception of those with disease-free survival for more than 2 years, or malignancies deemed to be of low aggressiveness as assessed by the investigator).
• Patients with Type 1 Diabetes Mellitus;
• Patients undergoing regular hemodialysis or peritoneal dialysis;
• Presence of severe acute complications of diabetes or CKD requiring hospitalization within 2 weeks prior to screening;
• Presence of more than one episode of hypoglycemic coma (blood glucose ≤3.9 mmol/L) within 1 month prior to screening;
• Patients intolerant to renal puncture/intrarenal injection procedures;
• Patients with diagnosis of acute kidney injury, congenital or hereditary kidney diseases, renal atrophy, or other renal conditions deemed ineligible by the investigator, as well as patients with a history of kidney transplantation at screening;
• Presence of severe systemic diseases within 6 months prior to screening and judged by the investigator as unsuitable for the study;
• Patients requiring long-term anticoagulant or antiplatelet therapy who, in the investigator's judgment, cannot discontinue medication 1 week prior to renal puncture/intrarenal injection procedures;
• Patients with suicidal risk, history of psychiatric disorders, or history of epilepsy at screening;
• Patients with severe arrhythmias or heart conduction disorders (degree II or above) in 12-lead ECG test at screening;
• Patients participated in other clinical trials with interventions within 1 month prior to screening;
• Subject with assessed survival time of less than 1 year by investigators at screening;
• Investigators, co-investigators, study coordinators, employees of participating investigators or research centers, or family members of the above individuals;
• Any condition that, in the investigator's judgment, may increase subject risk or interfere with the clinical trial.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shanghai Tongji Hospital — Шанхай

Идентификаторы

NCT: NCT07275788 · REGEND003-CKD-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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