NAD Augmentation in Diabetes Kidney Disease

Официальное название

NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial

Обзор

A phase 2a trial randomized, double-blind, placebo-controlled, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.

Подробное описание

This will be two centers, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.

The trial will enroll community-dwelling older adults, 60 years or older, with type 2 diabetes mellitus (T2DM) and urine albumin to creatinine excretion ratio \> 100 mg/ g creatinine.

Вмешательства

• Препарат Investigational Product - MIB 626
  The eligible participants will be assigned to receive either NMN or placebo using concealed block randomization in a 1:1 ratio, stratified by sex (male, female), age (60 to 75, \>75 years) and trial site. The randomization list will be generated by the unblinded biostatistician using the software R (www.r-project.org), and deployed in a secure, centralized web-based application accessible to study staff following confirmation of a participant's eligibility.
• Препарат Placebo
  Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Первичные конечные точки

• The primary endpoint is the change from baseline in UACR over the 6-month intervention period. [Срок оценки: 6 months]

Вторичные конечные точки (10)

• Assess the proportion of participants in the two study arms with 30% or greater reduction in UACR [Срок оценки: 6 months]
• Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury. [Срок оценки: 6 month]
• Change from baseline in the levels of serum creatinine over 6-month intervention period [Срок оценки: 6 month]
• Change from baseline in the levels of cystine C over 6-month intervention period. [Срок оценки: 6 month]
• To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance. [Срок оценки: 6 month]
• Assess the change from baseline in performance-based measures of function. [Срок оценки: 6 month]
• To determine whether NMN alters the circulating biomarkers of aging that the geroscience experts have recommended. [Срок оценки: 6 months]
• Assess the change from baseline in the levels of NMN in the peripheral blood and in the PBMCs using a validated LC-MS/MS assay. [Срок оценки: 6 months]
• Assess the change in measure of H1bac as a measure of glycemic control over the 6 months intervention period. [Срок оценки: 6 months]
• Assess the change in measure of fasting glucose as a measure of glycemic control over the 6 months intervention period. [Срок оценки: 6 months]

Критерии участия

Критерии включения

• A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH > 20 U/L), 30 years or older
• Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:

• Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
• ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
• HbA1c >6.4%; or 2 fasting glucose > 125 mg/dL
• Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.

a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.

• If type 2 diabetic and UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
• eGFR > 25 mL/ min / 1.73 m2
• Hemoglobin A1c <10%
• Able to speak English or Spanish or Haitian Creole
• Willing and able to provide written informed consent
• In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months.

Критерии исключения

• Fasting morning UACR > 5,000 mg/ g creatinine
• Other laboratory abnormalities:

• Has AST or ALT > 3 times the upper limit of normal
• eGFR < 25 mL/ min / 1.73 m2
• Hematocrit < 0.34 or > 0.50 L/L
• A major adverse cardiovascular event in preceding 3 months
• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
• Current alcohol or substance use disorder or dependence (DSM 5 criteria).
• Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
• An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
• Has a history of anaphylaxis from vitamin B3 derivatives
• BMI > 42.5 kg/ m2
• If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Brigham and Women's Hospital — Boston

Идентификаторы

NCT: NCT05759468 · 2021P003702

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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