NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 156
- 试验地点
- 2
- 主要终点
- The primary endpoint is the change from baseline in UACR over the 6-month intervention period.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The study is double-blind in that the study participants and the study staff involved in outcomes assessments will be unaware of the intervention assignment. The randomization schedule will be masked from all study personnel except those specifically designated below.
- The unblinded study biostatistician
- The staff of the Investigational Drug Pharmacy Services.
- The DSMB, if requested
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Investigational Product - MIB 626
The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.
干预措施: Investigational Product - MIB 626 (Drug)
Placebo
Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.
干预措施: Placebo (Drug)
结局指标
主要结局
The primary endpoint is the change from baseline in UACR over the 6-month intervention period.
时间窗: 6 months
To determine whether treatment with a microcrystalline formulation of β nicotinamide mononucleotide (βNMN) in older adults with DKD improves urinary albumin to creatinine excretion ratio (UACR), compared to placebo.
次要结局
- To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance.(6 month)
- To determine whether NMN alters the circulating biomarkers of aging that the geroscience experts have recommended.(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.(6 months)
- Assess the proportion of participants in the two study arms with 30% or greater reduction in UACR(6 months)
- Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury.(6 month)
- Change from baseline in the levels of serum creatinine over 6-month intervention period(6 month)
- Change from baseline in the levels of cystine C over 6-month intervention period.(6 month)
- Assess the change from baseline in performance-based measures of function.(6 month)
- Assess the change in measure of H1bac as a measure of glycemic control over the 6 months intervention period.(6 months)
- Assess the change in measure of fasting glucose as a measure of glycemic control over the 6 months intervention period.(6 months)
研究者
Shalendar Bhasin, MD
Principal Investigator, Professor of Medicine, Harvard Medical School Director, Research Program in Men's Health: Aging and Metabolism Co-Director, BWH Center for Transgender Health Director, Boston Claude D. Pepper Older Americans Independence Center
Brigham and Women's Hospital