NCT05759468 · Brigham and Women's Hospital
NAD Augmentation in Diabetes Kidney Disease
(DKD)
What this study is about
A phase 2a trial randomly assigned, where neither patients nor doctors know which treatment is given, compared against an inactive treatment, parallel group trial to determine whether NMN administration improves DKD, as indicated by a significantly greater reduction in UACR compared with placebo administration.
View original scientific description
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.
Interventions
DRUG
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.
DRUG
Placebo
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.
Primary outcome measures
The primary endpoint is the change from baseline in UACR over the 6-month intervention period.
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Boston, Massachusetts
Collaborators
Boston Medical Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 13, 2026 · Source of record for eligibility and locations