NAD Augmentation in Diabetes Kidney Disease
NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial
Brigham and Women's Hospital
140 participants
Apr 13, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- Has T2DM, as indicated by any of the following:
- Self-report of diabetes plus the use of a prescribed diabetes medication.
- ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.
- HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
- Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days
- If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB
- eGFR \> 30 mL/ min / 1.73 m2
- Hemoglobin A1c \<9%
- Able to speak English or Spanish
- 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 Criteria11
- Fasting morning UACR \> 2,000 mg/ g creatinine
- Other laboratory abnormalities:
- Has AST or ALT \> 3 times the upper limit of normal
- creatinine \> 2.5 mg/dL
- 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
- Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety.
- History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years.
- Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
- BMI \> 42.5 kg/ m2
Interventions
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.
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05759468