RecruitingPhase 2NCT05759468

NAD Augmentation in Diabetes Kidney Disease

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


Sponsor

Brigham and Women's Hospital

Enrollment

156 participants

Start Date

Apr 13, 2023

Study Type

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

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether boosting levels of NAD (a natural molecule involved in cell energy and repair) can help protect the kidneys in people with type 2 diabetes who already have kidney damage. NAD levels drop in kidney disease, and this study tests if raising them slows the decline. **You may be eligible if...** - You have type 2 diabetes (confirmed by records, blood tests, or medications) - Your urine tests show a moderate to high amount of protein — a sign of kidney damage - Your kidney function (eGFR) is above 30 - Your blood sugar control is not extremely poor (HbA1c under 9%) - You speak English or Spanish **You may NOT be eligible if...** - You have severe kidney disease (eGFR under 30) - You have type 1 diabetes or certain other hormonal conditions - You have active cancer or serious liver disease - You are pregnant or planning to become pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGInvestigational 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.

DRUGPlacebo

Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.


Locations(1)

Brigham and Women's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

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NCT05759468


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