Actively Recruiting

Phase 2
Age: 30Years +
All Genders
NCT05759468

NAD Augmentation in Diabetes Kidney Disease

Led by Brigham and Women's Hospital · Updated on 2026-04-13

156

Participants Needed

1

Research Sites

206 weeks

Total Duration

On this page

Sponsors

B

Brigham and Women's Hospital

Lead Sponsor

B

Boston Medical Center

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

NAD Augmentation in Diabetes Kidney Disease

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Be a man or postmenopausal woman aged 30 years or older
  • Have type 1 or type 2 diabetes confirmed by medication use, medical records, HbA1c >6.4%, or fasting glucose >125 mg/dL
  • Have two or more morning UACR measurements equal to or above 100 mg/g creatinine, with at least one measured at screening
  • If type 2 diabetic with UACR > 300 mg/g creatinine, currently be using an ACE inhibitor, ARB, or SGLT2 inhibitor
  • Have an estimated glomerular filtration rate (eGFR) above 25 mL/min/1.73 m2
  • Have hemoglobin A1c less than 10%
  • Be able to speak English, Spanish, or Haitian Creole
  • Be willing and able to provide written informed consent
  • Female participants must not be pregnant or planning to become pregnant in the next 6 months
Not Eligible

You will not qualify if you...

  • Have fasting morning UACR greater than 5,000 mg/g creatinine
  • Have liver enzyme (AST or ALT) levels more than 3 times the upper limit of normal
  • Have eGFR less than 25 mL/min/1.73 m2
  • Have hematocrit less than 0.34 or greater than 0.50 L/L
  • Have had a major adverse cardiovascular event in the past 3 months
  • Have participated in another drug or biologic trial in the past 3 months or 5 half-lives, whichever is shorter
  • Have current alcohol or substance use disorder or dependence
  • Have major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms interfering with study procedures
  • Have had an acute illness, including COVID-19, requiring hospitalization in the past 3 months or any acute illness in the past month
  • Have a history of anaphylaxis from vitamin B3 derivatives
  • Have a body mass index (BMI) over 42.5 kg/m2
  • Have a confirmed diagnosis of type 3 diabetes or gestational diabetes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

S

Shalender Bhasin, MD

CONTACT

N

Nancy Latham, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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