NAD Augmentation in Diabetes Kidney Disease

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.

Conditions

Type2diabetes, Diabetic Kidney Disease

Study Overview

Study Details

Study overview

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.

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

NAD Augmentation in Diabetes Kidney Disease

Condition
Type2diabetes
Intervention / Treatment

-

Contacts and Locations

Boston

Brigham and Women's Hospital, Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Has T2DM, as indicated by any of the following:
  • 1. Self-report of diabetes plus the use of a prescribed diabetes medication.
  • 2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.
  • 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
  • 2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days
  • 3. If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB
  • 4. eGFR \> 30 mL/ min / 1.73 m2
  • 5. Hemoglobin A1c \<9%
  • 6. Able to speak English or Spanish
  • 7. Willing and able to provide written informed consent
  • 8. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months
  • 1. Fasting morning UACR \> 2,000 mg/ g creatinine
  • 2. Other laboratory abnormalities:
  • 1. Has AST or ALT \> 3 times the upper limit of normal
  • 2. creatinine \> 2.5 mg/dL
  • 3. Hematocrit \< 0.34 or 0.50 L/L
  • 3. A major adverse cardiovascular event in preceding 3 months
  • 4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
  • 5. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety.
  • 6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years.
  • 7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
  • 8. BMI \> 42.5 kg/ m2

Ages Eligible for Study

60 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Brigham and Women's Hospital,

Shalender Bhasin, MD, PRINCIPAL_INVESTIGATOR, Brigham and Women's Hospital

Study Record Dates

2026-07-01