NAD Augmentation in Diabetes Kidney Disease

NCT ID: NCT05759468

Last Updated: 2025-09-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-13
• Study Completion Date: 2026-07-01

Brief 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.

Detailed Description

This will be two centers, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.

The trial will enroll community-dwelling older adults, 60 years or older, with type 2 diabetes mellitus (T2DM) and urine albumin to creatinine excretion ratio > 100 mg/ g creatinine.

Conditions

Type2diabetes; Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Investigational Product - MIB 626

The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily.

Group Type: ACTIVE_COMPARATOR

Investigational Product - MIB 626

Intervention Type: DRUG

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

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.

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

NMN; Placebo for NMN

Eligibility Criteria

Inclusion 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

Exclusion Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Shalendar Bhasin, MD

Principal Investigator, Professor of Medicine, Harvard Medical School Director, Research Program in Men's Health: Aging and Metabolism Co-Director, BWH Center for Transgender Health Director, Boston Claude D. Pepper Older Americans Independence Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shalender Bhasin, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Shalender Bhasin, MD

Role: CONTACT

sbhasin@bwh.harvard.edu

6175259150

Nancy Latham, PhD

Role: CONTACT

nklatham@bwh.harvard.edu

6179999195

Facility Contacts

Nancy K Latham, PhD

Role: primary

nklatham@bwh.harvard.edu

6179999195

Other Identifiers

2021P003702

Identifier Type: -

Identifier Source: org_study_id