NAD Augmentation in Diabetes Kidney Disease

NCT05759468 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2021P003702
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2diabetes; Diabetic Kidney Disease

Keywords

diabetes; type 2 diabetes; kidney disease

Outcome Measures

Primary Outcomes (1)

• The primary endpoint is the change from baseline in UACR over the 6-month intervention period.

  To determine whether treatment with a microcrystalline formulation of β nicotinamide mononucleotide (βNMN) in older adults with DKD improves urinary albumin to creatinine excretion ratio (UACR), compared to placebo.

  6 months

Secondary Outcomes (10)

• Assess the proportion of participants in the two study arms with 30% or greater reduction in UACR

  6 months

• Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury.

  6 month

• Change from baseline in the levels of serum creatinine over 6-month intervention period

  6 month

• Change from baseline in the levels of cystine C over 6-month intervention period.

  6 month

• To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance.

  6 month

Study Arms (2)

Investigational Product - MIB 626

ACTIVE COMPARATOR

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.

Drug: Investigational Product - MIB 626

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Investigational Product - MIB 626 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.

Also known as: NMN

Investigational Product - MIB 626

Placebo DRUG

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

Also known as: Placebo for NMN

Placebo

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A man or a postmenopausal woman (complete cessation of menses for one or more years and /or FSH \> 20 U/L), 30 years or older
• Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:
• Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
• ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
• HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
• Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.
• a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.
• If type 2 diabetic and UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
• eGFR \> 25 mL/ min / 1.73 m2
• Hemoglobin A1c \<10%
• Able to speak English or Spanish or Haitian Creole
• 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.

You may not qualify if:

• Fasting morning UACR \> 5,000 mg/ g creatinine
• Other laboratory abnormalities:
• Has AST or ALT \> 3 times the upper limit of normal
• eGFR \< 25 mL/ min / 1.73 m2
• 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
• Current alcohol or substance use disorder or dependence (DSM 5 criteria).
• Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
• An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
• Has a history of anaphylaxis from vitamin B3 derivatives
• BMI \> 42.5 kg/ m2
• If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.

Sponsors & Collaborators

• Boston Medical Center: collaborator
• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

Diabetic Nephropathies; Diabetes Mellitus; Diabetes Mellitus, Type 2; Kidney Diseases

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Shalender Bhasin, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shalender Bhasin, MD

CONTACT

6175259150; sbhasin@bwh.harvard.edu

Nancy Latham, PhD

CONTACT

6179999195; nklatham@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind in that the study participants and the study staff involved in outcomes assessments will be unaware of the intervention assignment. The randomization schedule will be masked from all study personnel except those specifically designated below. 1. The unblinded study biostatistician 2. The staff of the Investigational Drug Pharmacy Services. 3. The DSMB, if requested
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: 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

Model Details: This will be three center, 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.

Study Record Dates

• First Submitted: January 9, 2023
• First Posted: March 8, 2023
• Study Start: April 13, 2023
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)