NAD Augmentation in Diabetes Kidney Disease

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Brigham and Women's Hospital
Study ID
NCT05759468
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diabetic Kidney Disease
  • Type2diabetes

Eligibility Criteria

Sex
ALL
Age
30 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

First listed
Mar 8, 2023
Start date
Apr 13, 2023
Status verified
Feb 2026
Primary completion
Nov 30, 2026
Completion
Mar 31, 2027

Study Design

Enrollment
156 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Placebo Comparator: Placebo
    Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Primary Outcome Measure

The primary endpoint is the change from baseline in UACR over the 6-month intervention period. [ Time Frame: 6 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115
Nancy K Latham, PhD
[email protected]
6179999195
Shalender Bhasin, MB BS (PRINCIPAL_INVESTIGATOR)
Nancy Latham, PhD (SUB_INVESTIGATOR)

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