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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: f
View:

• Has T2DM, as indicated by any of the following:

‣ Self-report of diabetes plus the use of a prescribed diabetes medication.

⁃ ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.

⁃ HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL

• Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days

• If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB

• eGFR \> 30 mL/ min / 1.73 m2

• Hemoglobin A1c \<9%

• Able to speak English or Spanish

• 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

Locations
United States
Massachusetts
Brigham and Women's Hospital
RECRUITING
Boston
Contact Information
Primary
Shalender Bhasin, MD
sbhasin@bwh.harvard.edu
6175259150
Backup
Nancy Latham, PhD
nklatham@bwh.harvard.edu
6179999195
Time Frame
Start Date: 2023-04-13
Estimated Completion Date: 2026-07-01
Participants
Target number of participants: 140
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Brigham and Women's Hospital
Collaborators: Boston Medical Center

This content was sourced from clinicaltrials.gov