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DKDNCT05759468

NAD Augmentation in Diabetes Kidney Disease

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 5 versions: 5 with changes below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 128 words
    • Enrollment increased: 140 → 156 participants
    v5
  2. Primary completion date: Dec 31, 2025 to Nov 30, 2026
    • Study completion date: Jul 1, 2026 to Mar 31, 2027
    v4
  3. Site contact updatedv3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 1, 2023 to Apr 13, 2023
    v2
  5. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

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

Secondary (10)

Assess the proportion of participants in the two study arms with 30% or greater reduction in UACR
Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury.
Change from baseline in the levels of serum creatinine over 6-month intervention period
Change from baseline in the levels of cystine C over 6-month intervention period.
To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance.
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Assess the change from baseline in performance-based measures of function.
To determine whether NMN alters the circulating biomarkers of aging that the geroscience experts have recommended.
Assess the change from baseline in the levels of NMN in the peripheral blood and in the PBMCs using a validated LC-MS/MS assay.
Assess the change in measure of H1bac as a measure of glycemic control over the 6 months intervention period.
Assess the change in measure of fasting glucose as a measure of glycemic control over the 6 months intervention period.

Arms and interventions

Investigational Product - MIB 626Active 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.

PlaceboPlacebo comparator

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

Drugs: Investigational Product - MIB 626, Placebo

Sites

1 site in 1 country

  • Brigham and Women's HospitalBoston, Massachusetts, United States