Health TrialsbyHealthPanel

NAD Augmentation in Diabetes Kidney Disease

ConditionsType2diabetesDiabetic Kidney Disease
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age30+
SponsorBrigham and Women's Hospital

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

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

Disqualifiers

Fasting morning UACR > 5,000 mg/ g creatinine

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

156 Participants
are divided into 2 treatment groups
Group A: Investigational Product - MIB 626Active comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
6 months

Secondary outcomes

1

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

In supportive analysis of the primary outcome, the investigator will compare the proportion of participants in the two study arms with 30% or greater reduction in UACR

Time frame
6 months
2

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

Compared to placebo treatment, NMN treatment of older adults with DKD will assess for improvements in biomarkers of kidney injury in association with DKD prognosis by measuring KIM-1 and STNFR1 combinedly.

Time frame
6 month
3

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

To determine whether NMN treatment is associated with change in serum creatinine from baseline to 24 weeks between the two study arms.

Time frame
6 month
4

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

To determine whether NMN treatment is associated with change in cystatin C from baseline to 24 weeks between the two study arms.

Time frame
6 month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Boston Medical Center

Collaborator

Source ClinicalTrials.gov
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