NAD Augmentation in Diabetes Kidney Disease
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
🗓️ Study Start (Actual) 13 April 2023
🗓️ Primary Completion (Estimated) 31 December 2025
✅ Study Completion (Estimated) 1 July 2026
👥 Enrollment (Estimated) 140
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE2
Locations:
📍 Boston, Massachusetts, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • 1. Has T2DM, as indicated by any of the following:
    • 1. Self-report of diabetes plus the use of a prescribed diabetes medication.
    • 2. ICD-10 code for diabetes plus current use of a diabetes medication in the electronic medical record.
    • 3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
    • 2. Fasting morning UACR between 100 and 2,000 mg/g creatinine on two separate days
    • 3. If UACR is \> 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB
    • 4. eGFR \> 30 mL/ min / 1.73 m2
    • 5. Hemoglobin A1c \<9%
    • 6. Able to speak English or Spanish
    • 7. Willing and able to provide written informed consent
    • 8. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months

    Exclusion Criteria:

    • 1. Fasting morning UACR \> 2,000 mg/ g creatinine
    • 2. Other laboratory abnormalities:
    • 1. Has AST or ALT \> 3 times the upper limit of normal
    • 2. creatinine \> 2.5 mg/dL
    • 3. Hematocrit \< 0.34 or 0.50 L/L
    • 3. A major adverse cardiovascular event in preceding 3 months
    • 4. Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
    • 5. Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety.
    • 6. History of alcohol or substance use disorder or dependence (DSM 5 criteria) within the last 2 years.
    • 7. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
    • 8. BMI \> 42.5 kg/ m2
Ages Eligible for Study: 60 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 9 January 2023
  • First Submitted that Met QC Criteria 6 March 2023
  • First Posted 8 March 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 21 April 2023
  • Last Update Posted 25 April 2023
  • Last Verified April 2023