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RECRUITINGPhase 2INTERVENTIONAL

NAD Augmentation in Diabetes Kidney Disease

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form 8. In addition, female participants must Not be pregnant and not planning to become pregnant over the next 6 months Who Should NOT Join This Trial: 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

DRUG

Investigational Product - MIB 626

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.

DRUG

Placebo

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

Locations (1)

Brigham and Women's Hospital
Boston, Massachusetts, United States