NAD Augmentation in Diabetes Kidney Disease

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Type2diabetes, Diabetic Kidney Disease

In brief

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.

Key facts

Study ID

NCT05759468

Run by

Brigham and Women's Hospital

People needed

156

Starts

2023-04-13

Expected to finish

2027-03-31

Last updated by the study team

2026-04-13

Who can join

Age: 30 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:
• 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
• Has an average of two or more morning UACR equal to or above 100mg/g creatinine each of which must be equal to or greater than 60 mg / g creatinine with at least one UACR value measured during the screening visit.
• a. Recent UACR value in the medical record within the preceding 3 months prior to screening is acceptable.
• If type 2 diabetic and UACR is > 300 mg/g creatinine, must be currently using an ACE inhibitor or an ARB or a SGLT2 inhibitor.
• eGFR > 25 mL/ min / 1.73 m2
• Hemoglobin A1c <10%
• Able to speak English or Spanish or Haitian Creole
• 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.

You may not qualify if…

• Fasting morning UACR > 5,000 mg/ g creatinine
• Other laboratory abnormalities:
• 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
• A major adverse cardiovascular event in preceding 3 months
• Participation in an investigational trial to evaluate pharmaceuticals or biologics within the past 3 months or 5 half-lives, whichever is shorter
• Current alcohol or substance use disorder or dependence (DSM 5 criteria).
• Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
• An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
• Has a history of anaphylaxis from vitamin B3 derivatives
• BMI > 42.5 kg/ m2
• If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.

Where it is running

• Brigham and Women's Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.