Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 and older
Sex
Any
Trial phase
Phase 2
Study type
Interventional
Purpose
Treatment
Participants needed
156 (estimated)
Sponsor
Brigham and Women's Hospital · Other
Who this trial is looking for
This trial is looking for adults with type 2 diabetes and kidney issues. Participants will take either NMN or a placebo for a study on kidney health.
Are You a Good Fit for This Trial?
Must be takingACE inhibitorARBSGLT2 inhibitor
Rules you outType 1 diabetesGestational diabetes
You may be able to join if
I am 30 years or older
I have type 2 diabetes
I have high morning UACR levels
I use an ACE inhibitor or ARB or SGLT2 inhibitor if my UACR is high
My eGFR is above 25
My HbA1c is below 10%
I can speak English, Spanish, or Haitian Creole
I agree to provide written consent
You may not be able to join if
I have very high UACR levels
I have liver issues with AST or ALT levels high
My eGFR is below 25
I have had a major heart event in the last 3 months
I have a substance use disorder
I have serious mental health issues that affect participation
I have been hospitalized for an acute illness in the last 3 months
I have a history of severe allergic reactions to vitamin B3
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
Inclusion Criteria:
1. 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
2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:
1. Self-report of type 1 or type 2 diabetes plus the use of a pre…
Inclusion Criteria:
1. 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
2. Has type 1 or type 2 diabetes mellitus, as indicated by any of the following:
1. Self-report of type 1 or type 2 diabetes plus the use of a prescribed medication.
2. ICD-10 code for type 1 or type 2 diabetes plus current use of a medication in the electronic medical record.
3. HbA1c \>6.4%; or 2 fasting glucose \> 125 mg/dL
3. 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.
4. 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.
5. eGFR \> 25 mL/ min / 1.73 m2
6. Hemoglobin A1c \<10%
7. Able to speak English or Spanish or Haitian Creole
8. Willing and able to provide written informed consent
9. 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 \> 5,000 mg/ g creatinine
2. Other laboratory abnormalities:
1. Has AST or ALT \> 3 times the upper limit of normal
2. eGFR \< 25 mL/ min / 1.73 m2
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. Current alcohol or substance use disorder or dependence (DSM 5 criteria).
6. Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures.
7. An acute illness, including COVID-19, requiring hospitalization within the past 3 months or any acute illness, including COVID-19, within the past month.
8. Has a history of anaphylaxis from vitamin B3 derivatives
9. BMI \> 42.5 kg/ m2
10. If patient has a confirmed diagnosis of type 3 diabetes, or gestational diabetes.
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.