Type2diabetesPhase 2DKDNCT05759468
NAD Augmentation in Diabetes Kidney Disease
A Phase 2 study testing Investigational Product - MIB 626 in people with Type2diabetes and Diabetic Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Type2diabetes, Diabetic Kidney Disease
- What is being tested?
- Investigational Product - MIB 626
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Apr 2023to 31 Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Nancy K Latham, PhD, 6179999195, nklatham@bwh.harvard.edu
Shalender Bhasin, MB BS
About this study
Official title: NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled 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.
Read the detailed description
This will be two centers, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.
The trial will enroll community-dwelling older adults, 60 years or older, with type 2 diabetes mellitus (T2DM) and urine albumin to creatinine excretion ratio > 100 mg/ g creatinine.
- Conditions
- Type2diabetes, Diabetic Kidney Disease
- Being tested
- Investigational Product - MIB 626, Placebo
- Keywords
- diabetes, type 2 diabetes, kidney disease
- Medical subject headings
- Diabetic Nephropathies, Diabetes Mellitus, Diabetes Mellitus, Type 2, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Product - MIB 626Drug
Also called NMN
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.
PlaceboDrug
Also called Placebo for NMN
Placebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product - MIB 626 | Active comparator | The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily. Receives: Drug: Investigational Product - MIB 626 |
| Placebo | Placebo comparator | Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (10)
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
Measured: 6 months
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.
Measured: 6 month
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.
Measured: 6 month
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.
Measured: 6 month
To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance.
Assess the change from baseline in muscle endurance by exercises (reps to failure) using Keiser Machines
Measured: 6 month
Assess the change from baseline in performance-based measures of function.
To determine whether NMN treatment is associated with significantly greater improvement in performance based by using 6-minute walking distance measure of function.
Measured: 6 month
To determine whether NMN alters the circulating biomarkers of aging that the geroscience experts have recommended.
Compared to placebo treatment, NMN treatment will be assessed to identify greater changes in the circulating biomarkers of aging. the biomarkers that will be assessed are IL6 and TNFalpha
Measured: 6 months
Assess the change from baseline in the levels of NMN in the peripheral blood and in the PBMCs using a validated LC-MS/MS assay.
NMN treatment will be assessed to determine significant increases in blood levels of NAD and its metabolome during the 24-week intervention period. The increase in NAD levels are to be observed during the intervention period in NMN-treated subjects that will be sustained during the 12-week follow-up period (legacy effect).
Measured: 6 months
Assess the change in measure of H1bac as a measure of glycemic control over the 6 months intervention period.
To determine the effect of NMN treatment on Hb1ac (expressed in mg/dL) in the body as a measure of glycemic control.
Measured: 6 months
Assess the change in measure of fasting glucose as a measure of glycemic control over the 6 months intervention period.
To determine the effect of NMN treatment on fasting glucose in the body as a measure of glycemic control.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2023
- Study start13 Apr 2023
- Primary completion30 Nov 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type2diabetesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be three center, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Medical Center
- Responsible party
- Principal investigator, Shalendar Bhasin, MD, Brigham and Women's Hospital
- Investigators
- Shalender Bhasin, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05759468
- Sponsor's protocol ID
- 2021P003702
- Acronym
- DKD
- Status last verified
- Feb 2026
- First submitted
- 9 Jan 2023
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared
Publications
Chandra MS, Gagliano-Juca T, Shekhar S, Pencina KM, Travison TG, Garg R, McDonnell ME, Reid KF, Latham NK, Lam H, Meritus D, Yan Y, Isaza I, Weiss MF, Beleva YM, Bracken EM, Ruiz E, Wang C, Forman J, Waikar SS, Bhasin S. Nicotinamide Adenine Dinucleotide Augmentation in Diabetic Kidney Disease: Randomized Trial Study Protocol. Kidney Int Rep. 2026 Jul 16;11(10):106700. doi: 10.1016/j.ekir.2026.106700. eCollection 2026 Oct.
PubMed 42603990
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NAD Augmentation to Treat Diabetes Kidney Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05759468
- Acronym / sponsor ID
- DKD / 2021P003702
- Conditions
- Type2diabetes, Diabetic Kidney Disease
- Keywords
- diabetes, type 2 diabetes, kidney disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boston Medical Center
- Study start
- 13 Apr 2023 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 8 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be two centers, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.
The trial will enroll community-dwelling older adults, 60 years or older, with type 2 diabetes mellitus (T2DM) and urine albumin to creatinine excretion ratio > 100 mg/ g creatinine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be three center, randomized, double-blind, placebo-controlled, parallel group trial to determine whether βNMN, after its daily oral administration, is associated with a greater reduction in the UACR compared to placebo.
| Arm | Type | Receives |
|---|---|---|
| Investigational Product - MIB 626 | Active comparator | Drug: Investigational Product - MIB 626The MIB-626 will be a GMP-grade microcrystalline solid NMN mixed with inert excipients (including microcrystalline cellulose) and compressed into tablets at a dose strength of 500 mg per tablet, enabling administration of the 1,000 mg twice daily using two tablets taken twice daily. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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:
- 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.
- 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
Key exclusion criteria (13 listed)
- Fasting morning UACR > 5,000 mg/ g creatinine
- Other laboratory abnormalities:
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Product - MIB 626Also: NMNThe 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 | Investigational Product - MIB 626 |
| PlaceboAlso: Placebo for NMNPlacebo - Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC. | Drug | Placebo |
Primary outcome
The primary endpoint is the change from baseline in UACR over the 6-month intervention period.
Time frame: 6 months
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.
10 secondary outcomes
Assess the proportion of participants in the two study arms with 30% or greater reduction in UACR
Time frame: 6 months
Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury.
Time frame: 6 month
Change from baseline in the levels of serum creatinine over 6-month intervention period
Time frame: 6 month
Change from baseline in the levels of cystine C over 6-month intervention period.
Time frame: 6 month
To determine whether NMN treatment is associated with significantly greater improvement in muscle endurance.
Time frame: 6 month
Assess the change from baseline in performance-based measures of function.
Time frame: 6 month
To determine whether NMN alters the circulating biomarkers of aging that the geroscience experts have recommended.
Time frame: 6 months
Assess the change from baseline in the levels of NMN in the peripheral blood and in the PBMCs using a validated LC-MS/MS assay.
Time frame: 6 months
Assess the change in measure of H1bac as a measure of glycemic control over the 6 months intervention period.
Time frame: 6 months
Assess the change in measure of fasting glucose as a measure of glycemic control over the 6 months intervention period.
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Derived from this study: PubMed 42603990Chandra MS, Gagliano-Juca T, Shekhar S, Pencina KM, Travison TG, Garg R, McDonnell ME, Reid KF, Latham NK, Lam H, Meritus D, Yan Y, Isaza I, Weiss MF, Beleva YM, Bracken EM, Ruiz E, Wang C, Forman J, Waikar SS, Bhasin S. Nicotinamide Adenine Dinucleotide Augmentation in Diabetic Kidney Disease: Randomized Trial Study Protocol. Kidney Int Rep. 2026 Jul 16;11(10):106700. doi: 10.1016/j.ekir.2026.106700. eCollection 2026 Oct.
- Individual participant dataSharing planned: No. Individual participant data will not be shared
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shalender Bhasin, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Investigational Product - MIB 626 in people with Type2diabetes and Diabetic Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shalender Bhasin, MD (6175259150, sbhasin@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is the change from baseline in UACR over the 6-month intervention period. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05759468, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.