140 Participants Needed

NAD Augmentation for Diabetic Kidney Disease

(DKD Trial)

SB
NR
NL
Overseen ByNancy Latham, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Brigham and Women's Hospital
Must be taking: ACE inhibitors, ARBs
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if your UACR is over 300 mg/g creatinine, you must be using an ACE inhibitor or an ARB. It's best to discuss your current medications with the trial team.

What data supports the effectiveness of the drug MIB-626 for diabetic kidney disease?

Research shows that nicotinamide, a component of MIB-626, can reduce kidney inflammation and slow down kidney disease progression in animal models. Additionally, nicotinamide supplementation has been linked to improved kidney outcomes in other kidney-related conditions.12345

Is NAD augmentation with βNMN safe for humans?

Research shows that βNMN, a form of NAD augmentation, is generally safe for humans. In studies, healthy adults taking up to 1250 mg daily for 4 weeks experienced no severe side effects, and similar safety was observed in animal studies with higher doses.16789

How is the drug MIB-626 unique for treating diabetic kidney disease?

MIB-626 is unique because it is an oral formulation of a specific form of nicotinamide mononucleotide (βNMN) that increases levels of nicotinamide adenine dinucleotide (NAD+), which is important for energy production and reducing inflammation. This approach is different from other treatments as it targets the underlying metabolic pathways to potentially improve kidney function.123410

What is the purpose of this trial?

This trial is testing whether NMN, a compound that may improve cell function, can help older adults with type 2 diabetes and high urine protein levels. The goal is to see if NMN can reduce kidney damage by improving cell energy production. Participants will receive NMN to compare the effects.

Research Team

SB

Shalender Bhasin, MD

Principal Investigator

Brigham and Women's Hospital

Eligibility Criteria

This trial is for adults with Type 2 Diabetes and Diabetic Kidney Disease. Participants must have a certain level of kidney function, controlled blood sugar levels, and be on specific medications if their urine shows high protein levels. Pregnant women or those planning pregnancy soon cannot join. People with recent serious health events, severe psychiatric conditions, very high BMI, substance abuse history, or who've been in other drug trials recently are excluded.

Exclusion Criteria

I have not had a major heart problem in the last 3 months.
You have had a problem with alcohol or drugs in the last 2 years.
Your urine test shows a high level of protein first thing in the morning.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either 1000 mg NMN or placebo twice daily to assess improvements in DKD over a 6-month period

24 weeks
Regular visits for monitoring and assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment, with a focus on sustained NAD levels

12 weeks

Treatment Details

Interventions

  • Investigational Product - MIB 626
  • Placebo
Trial Overview The study tests MIB 626 (a form of NMN) to see if it can improve kidney function in diabetic patients better than a placebo. It's randomized and double-blind meaning neither the researchers nor participants know who gets the real treatment versus a fake one (placebo). Each participant takes either MIB 626 or placebo twice daily.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Investigational Product - MIB 626Active Control1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Participants randomized to placebo will receive Matching placebo tablets will be provided by Metro International Biotech, LLC.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials
1,694
Recruited
14,790,000+

Boston Medical Center

Collaborator

Trials
410
Recruited
890,000+

Findings from Research

In a double-blind, placebo-controlled study involving 32 overweight or obese adults aged 55-80, the microcrystalline formulation MIB-626 was found to be safe and well-tolerated, with no significant differences in adverse events compared to placebo.
MIB-626 significantly increased blood levels of nicotinamide mononucleotide (NMN) and nicotinamide adenine dinucleotide (NAD) in a dose-dependent manner, suggesting its potential to enhance NAD metabolism and support healthspan.
MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-Aged and Older Adults.Pencina, KM., Lavu, S., Dos Santos, M., et al.[2023]
In a study of 167 cardiac bypass surgery patients, a significant decrease in urinary tryptophan and kynurenin was observed in those who developed acute kidney injury (AKI), indicating a potential biomarker for AKI risk.
However, supplementation with nicotinamide (NAM) did not improve kidney function or outcomes in a mouse model of ischaemic AKI, suggesting that NAM may not be an effective treatment for preventing renal damage in this context.
The tryptophan pathway and nicotinamide supplementation in ischaemic acute kidney injury.Piedrafita, A., Balayssac, S., Mayeur, N., et al.[2022]
Modified-release nicotinamide (NAMR) significantly reduced serum phosphate levels in hemodialysis patients over the first 24 weeks, but this effect was not maintained at 52 weeks, indicating potential issues with long-term efficacy.
The treatment was associated with increased risks of side effects such as thrombocytopenia, pruritus, anemia, and diarrhea, as well as herpes zoster occurring only in NAMR patients, highlighting the need for careful monitoring of safety.
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial.Ketteler, M., Wiecek, A., Rosenkranz, AR., et al.[2023]

References

MIB-626, an Oral Formulation of a Microcrystalline Unique Polymorph of β-Nicotinamide Mononucleotide, Increases Circulating Nicotinamide Adenine Dinucleotide and its Metabolome in Middle-Aged and Older Adults. [2023]
The tryptophan pathway and nicotinamide supplementation in ischaemic acute kidney injury. [2022]
Modified-release nicotinamide for the treatment of hyperphosphataemia in haemodialysis patients: 52-week efficacy and safety results of the phase 3 randomized controlled NOPHOS trial. [2023]
Nicotinamide Attenuates the Progression of Renal Failure in a Mouse Model of Adenine-Induced Chronic Kidney Disease. [2021]
Effect of nicotinamide on newly diagnosed type 1 diabetic children. [2013]
Safety evaluation of β-nicotinamide mononucleotide oral administration in healthy adult men and women. [2022]
Safety evaluation after acute and sub-chronic oral administration of high purity nicotinamide mononucleotide (NMN-C®) in Sprague-Dawley rats. [2021]
Effect of nicotinamide mononucleotide on insulin secretion and gene expressions of PDX-1 and FoxO1 in RIN-m5f cells. [2022]
Effects of nicotinamide mononucleotide on older patients with diabetes and impaired physical performance: A prospective, placebo-controlled, double-blind study. [2023]
N(1)-methylnicotinamide as an endogenous probe for drug interactions by renal cation transporters: studies on the metformin-trimethoprim interaction. [2018]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security