What is the mechanism of action of this treatment?

Common treatments for Diabetic Kidney Disease (DKD) focus on reducing oxidative stress, inflammation, and fibrosis, which are key contributors to disease progression. Nicotinamide Mononucleotide (NMN), a precursor to NAD+, enhances cellular energy metabolism and has shown potential in improving kidney function by addressing these mechanisms. Other treatments include insulin or GLP-1 receptor agonists to control blood glucose levels, and ACE inhibitors or ARBs to manage blood pressure and reduce glomerular pressure and proteinuria. These treatments are crucial for DKD patients as they target the underlying causes of kidney damage, potentially slowing disease progression and improving kidney health.

What side effects are associated with this type of intervention?

Common treatments for Diabetic Kidney Disease (DKD) include metformin, coenzyme Q10, and sitagliptin. Metformin can cause gastrointestinal distress, lactic acidosis (especially in patients with impaired renal function), and is contraindicated in patients with severe kidney impairment. Coenzyme Q10 is generally well-tolerated but may cause mild gastrointestinal symptoms. Sitagliptin, a DPP-4 inhibitor, can lead to increased risk of infections, gastrointestinal issues, and potential interactions with other medications affecting kidney function. NMN, currently under study, has shown promise in improving kidney function by enhancing cellular energy metabolism, but its side effects are not yet fully established.

What prior FDA approvals exist?

The FDA has approved several treatments for Diabetic Kidney Disease (DKD), focusing primarily on controlling blood glucose levels and managing hypertension to slow disease progression. While specific approvals for NMN (Nicotinamide Mononucleotide) are not mentioned, treatments that target metabolic pathways include SGLT2 inhibitors like canagliflozin and dapagliflozin, which have shown benefits in reducing the progression of DKD. Additionally, GLP-1 receptor agonists such as liraglutide have been approved for their glucose-lowering effects and potential renal benefits. These treatments, while not identical to NMN, share a focus on improving metabolic function and kidney health.

What other types of research exist?

<ol> <li>Aminoguanidine: This compound has shown to significantly prolong survival in azotemic-induced diabetic rats, suggesting potential benefits in human diabetes and possibly DKD. 2.</li> </ol> Rosiglitazone: This drug has been shown to improve glomerular hyperfiltration, renal endothelial dysfunction, and microalbuminuria in patients with incipient diabetic nephropathy. 3. Mono Component (MC) Insulin: Compared to conventional insulin, MC insulin has shown a lower percentage of patients with deterioration in proteinuria and a higher percentage of improvement, indicating better management of nephropathy in diabetic patients.

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NAD+ precursor

NAD Augmentation for Diabetic Kidney Disease (DKD Trial)

Phase 2

Recruiting

Led By Shalender Bhasin, MD

Research Sponsored by Brigham and Women's Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Major depressive disorder, bipolar disorder, schizophrenia, or current psychotic symptoms or behavioral problems that could interfere with study procedures

Hypoglycemia unawareness or other medical conditions which could jeopardize participant's safety

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 month

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects aren't listed here, investigational products like MIB 626 could potentially cause unexpected reactions since they're under evaluation. Common drug-related side effects might include digestive issues, headaches, dizziness or allergic reactions.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have major mental health issues that could affect my participation.

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I have conditions that could make participating unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 month for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The primary endpoint is the change from baseline in UACR over the 6-month intervention period.

Secondary study objectives

Assess the change from baseline in performance-based measures of function.

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.

Assess the change from baseline over the 6-month intervention period in biomarkers of kidney injury.

+7 more

Trial Design

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.

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Kidney Disease (DKD) focus on reducing oxidative stress, inflammation, and fibrosis, which are key contributors to disease progression. Nicotinamide Mononucleotide (NMN), a precursor to NAD+, enhances cellular energy metabolism and has shown potential in improving kidney function by addressing these mechanisms. Other treatments include insulin or GLP-1 receptor agonists to control blood glucose levels, and ACE inhibitors or ARBs to manage blood pressure and reduce glomerular pressure and proteinuria. These treatments are crucial for DKD patients as they target the underlying causes of kidney damage, potentially slowing disease progression and improving kidney health.

Enhancement of cGMP-dependent pathway activity ameliorates hyperglycemia-induced decrease in SIRT1-AMPK activity in podocytes: Impact on glucose uptake and podocyte function.Differential role of nicotinamide adenine dinucleotide deficiency in acute and chronic kidney disease.Diabetic nephropathy: A potential savior with 'rotten-egg' smell.

Find a Location

Who is running the clinical trial?

Boston Medical CenterOTHER

401 Previous Clinical Trials

883,689 Total Patients Enrolled

Brigham and Women's HospitalLead Sponsor

1,664 Previous Clinical Trials

11,834,846 Total Patients Enrolled

Shalender Bhasin, MDPrincipal InvestigatorBrigham and Women's Hospital

15 Previous Clinical Trials

7,377 Total Patients Enrolled

Media Library

Investigational Product - MIB 626 (NAD+ precursor) Clinical Trial Eligibility Overview. Trial Name: NCT05759468 — Phase 2

Diabetic Kidney Disease Research Study Groups: Investigational Product - MIB 626, Placebo

Diabetic Kidney Disease Clinical Trial 2023: Investigational Product - MIB 626 Highlights & Side Effects. Trial Name: NCT05759468 — Phase 2

Investigational Product - MIB 626 (NAD+ precursor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05759468 — Phase 2

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