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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 month
Awards & highlights
DKD Trial Summary
This trial will test if taking a certain medicine can help people with a kidney disease, with participants taking either the medicine or placebo.
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.Check my eligibility
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.See study design
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.
DKD Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 month
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 month
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The primary endpoint is the change from baseline in UACR over the 6-month intervention period.
Secondary outcome measures
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 moreDKD 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.
Find a Location
Who is running the clinical trial?
Boston Medical CenterOTHER
384 Previous Clinical Trials
871,490 Total Patients Enrolled
Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,808 Total Patients Enrolled
Shalender Bhasin, MDPrincipal InvestigatorBrigham and Women's Hospital
15 Previous Clinical Trials
7,377 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.You have type 2 diabetes, high levels of certain blood glucose markers, and are currently taking specific diabetes medications.Your urine test shows a high level of protein first thing in the morning.Your liver enzymes (AST or ALT) are more than 3 times the normal level.Your hematocrit level is too low or too high.Your creatinine level is higher than 2.5 mg/dL.I do not have major mental health issues that could affect my participation.Your body mass index (BMI) is higher than 42.5.I have conditions that could make participating unsafe for me.
Research Study Groups:
This trial has the following groups:- Group 1: Investigational Product - MIB 626
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has the FDA authorized use of Investigational Product - MIB 626?
"Due to the lack of evidence regarding efficacy, Investigational Product - MIB 626 scored a 2 on our team's safety scale. This is because it is still in Phase 2 clinical trials which have provided some data indicating its security."
Answered by AI
Is enrollment for this experiment still active at the present time?
"Per the details posted on clinicaltrials.gov, this experiment is still in need of participants and actively recruiting them. This investigation was initially made available to the public on April 13th 2023 with its last update occurring 8 days later."
Answered by AI
How many study participants are currently enrolled in this research project?
"Affirmative, according to clinicialtrials.gov this experiment is currently seeking volunteers. It was first published on April 13th 2023 and the latest update occurred 8 days later, which indicates 140 individuals from 1 site are desired for enrollment."
Answered by AI
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