NAD Augmentation in Diabetes Kidney Disease (NCT05759468) | Clinical Trial Compass
RecruitingPhase 2
NAD Augmentation in Diabetes Kidney Disease
United States156 participantsStarted 2023-04-13
Plain-language 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. Eligible participants will be randomized to receive either 1000 mg NMN or placebo twice daily.
Who can participate
Age range30 Years
SexALL
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Inclusion criteria
✓. 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.
✓. 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
Exclusion criteria
✕. 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
✕
What they're measuring
1
The primary endpoint is the change from baseline in UACR over the 6-month intervention period.