Related Experiment Video

Updated: Dec 12, 2025

Preparation of Naringenin Solution for In Vivo Application
08:18

Preparation of Naringenin Solution for In Vivo Application

Published on: August 10, 2021

3.7K

Biological Efficacy and Safety of Niacinamide in Patients With ADPKD

Mireille El Ters1,2, Xia Zhou1,2, Rebecca J Lepping3

  • 1Division of Nephrology and Hypertension, University of Kansas Medical Center, Kansas City, Kansas, USA.

Kidney International Reports
|August 11, 2020
PubMed
Abstract

Insights

Niacinamide, a sirtuin inhibitor, was tested in autosomal dominant polycystic kidney disease (ADPKD) patients. The study found niacinamide safe but ineffective in slowing kidney disease progression or inhibiting sirtuin activity.

Area of Science:

  • Nephrology
  • Genetics
  • Pharmacology

Background:

  • Autosomal dominant polycystic kidney disease (ADPKD) involves progressive kidney cyst enlargement and failure.
  • Sirtuin-1 is implicated in ADPKD progression by deacetylating p53.
  • Niacinamide, a sirtuin inhibitor, is explored as a potential therapeutic agent.

Purpose of the Study:

  • To assess the biological activity and safety of niacinamide in ADPKD patients.
  • To determine if niacinamide inhibits sirtuin activity by measuring p53 acetylation.
  • To evaluate the effect of niacinamide on kidney volume changes in ADPKD.

Main Methods:

  • Two studies were conducted: an open-label trial (N=10) and a randomized, double-blind, placebo-controlled trial (N=36).
  • ADPKD patients received oral niacinamide (30 mg/kg) or placebo for 12 months.
  • The primary endpoint was the ratio of acetylated p53 to total p53 in peripheral blood mononuclear cells (PBMCs).

Main Results:

  • Niacinamide did not show a sustained effect on p53 acetylation or kidney volume in ADPKD patients.
  • No significant differences were observed between niacinamide and placebo groups for the primary endpoint or kidney volume changes.
  • Niacinamide was well-tolerated, with no difference in adverse event incidence compared to placebo.

Conclusions:

  • Niacinamide is safe and well-tolerated in ADPKD patients.
  • The study did not detect sustained sirtuin inhibition over 12 months of niacinamide treatment.
  • Niacinamide showed no beneficial effect on ADPKD progression markers in this trial.
Keywords:
clinical trialniacinamidep53polycystic kidney diseasesirtuin

More Related Videos

Transfer of Manipulated Tumor-associated Neutrophils into Tumor-Bearing Mice to Study their Angiogenic Potential In Vivo08:19

Transfer of Manipulated Tumor-associated Neutrophils into Tumor-Bearing Mice to Study their Angiogenic Potential In Vivo

Published on: July 20, 2019

6.3K
A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition04:53

A Clinical Trial Assessing the Safety, Efficacy, and Delivery of Olive-Oil-Based Three-Chamber Bags for Parenteral Nutrition

Published on: September 20, 2019

11.0K

Related Concept Videos

Pharmacokinetics in Pediatric Patients: Drug Excretion01:26

Pharmacokinetics in Pediatric Patients: Drug Excretion

In pediatric medicine, understanding the renal function and drug elimination nuances is crucial for administering safe and effective treatments. Newborns, in particular, display markedly slower renal functions than adults, profoundly affecting how drugs are cleared from their bodies. This slower drug clearance requires clinicians to extend the dosing intervals for many medications to prevent drug accumulation and toxicity while ensuring therapeutic efficacy.One key area where these adjustments...
131
Bioavailability Study Design: Healthy Subjects Versus Patients01:15

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...
71
Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment01:08

Effect of Hepatic Disease on Pharmacokinetics: Dose Adjustments Due to Hepatic Impairment

Hepatic impairment, characterized by decreased liver function, does not uniformly mandate adjustments in drug dosage. Whether dosage modifications are necessary depends on various factors related to the drug's metabolism and elimination pathways. If a drug is primarily excreted via the kidneys and bypasses significant hepatic processing, if it undergoes minimal metabolic transformation in the liver, or if it is volatile and primarily expelled through the lungs, dose adjustments may not be...
106
Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption01:23

Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption

Understanding the physiological differences in the pediatric population is crucial for effective pharmacotherapy. Neonates, infants, and children exhibit significant variations in gastric pH, gastric emptying time, intestinal transit time, and biliary function. These variations profoundly affect oral drug absorption, necessitating a nuanced approach to pediatric dosing.Neonates present with a unique physiological profile, having a gastric pH greater than 4 and faster and more irregular gastric...
147
Pharmacokinetics in Pediatric Patients: Drug Metabolism01:24

Pharmacokinetics in Pediatric Patients: Drug Metabolism

In pediatric care, understanding the nuances of hepatic drug metabolism is crucial, as it significantly differs from that of adults. This divergence is primarily due to the developmental stage of drug-metabolizing enzymes, which affects how medications are processed in the body. In neonates, for instance, the activity of Phase I enzymes—critical for the initial breakdown of drugs—is markedly reduced, functioning at just 20–40% of the levels seen in adults. This reduction poses...
111
Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test01:22

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...
106