Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)

October 25, 2012 updated by: A.C. Abrahams

Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease

Cardiovascular morbidity and mortality is high in CKD patients. Nitric oxide (NO) deficiency plays a crucial role in progression of CKD. This leads to endothelial dysfunction, hypertension, and inflammation. Hydrogen sulfide (H2S) could serve as a backup mechanism for NO deficiency in CKD. N-acetylcysteine (NAC) is a derivate of cysteine and this is the main substrate for H2S production. Therefore, NAC should enable us to stimulate H2S production in humans. Our objective is to investigate the effect of NAC on plasma H2S levels and on markers of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD patients, and dialysis patients. We hypothesize that there is an increase in H2S levels after treatment with NAC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion criteria:

Healthy volunteers:

  • Adult (> 18 years and older)
  • Healthy, as assessed by medical history, blood pressure, plasma creatinine, and urine dipstick
  • No medication use

CKD patient:

  • Adult (> 18 years and older)
  • CKD stage 3-4 (GFR 15-60 ml/min)

Hemodialysis patient:

  • Adult (> 18 years and older)
  • Hemodialysis patient

Peritoneal dialysis patient:

  • Adult (> 18 years and older)
  • Peritoneal dialysis patient

Exclusion criteria:

  • Unable to give informed consent
  • Hypersensitivity to N-acetylcysteine
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Healthy volunteers
Drug: N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID
Experimental: CKD patients
Patients with CKD stage 3-4 (GFR 15-60 ml/min)
Drug: N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID
Experimental: Hemodialysis patients
Drug: N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID
Experimental: Peritoneal dialysis patients
Drug: N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hydrogen sulfide (H2S)
Time Frame: After 48 hours
Investigate the effect of N-acetylcysteine on plasma H2S levels and on markers of oxidative stress, inflammation, and endothelial dysfunction in healthy volunteers, CKD patients, and dialysis patients
After 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

A.C. Abrahams

Investigators

  • Principal Investigator: M C Verhaar, MD, PhD, UMC Utrecht
  • Principal Investigator: A C Abrahams, MD, UMC Utrecht

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 1, 2010

First Submitted That Met QC Criteria

November 1, 2010

First Posted (Estimate)

November 2, 2010

Study Record Updates

Last Update Posted (Estimate)

October 26, 2012

Last Update Submitted That Met QC Criteria

October 25, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H2S-NAC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on End Stage Renal Disease

Clinical Trials on N-acetylcysteine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Finland

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe