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

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ClinicalTrials.gov Identifier: NCT01232257
Recruitment Status : Completed
First Posted : November 2, 2010
Last Update Posted : October 26, 2012
Sponsor:
Information provided by (Responsible Party):
A.C. Abrahams, UMC Utrecht

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Chronic Kidney Failure End Stage Kidney Disease End Stage Renal Disease Drug: N-acetylcysteine Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease
Study Start Date : July 2011
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232257


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
A.C. Abrahams
Investigators
Principal Investigator: M C Verhaar, MD, PhD UMC Utrecht
Principal Investigator: A C Abrahams, MD UMC Utrecht
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: A.C. Abrahams, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01232257     History of Changes
Other Study ID Numbers: H2S-NAC
First Posted: November 2, 2010    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by A.C. Abrahams, UMC Utrecht:
Chronic kidney disease
Chronic kidney failure
End stage kidney disease
End stage renal disease
 Hydrogen sulfide
N-acetylcysteine
Acetylcysteine

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Renal Insufficiency
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Hydrogen Sulfide
Antiviral Agents
Anti-Infective Agents
 Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Gasotransmitters
Neurotransmitter Agents