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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01232257
First Posted: November 2, 2010
Last Update Posted: October 26, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
A.C. Abrahams, UMC Utrecht
  Purpose
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 Intervention Phase
Chronic Kidney Disease Chronic Kidney Failure End Stage Kidney Disease End Stage Renal Disease Drug: N-acetylcysteine Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by A.C. Abrahams, UMC Utrecht:

Primary Outcome Measures:
  • 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


Enrollment: 28
Study Start Date: July 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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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
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

Responsible Party: A.C. Abrahams, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01232257     History of Changes
Other Study ID Numbers: H2S-NAC
First Submitted: November 1, 2010
First Posted: November 2, 2010
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