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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
A.C. Abrahams, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT01232257
First received: November 1, 2010
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Hydrogen sulfide (H2S) [ Time Frame: After 48 hours ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: A.C. Abrahams, MD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT01232257     History of Changes
Other Study ID Numbers: H2S-NAC
Study First Received: November 1, 2010
Last Updated: October 25, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by 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
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases
Acetylcysteine
N-monoacetylcystine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes

ClinicalTrials.gov processed this record on May 21, 2013