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

November 1, 2010
October 25, 2012
July 2011
December 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01232257 on ClinicalTrials.gov Archive Site
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Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Chronic Kidney Failure
  • End Stage Kidney Disease
  • End Stage Renal Disease
Drug: N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID
  • Experimental: Healthy volunteers
    Intervention: Drug: N-acetylcysteine
  • Experimental: CKD patients
    Patients with CKD stage 3-4 (GFR 15-60 ml/min)
    Intervention: Drug: N-acetylcysteine
  • Experimental: Hemodialysis patients
    Intervention: Drug: N-acetylcysteine
  • Experimental: Peritoneal dialysis patients
    Intervention: Drug: N-acetylcysteine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT01232257
H2S-NAC
No
A.C. Abrahams, UMC Utrecht
A.C. Abrahams
Not Provided
Principal Investigator: M C Verhaar, MD, PhD UMC Utrecht
Principal Investigator: A C Abrahams, MD UMC Utrecht
UMC Utrecht
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP