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

Chronic Kidney Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01232257
• Other study ID #: H2S-NAC
• Status: Completed
• Phase: Phase 3
• First received: November 1, 2010
• Last updated: October 25, 2012
• Start date: July 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2012
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Kidney Failure
• End Stage Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetylcysteine
4 gifts of N-acetylcysteine 600 mg BID

Locations

Country	Name	City	State
Netherlands	UMC Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
A.C. Abrahams

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hydrogen sulfide (H2S)	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	No