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

Phase 3

Completed

• Conditions: Chronic Kidney Disease; Chronic Kidney Failure; End Stage Kidney Disease; End Stage Renal Disease
• Interventions: Drug: N-acetylcysteine

• Registration Number: NCT01232257
• Lead Sponsor: A.C. Abrahams

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-11-01
• Study First Submitted QC: 2010-11-01
• Study First Posted: 2010-11-02
• Study Start: 2011-07
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-25
• Last Update Posted: 2012-10-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	N-acetylcysteine	-
CKD patients	N-acetylcysteine	Patients with CKD stage 3-4 (GFR 15-60 ml/min)
Hemodialysis patients	N-acetylcysteine	-
Peritoneal dialysis patients	N-acetylcysteine	-

Primary Outcome Measures

Name	Time	Method
Hydrogen sulfide (H2S)	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

Trial Locations

Locations (1)

UMC Utrecht; 🇳🇱 Utrecht, Netherlands