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

A.C. Abrahams

Status and phase: Completed; Phase 3

Conditions: Chronic Kidney Disease; Chronic Kidney Failure; End Stage Renal Disease; End Stage Kidney Disease

Treatments: Drug: N-acetylcysteine

Study type: Interventional

Funder types: Other

Identifiers

NCT01232257

H2S-NAC

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 4 patient groups

Healthy volunteers

Experimental group

Treatment:

Drug: N-acetylcysteine

CKD patients

Experimental group

Description:

Patients with CKD stage 3-4 (GFR 15-60 ml/min)

Treatment:

Drug: N-acetylcysteine

Hemodialysis patients

Experimental group

Treatment:

Drug: N-acetylcysteine

Peritoneal dialysis patients

Experimental group

Treatment:

Drug: N-acetylcysteine