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 Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease

Resource links provided by NLM:

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Acetylcysteine

U.S. FDA Resources

Further study details as provided by A.C. Abrahams, UMC Utrecht:

Primary Outcome Measures:

Hydrogen sulfide (H2S) [ Time Frame: 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


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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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

Keywords provided by A.C. Abrahams, 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 Renal Insufficiency, Chronic Kidney Failure, Chronic Renal Insufficiency Urologic Diseases Acetylcysteine N-monoacetylcystine Hydrogen Sulfide Antiviral Agents Anti-Infective Agents	Expectorants Respiratory System Agents Free Radical Scavengers Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Physiological Effects of Drugs Antidotes Gasotransmitters Neurotransmitter Agents

ClinicalTrials.gov processed this record on August 18, 2017

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