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

NCT ID: NCT01232257

Last Updated: 2012-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-12-31

Brief Summary

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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

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Conditions

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Chronic Kidney Disease Chronic Kidney Failure End Stage Kidney Disease End Stage Renal Disease

Keywords

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Chronic kidney disease Chronic kidney failure End stage kidney disease End stage renal disease Hydrogen sulfide N-acetylcysteine Acetylcysteine

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Healthy volunteers

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

4 gifts of N-acetylcysteine 600 mg BID

CKD patients

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

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

4 gifts of N-acetylcysteine 600 mg BID

Hemodialysis patients

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

4 gifts of N-acetylcysteine 600 mg BID

Peritoneal dialysis patients

Group Type EXPERIMENTAL

N-acetylcysteine

Intervention Type DRUG

4 gifts of N-acetylcysteine 600 mg BID

Interventions

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N-acetylcysteine

4 gifts of N-acetylcysteine 600 mg BID

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A.C. Abrahams

OTHER

Sponsor Role lead

Responsible Party

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A.C. Abrahams

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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M C Verhaar, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

A C Abrahams, MD

Role: PRINCIPAL_INVESTIGATOR

UMC Utrecht

Locations

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UMC Utrecht

Utrecht, , Netherlands

Site Status

Countries

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Netherlands

Other Identifiers

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H2S-NAC

Identifier Type: -

Identifier Source: org_study_id