Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)
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ClinicalTrials.gov Identifier: NCT01232257 |
Recruitment Status :
Completed
First Posted : November 2, 2010
Last Update Posted : October 26, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Kidney Disease Chronic Kidney Failure End Stage Kidney Disease End Stage Renal Disease | Drug: N-acetylcysteine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
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 |
Study Start Date : | July 2011 |
Actual Primary Completion Date : | December 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
---|---|
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 |
- 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01232257
Netherlands | |
UMC Utrecht | |
Utrecht, Netherlands, 3584 CX |
Principal Investigator: | M C Verhaar, MD, PhD | UMC Utrecht | |
Principal Investigator: | A C Abrahams, MD | UMC Utrecht |
Responsible Party: | A.C. Abrahams, MD, UMC Utrecht |
ClinicalTrials.gov Identifier: | NCT01232257 |
Other Study ID Numbers: |
H2S-NAC |
First Posted: | November 2, 2010 Key Record Dates |
Last Update Posted: | October 26, 2012 |
Last Verified: | October 2012 |
Chronic kidney disease Chronic kidney failure End stage kidney disease End stage renal disease |
Hydrogen sulfide N-acetylcysteine Acetylcysteine |
Kidney Diseases Renal Insufficiency, Chronic Kidney Failure, Chronic Renal Insufficiency Urologic Diseases Acetylcysteine N-monoacetylcystine 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 |