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

NCT01232257 | Completed Phase 3

• 1 other identifier: H2S-NAC
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Hydrogen sulfide (H2S)

  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

  After 48 hours

Study Arms (4)

Healthy volunteers

EXPERIMENTAL

Drug: N-acetylcysteine

CKD patients

EXPERIMENTAL

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

Drug: N-acetylcysteine

Hemodialysis patients

EXPERIMENTAL

Drug: N-acetylcysteine

Peritoneal dialysis patients

EXPERIMENTAL

Drug: N-acetylcysteine

Interventions

N-acetylcysteine DRUG

4 gifts of N-acetylcysteine 600 mg BID

CKD patients; Healthy volunteers; Hemodialysis patients; Peritoneal dialysis patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Unable to give informed consent
• Hypersensitivity to N-acetylcysteine
• Pregnancy

Sponsors & Collaborators

• A.C. Abrahams: lead

Study Sites (1)

UMC Utrecht

Utrecht, 3584 CX, Netherlands

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Failure, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• M C Verhaar, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

• A C Abrahams, MD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 1, 2010
• First Posted: November 2, 2010
• Study Start: July 1, 2011
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

NL (1)