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

Primary Purpose

Chronic Kidney Disease, Chronic Kidney Failure, End Stage Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
N-acetylcysteine
Sponsored by
A.C. Abrahams
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Chronic kidney disease, Chronic kidney failure, End stage kidney disease, End stage renal disease, Hydrogen sulfide, N-acetylcysteine, Acetylcysteine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Healthy volunteers

CKD patients

Hemodialysis patients

Peritoneal dialysis patients

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 1, 2010
Last Updated
October 25, 2012
Sponsor
A.C. Abrahams
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1. Study Identification

Unique Protocol Identification Number
NCT01232257
Brief Title
Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)
Official Title
Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
A.C. Abrahams

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy volunteers
Arm Type
Experimental
Arm Title
CKD patients
Arm Type
Experimental
Arm Description
Patients with CKD stage 3-4 (GFR 15-60 ml/min)
Arm Title
Hemodialysis patients
Arm Type
Experimental
Arm Title
Peritoneal dialysis patients
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
N-acetylcysteine
Intervention Description
4 gifts of N-acetylcysteine 600 mg BID
Primary Outcome Measure Information:
Title
Hydrogen sulfide (H2S)
Description
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
Time Frame
After 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
M C Verhaar, MD, PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
A C Abrahams, MD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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