Chronic Kidney DiseasePhase 3NCT01232257
Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)
A Phase 3 study testing N-acetylcysteine in people with Chronic Kidney Disease and Chronic Kidney Failure, run by A.C. Abrahams at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Disease, Chronic Kidney Failure, End Stage Kidney Disease
- What is being tested?
- N-acetylcysteine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteNetherlands
- Study dates
- Jul 2011to Dec 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- Unable to give informed consent
- Hypersensitivity to N-acetylcysteine
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease
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
- Being tested
- N-acetylcysteine
- Keywords
- Chronic kidney disease, Chronic kidney failure, End stage kidney disease, End stage renal disease, Hydrogen sulfide, N-acetylcysteine, Acetylcysteine
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetylcysteineDrug
4 gifts of N-acetylcysteine 600 mg BID
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Experimental | Not described Receives: Drug: N-acetylcysteine |
| CKD patients | Experimental | Patients with CKD stage 3-4 (GFR 15-60 ml/min) Receives: Drug: N-acetylcysteine |
| Hemodialysis patients | Experimental | Not described Receives: Drug: N-acetylcysteine |
| Peritoneal dialysis patients | Experimental | Not described Receives: Drug: N-acetylcysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: After 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2010 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- A.C. Abrahams
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, A.C. Abrahams, UMC Utrecht
- Investigators
- M C Verhaar, MD, PhD, Principal investigator, UMC UtrechtA C Abrahams, MD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01232257
- Sponsor's protocol ID
- H2S-NAC
- Status last verified
- Oct 2012
- First submitted
- 1 Nov 2010
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01232257
- Acronym / sponsor ID
- H2S-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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- A.C. AbrahamsUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 2 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | Experimental | Drug: N-acetylcysteine |
| CKD patients | Experimental | Drug: N-acetylcysteinePatients with CKD stage 3-4 (GFR 15-60 ml/min) |
| Hemodialysis patients | Experimental | Drug: N-acetylcysteine |
| Peritoneal dialysis patients | Experimental | Drug: N-acetylcysteine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Adult (> 18 years and older)
- Healthy, as assessed by medical history, blood pressure, plasma creatinine, and urine dipstick
- No medication use
- Adult (> 18 years and older)
- CKD stage 3-4 (GFR 15-60 ml/min)
Key exclusion criteria (3 listed)
- Unable to give informed consent
- Hypersensitivity to N-acetylcysteine
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetylcysteine4 gifts of N-acetylcysteine 600 mg BID | Drug | CKD patients, Healthy volunteers, Hemodialysis patients, Peritoneal dialysis patients |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
M C Verhaar, MD, PhD principal investigator
UMC Utrecht
A C Abrahams, MD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N-acetylcysteine in people with Chronic Kidney Disease and Chronic Kidney Failure, run by A.C. Abrahams at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hydrogen sulfide (H2S) (time frame: After 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2012.