Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2025-12-28 @ 12:13 PM
Study NCT ID:
NCT01232257
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2010-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}, {'id': 'D007676', 'term': 'Kidney Failure, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000111', 'term': 'Acetylcysteine'}], 'ancestors': [{'id': 'D003545', 'term': 'Cysteine'}, {'id': 'D000603', 'term': 'Amino Acids, Sulfur'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000596', 'term': 'Amino Acids'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2010-11-01', 'studyFirstSubmitQcDate': '2010-11-01', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Hydrogen sulfide (H2S)', 'timeFrame': 'After 48 hours', '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'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic kidney disease', 'Chronic kidney failure', 'End stage kidney disease', 'End stage renal disease', 'Hydrogen sulfide', 'N-acetylcysteine', 'Acetylcysteine'], 'conditions': ['Chronic Kidney Disease', 'Chronic Kidney Failure', 'End Stage Kidney Disease', 'End Stage Renal Disease']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\nHealthy volunteers:\n\n* Adult (\\> 18 years and older)\n* Healthy, as assessed by medical history, blood pressure, plasma creatinine, and urine dipstick\n* No medication use\n\nCKD patient:\n\n* Adult (\\> 18 years and older)\n* CKD stage 3-4 (GFR 15-60 ml/min)\n\nHemodialysis patient:\n\n* Adult (\\> 18 years and older)\n* Hemodialysis patient\n\nPeritoneal dialysis patient:\n\n* Adult (\\> 18 years and older)\n* Peritoneal dialysis patient\n\nExclusion criteria:\n\n* Unable to give informed consent\n* Hypersensitivity to N-acetylcysteine\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT01232257', 'briefTitle': 'Effect of N-acetylcysteine (NAC) on Hydrogen Sulfide (H2S) in Chronic Kidney Disease (CKD)', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'Effect of N-acetylcysteine on Hydrogen Sulfide in Chronic Kidney Disease', 'orgStudyIdInfo': {'id': 'H2S-NAC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'CKD patients', 'description': 'Patients with CKD stage 3-4 (GFR 15-60 ml/min)', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'Hemodialysis patients', 'interventionNames': ['Drug: N-acetylcysteine']}, {'type': 'EXPERIMENTAL', 'label': 'Peritoneal dialysis patients', 'interventionNames': ['Drug: N-acetylcysteine']}], 'interventions': [{'name': 'N-acetylcysteine', 'type': 'DRUG', 'description': '4 gifts of N-acetylcysteine 600 mg BID', 'armGroupLabels': ['CKD patients', 'Healthy volunteers', 'Hemodialysis patients', 'Peritoneal dialysis patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3584 CX', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'UMC Utrecht', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}], 'overallOfficials': [{'name': 'M C Verhaar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}, {'name': 'A C Abrahams, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMC Utrecht'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'A.C. Abrahams', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'A.C. Abrahams', 'investigatorAffiliation': 'UMC Utrecht'}}}}