Chronic kidney disease End stage renal disease MedDRA version: 12.1 Level: LLT Classification code 10064848 Term: Chronic kidney disease MedDRA version: 12.1 Level: LLT Classification code 10014646 Term: End stage renal disease (ESRD)
Conditions
Interventions
Trade Name: Acetylcysteine
Product Name: Acetylcysteine
Pharmaceutical Form: Oral powder
INN or Proposed INN: ACETYLCYSTEINE
CAS Number: 616-91-1
Concentration unit: mg milligram(s)
Concentration type
Sponsors
UMC Utrecht
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Unable to give informed consent - Hypersensitivity to NAC - Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the effect of NAC on plasma H2S levels.;Secondary Objective: Investigate differences in plasma H2S levels between healthy volunteers, CKD patients, and dialysis patients.;Primary end point(s): H2S levels in plasma | — |
Countries
Netherlands
Outcome results
None listed