Radiocontrast-induced nephropathy
Conditions
Interventions
Trade Name: Parvolex
Pharmaceutical Form: Solution for injection
INN or Proposed INN: acetylcysteine
CAS Number: 616-91-1
Concentration unit: mg/ml milligram(s)/millilitre
Concentration type: equal
Co
Sponsors
University of Edinburgh
NHS Lothian Health Board
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Studies 1 & 3: Healthy male volunteers aged over 45 years, with a BMI between 22 and 40. Study 2: Male volunteers aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin. Study 4: Male patients aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin, undergoing elective coronary angiography. Study 5: Male patients aged over 45 years, with stable CKD stage III and a BMI between 22 and 40, not on metformin, undergoing elective CT. 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: Volunteers for Studies 1, 3 · lack of informed consent · age <46 years · current involvement in a clinical trial · clinically significant co-morbidity: heart failure, hypertension, known hyperlipidaemia, diabetes mellitus, coagulopathy or bleeding disorder. · thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium · current intake of prescription medicines · recent infective/inflammatory condition · blood donation during the preceding three months Patients for Studies 2, 4 and 5 · lack of informed consent · age <46 years · current involvement in a clinical trial · thyroid disease, myasthenia gravis, asthma, atopy, or a history of allergy/sensitivity to acetylcysteine or contrast medium · current intake of metformin · recent infective/inflammatory condition · blood donation during the preceding three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine how oral and intravenous acetylcysteine affects renal function in healthy volunteers and people with chronic kidney disease (CKD), in the presence and absence of radiocontrast.;Secondary Objective: To identify a rational dose of acetylcysteine, given through the correct route, and assessed using the correct outcome measure, that can be studied in a large phase III trial of acetylcysteine in radiocontrast-induced nephropathy.;Primary end point(s): Changes in RBF will be the primary outcome since we expect this measure to be the most sensitive to the effects of acetylcysteine and/or contrast administration. | — |
Countries
United Kingdom
Outcome results
None listed