Optimalization of Nephroprotection Using N-Acetylcysteine

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of the study is find whether the addition of N-acetylcysteine (antioxidant) to dual renin-angiotensin-aldosterone system blockade involving angiotensin converting enzyme inhibitor and AT-1 angiotensin II receptor blocker leads to the reduction of proteinuria, main prognostic marker of chronic kidney disease progression.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical University of Gdansk
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Chronic kidney disease

• Stable proteinuria above 300 mg/24 hours (no variations above 25% in the last 6 months)

• Normal or slightly impaired stable renal function defined as serum creatinine level below 1.7 mg/dl (eGFR > 45 ml/min)

Exclusion Criteria:

• Nephrotic syndrome

• Steroids or other immunosuppressive treatment minimum during six months before the study

• Diabetes mellitus

• Potassium serum level > 5.1 mEq/L

• Albumin serum level < 2.0mg/dL

• Creatinine serum level >2 mg/dl

• Current diagnosis of heart failure New York Heart Association (NYHA) Class II-IV

• Clinically significant valvular heart disease or second or third degree heart block without a pacemaker

• History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic cerebral attack

• History of myocardial infarction, unstable angina pectoris, coronary bypass surgery, or any percutaneous coronary intervention

• History of malignancy including leukemia and lymphoma (but not basal cell skin carcinoma) within the past five years

• Pregnant or nursing women

• Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of study drugs.

• History of alcohol abuse

• NSAID abuse (more than 2 doses per week)

• Known or suspected contraindications to the study medications, including history of allergy to ACE inhibitors, AT-1 receptor blockers and N-acetylcysteine