Overview

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