Optimalization of Nephroprotection Using N-Acetylcysteine - Tabular View

Tracking Information

First Received Date ^ICMJE

December 12, 2007

Last Updated Date

December 12, 2007

Start Date ^ICMJE

January 2005

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Investigate the antiproteinuric effect of adding antioxidant, N-acetylcysteine to the combination therapy with angiotensin converting enzyme inhibitor and AT-1 receptor blocker in maximal recommended doses.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Investigate the effect of the study intervention on urine excretion of N-acetyl-β-D-glucosaminidase, alfa1-microglobulin and amino-terminal propeptide of type III procollagen

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Optimalization of Nephroprotection Using N-Acetylcysteine

Official Title ^ICMJE

The Effect of N-Acetylcysteine on Proteinuria and Markers of Tubular Injury in Non-Diabetic Patientswith Chronic Kidney Disease-Placebo Controlled, Randomized,Open, Cross-Over Study

Brief 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.

Detailed Description

The renin-angiotensin-aldosterone system (RAAS) plays an important role in the progression of chronic kidney diseases (CKD), and inhibition of the RAAS with angiotensin-converting enzyme inhibitors (ACEI) and angiotensin II type 1 receptor blockers (ARB) may retard CKD progression. Dual pharmacological blockade of the RAAS with ACEI and ARB is recommended as a standard renoprotective management at least in patients with nondiabetic proteinuric CKD. However, neither ACEI nor ARB, even in high doses or in concomitant usage, abrogate the progression of CKD completely. Innovative approaches are needed to keep patients with CKD off dialysis. Additional antioxidant (N-acetylcysteine) may prove to be such beneficial therapeutic concept. To shed more light on this issue, we performed a randomised open controlled study to evaluate the influence of triple N-acetylcysteine and RAAS therapy on surrogate markers of kidney injury, i.e. proteinuria, markers of tubular involvement and kidney fibrosis.

Study Phase

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study

Condition ^ICMJE

Chronic Kidney Disease
Proteinuria

Intervention ^ICMJE

Drug: ACC (N-acetylcysteine) 1200 mg

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00572663

Responsible Party

Study ID Numbers ^ICMJE

ST-4/NAC/01

Study Sponsor ^ICMJE

Medical University of Gdansk

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Boleslaw Rutkowski, MD PhD

Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk

Information Provided By

Medical University of Gdansk

Verification Date

December 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP