Optimalization of Nephroprotection Using N-Acetylcysteine

December 12, 2007 updated by: Medical University of Gdansk

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Secondary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Gdansk

Investigators

  • Principal Investigator: Boleslaw Rutkowski, MD PhD, Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Study Registration Dates

First Submitted

December 12, 2007

First Submitted That Met QC Criteria

December 12, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Estimate)

December 13, 2007

Last Update Submitted That Met QC Criteria

December 12, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST-4/NAC/01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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