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Optimalization of Nephroprotection Using N-Acetylcysteine

This study has been completed.
Sponsor:
Information provided by:
Medical University of Gdansk
ClinicalTrials.gov Identifier:
NCT00572663
First received: December 12, 2007
Last updated: NA
Last verified: December 2007
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
Proteinuria
 Drug: ACC (N-acetylcysteine) 1200 mg

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Gdansk:

Primary Outcome Measures:
  • 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:
  • 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

Study Start Date: January 2005
Intervention Details:
    Drug: ACC (N-acetylcysteine) 1200 mg
    N-acetylcysteine (ACC) 1200 mg In the 8-weeks run-in period angiotensin converting enzyme inhibitors and/or angiotensin II subtype 1 receptor antagonists were administered to achieve the target blood pressure below 130/80 mmHg. Next, they were randomly assigned to add (or not) 1200 mg N-acetylcysteine in two active treatment periods lasting 8 weeks each
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00572663

Sponsors and Collaborators
Medical University of Gdansk
Investigators
Principal Investigator: Boleslaw Rutkowski, MD PhD Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00572663     History of Changes
Other Study ID Numbers: ST-4/NAC/01
Study First Received: December 12, 2007
Last Updated: December 12, 2007
Health Authority: Poland: Ministry of Health

Keywords provided by Medical University of Gdansk:
Proteinuria
Antioxidant
N-acetylcysteine

Additional relevant MeSH terms:
Kidney Diseases
Proteinuria
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Urination Disorders
Urological Manifestations
Signs and Symptoms
Renal Insufficiency
Acetylcysteine
N-monoacetylcystine
Angiotensin-Converting Enzyme Inhibitors
Antiviral Agents
 Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antidotes
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013