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Optimalization of Nephroprotection Using N-Acetylcysteine

Primary Purpose

Chronic Kidney Disease, Proteinuria

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ACC (N-acetylcysteine) 1200 mg
Sponsored by
Medical University of Gdansk
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Proteinuria, Antioxidant, N-acetylcysteine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    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

    Full Information

    First Posted
    December 12, 2007
    Last Updated
    December 12, 2007
    Sponsor
    Medical University of Gdansk
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00572663
    Brief Title
    Optimalization of Nephroprotection Using N-Acetylcysteine
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2007
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2005 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Medical University of Gdansk

    4. Oversight

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Kidney Disease, Proteinuria
    Keywords
    Proteinuria, Antioxidant, N-acetylcysteine

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    ACC (N-acetylcysteine) 1200 mg
    Intervention Description
    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
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Boleslaw Rutkowski, MD PhD
    Organizational Affiliation
    Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Optimalization of Nephroprotection Using N-Acetylcysteine

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