Optimalization of Nephroprotection Using N-Acetylcysteine
Information source: Medical University of Gdansk
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Kidney Disease; Proteinuria
Intervention: ACC (N-acetylcysteine) 1200 mg (Drug)
Phase: N/A
Status: Completed
Sponsored by: Medical University of Gdansk Official(s) and/or principal investigator(s): Boleslaw Rutkowski, MD PhD, Principal Investigator, Affiliation: Department of Nephrology Transplantology and Internal Medicine. Medical University of Gdansk
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: 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: 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
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2005
Last updated: December 12, 2007
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