Optimalization of Nephroprotection Using N-Acetylcysteine

NCT00572663 | Completed

• 1 other identifier: ST-4/NAC/01
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Kidney Disease; Proteinuria

Keywords

Proteinuria; Antioxidant; N-acetylcysteine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

ACC (N-acetylcysteine) 1200 mg DRUG

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medical University of Gdansk: lead

Related Publications (1)

• Colombijn JM, Hooft L, Jun M, Webster AC, Bots ML, Verhaar MC, Vernooij RW. Antioxidants for adults with chronic kidney disease. Cochrane Database Syst Rev. 2023 Nov 2;11(11):CD008176. doi: 10.1002/14651858.CD008176.pub3.

  PMID: 37916745 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Proteinuria

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Urination Disorders; Urological Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Boleslaw Rutkowski, MD PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 13, 2007
• Study Start: January 1, 2005
• Last Updated: December 13, 2007

Record last verified: 2007-12