Optimalization of Nephroprotection Using N-Acetylcysteine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Brief Summary

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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

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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.

Conditions

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Chronic Kidney Disease Proteinuria

Keywords

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Proteinuria Antioxidant N-acetylcysteine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Boleslaw Rutkowski, MD PhD

Role: PRINCIPAL_INVESTIGATOR

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

References

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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.

Reference Type DERIVED

PMID: 37916745 (View on PubMed)

Other Identifiers

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ST-4/NAC/01

Identifier Type: -

Identifier Source: org_study_id