NCT00572663

Optimalization of Nephroprotection Using N-Acetylcysteine

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: —
• Sponsor: Medical University of Gdansk · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Kidney Disease
• Proteinuria

Interventions

Type	Name	Description
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

Timeline

• Start date: 2005-01-01
• First posted: 2007-12-13
• Last updated: 2007-12-13