Efficacy of N-Acetylcysteine in Treatment of Overt Diabetic Nephropathy

Chronic Kidney Disease Clinical Trial

Official title:

Study of N-Acetylcysteine for Treatment of Overt Diabetic Nephropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00556465
• Other study ID #: 3046
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 9, 2007
• Last updated: November 9, 2007
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: November 2007
• Source: Shiraz University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

Diabetic nephropathy has become the single most frequent cause of end-stage renal disease.

On a molecular level, at least five major pathways have been implicated in glucose-mediated vascular and renal damage and all of these could reflect a single hyperglycaemia-induced process of overproduction of reactive oxygen species.

Recent studies have shown that inflammation, and more specifically pro-inflammatory cytokines play a determinant role in the development of micro- vascular diabetic complications, most of the attention has been focused on the implications of TNF-α in the setting of diabetic nephropathy.

Glutathione is the most abundant low-molecular-weight thiol, and Glutathione/ glutathione disulfide is the major redox couple in animal cells.

N-acetylcysteine is effective precursors of cysteine for tissue Glutathione synthesis.

Not only does N-acetylcysteine exhibit antioxidant properties, but it may also counteract the glycation cascade through the inhibition of oxidation.

N-acetylcysteine can also reduce the apoptosis elicited by reactive oxygen species .

Indeed, N-acetylcysteine has been shown to inhibit reactive oxygen species induced mesangial apoptosis and to be able to protect cells from glucose-induced inhibition of proliferation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• Diabetic patients with more than 500 mg protein in 24 hours urine protein sample

• Males and post-menopausal non-lactating and non-pregnant females.

• Age greater than or equal to 30 years of age.

• Serum creatinine less than 3.0 mg/dL (265 micromoles per liter)

• Willing and able to give informed consent

Exclusion Criteria:

• Type 1 (insulin-dependent; juvenile onset) diabetes

• Patients with known non-diabetic renal disease

• Renal allograft

• Myocardial infarction, coronary artery bypass graft surgery, or percutaneous transluminal coronary angioplasty/stent within 3 months of study entry

• Cerebrovascular accident within 3 months of study entry

• New York Heart Association Functional Class III or IV

• Known allergies or intolerance to N-acetylcysteine

• Untreated urinary tract infection or other medical condition that may impact urine protein values.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Diabetes Mellitus, Type 2
• Diabetes Type 2
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetylcysteine
600 mg of effervescent N-acetylcysteine tablet twice per day for three months

Locations

Country	Name	City	State
Iran, Islamic Republic of	Mohammad mahdi sagheb	Shiraz	Fars

Sponsors (1)

Lead Sponsor	Collaborator
Shiraz University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proteinuria		3 months
Secondary	blood pressure,serum creatinine,GFR,c-reactive protein,		3 months