NCT04916080

N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: Beni-Suef University · Academic / Other
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

Anemia is a common comorbidity of CKD and is associated with a decreased quality of life and increased healthcare resource utilization. Anemia increases the risk of CKD progression, cardiovascular complications, and overall mortality. The current standard of care includes oral or intravenous iron supplementation, erythropoiesis-stimulating agents, and red blood cell transfusion. Treatment with high doses of erythropoiesis-stimulating agents increases rates of hospitalization, cardiovascular events, and mortality. Resistance to erythropoiesis-stimulating agents is a therapeutic challenge in many patients . NAC reduces the risk of progression of CKD of any etiology to end stage renal disease (ESRD) but the mechanism by which it reduces the progression of CKD to ESRD is unclear. It may be because of its antioxidant and vasodilatory nature. Prolonged duration of administration and higher dosage of NAC can protect kidneys.

Detailed description

All patients with chronic kidney disease on regular hemodialysis will be enrolled. \- Study location: The patients will be recruited from pediatric nephrology department, Cairo University Children's Hospital and Beni Suef University. History taking including the age, sex, primary cause of CKD, onset of hemodialysis, medications including erythropoietin dose, frequency, and duration, oral or intravenous iron therapy, and frequency of blood transfusion. Clinical examination focusing on pallor, blood pressure, and anthropometric measurements and their percentile. Investigations including hemoglobin level at the start of the study and every month during the study period, serum ferritin, alanine aminotransferase, total oxidative stress (TOS), total antioxidant capacity (TAC), and oxidative stress index (OSI) at the start and after 3 months of the onset of the study. Patients will receive N-acetyl cysteine (10 mg/kg/day, orally). The duration of the study will 3 months.

Conditions

• Chronic Kidney Diseases

Interventions

Type	Name	Description
DRUG	N-acetyl cysteine	mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-06-01
• Completion: 2023-01-01
• First posted: 2021-06-07
• Last updated: 2023-04-11

Locations

2 sites across 1 country: Egypt