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

Phase 2

Completed

• Conditions: Chronic Kidney Diseases
• Interventions: Drug: N-acetyl cysteine

• Registration Number: NCT04916080
• Lead Sponsor: Beni-Suef University

Brief 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.

Study Timeline

• Study First Submitted: 2021-04-30
• Study First Submitted QC: 2021-06-04
• Study First Posted: 2021-06-07
• Study Start: 2021-11-01
• Primary Completion: 2022-06-01
• Study Completion: 2023-01-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-09
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• pediatric patients with chronic kidney diseases stage 3, 4 or 5

Exclusion Criteria

• Unwilling to participate in the study.

• non-compliant patients on the standard care of CKD.

  • Patients with cardiac, endocrinal, and hepatic complications.
  • Asthma or known allergy to NAC.
  • Any chronic infections prior to or during the study period.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
after treatment	N-acetyl cysteine	chronic kidney disease patients after receiving NAC for 3 months

Primary Outcome Measures

Name	Time	Method
left ventricular function	3 months	rate of change of left ventricular functions before and after treatment by electrocardiography
hemoglobin (gm%)	3 months	the change in levels of hemoglobin after treatment
oxidative status	3 months	rate of change of total oxidative status after treatment using ELISA kits
serum Ferritin level (mg/dl)	3 months	the change in levels of d ferritin after treatment using specific kits
Anti-oxidative status	3 months	rate of change of anti oxidant capacity after treatment

Secondary Outcome Measures

Name	Time	Method
serious side effects	3 months	elevation of ALT levels

Trial Locations

Locations (2)

Beni-Suef university hospital; 🇪🇬 Banī Suwayf, Egypt

Pediatric nephrology and transplantation unite.Aboelrish children hospital; 🇪🇬 Cairo, Egypt