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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Diseases
• Intervention / Treatment: Drug: N-acetyl cysteine

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Yasmin M Eissawy, MD; Phone Number: +201205551868; Email: yasminramadan@kasralainy.edu.eg
• Study Contact Backup: Name: Heba M Ahmed; Phone Number: +201001516641; Email: heba_most@yahoo.com

Study Locations

• Egypt
  • Banī Suwayf, Egypt, 65211
    • Beni-Suef University hospital
  • Cairo, Egypt
    • Pediatric nephrology and transplantation unite.Aboelrish children hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: after treatment; chronic kidney disease patients after receiving NAC for 3 months	Drug: N-acetyl cysteine; mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally; Other Names: NAC

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serious side effects	elevation of ALT levels	3 months

Collaborators and Investigators

• Sponsor: Beni-Suef University
• Collaborators: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): January 1, 2023

Study Registration Dates

• First Submitted: April 30, 2021
• First Submitted That Met QC Criteria: June 4, 2021
• First Posted (Actual): June 7, 2021

Study Record Updates

• Last Update Posted (Actual): April 11, 2023
• Last Update Submitted That Met QC Criteria: April 9, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: FMBSUREC. FWA00015574

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No