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

Chronic Kidney Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04916080
• Other study ID #: FMBSUREC. FWA00015574
• Status: Completed
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: January 1, 2023

Study information

• Verified date: April 2023
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: January 1, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Months to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Diseases
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• N-acetyl cysteine
mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally

Locations

Country	Name	City	State
Egypt	Beni-Suef university hospital	Bani Suwayf
Egypt	Pediatric nephrology and transplantation unite.Aboelrish children hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Beni-Suef University	Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hemoglobin (gm%)	the change in levels of hemoglobin after treatment	3 months
Primary	oxidative status	rate of change of total oxidative status after treatment using ELISA kits	3 months
Primary	left ventricular function	rate of change of left ventricular functions before and after treatment by electrocardiography	3 months
Primary	serum Ferritin level (mg/dl)	the change in levels of d ferritin after treatment using specific kits	3 months
Primary	Anti-oxidative status	rate of change of anti oxidant capacity after treatment	3 months
Secondary	serious side effects	elevation of ALT levels	3 months