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

NCT ID: NCT04916080

Last Updated: 2023-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2023-01-01

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.

Conditions

Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

after treatment

chronic kidney disease patients after receiving NAC for 3 months

Group Type: EXPERIMENTAL

N-acetyl cysteine

Intervention Type: DRUG

mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally

Interventions

N-acetyl cysteine

mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally

Intervention Type: DRUG

Other Intervention Names

NAC

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: collaborator

Beni-Suef University

OTHER

Sponsor Role: lead

Responsible Party

Heba Mostafa Ahmed

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Beni-Suef university hospital

Banī Suwayf, , Egypt

Pediatric nephrology and transplantation unite.Aboelrish children hospital

Cairo, , Egypt

Countries

Egypt

Other Identifiers

FMBSUREC. FWA00015574

Identifier Type: -

Identifier Source: org_study_id