Clinical trial NCT04916080: N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
Official title: N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Kidney Diseases
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
Collaborators: name: Cairo University
First posted: 2021-06-07
Enrollment: 50
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 50 children with chronic kidney disease will be assessed for iron profile, oxidative stress status and left ventricular functions before and after treatment with N-acetyl cysteine for 3 months
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: hemoglobin (gm%)
timeFrame: 3 months
measure: oxidative status
timeFrame: 3 months
measure: left ventricular function
timeFrame: 3 months
measure: serum Ferritin level (mg/dl)
timeFrame: 3 months
measure: Anti-oxidative status
timeFrame: 3 months
Secondary outcomes:
measure: serious side effects
timeFrame: 3 months
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-Suef university hospital
city: Cairo
country: Egypt
facility: Pediatric nephrology and transplantation unite.Aboelrish children hospital
Study officials:
References: