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NCT Number: NCT04916080

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.

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Key information

Conditions

Chronic Kidney Diseases Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

6 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beni-Suef university hospital, Banī Suwayf, Egypt

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

N-acetyl cysteine

Drug

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

Other names: NAC

Primary outcomes

  1. hemoglobin (gm%)

    Time frame: 3 months

    the change in levels of hemoglobin after treatment

  2. oxidative status

    Time frame: 3 months

    rate of change of total oxidative status after treatment using ELISA kits

  3. left ventricular function

    Time frame: 3 months

    rate of change of left ventricular functions before and after treatment by electrocardiography

  4. serum Ferritin level (mg/dl)

    Time frame: 3 months

    the change in levels of d ferritin after treatment using specific kits

  5. Anti-oxidative status

    Time frame: 3 months

    rate of change of anti oxidant capacity after treatment

Secondary outcomes

  1. serious side effects

    Time frame: 3 months

    elevation of ALT levels

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Collaborators

  • Cairo University

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Jun 7, 2021
Registry last updated
Apr 11, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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