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

NCT04916080 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2023-04-11

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases

Interventions

DRUG

N-acetyl cysteine

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

Sponsors & Collaborators

  • Cairo University

    collaborator OTHER

  • Beni-Suef University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2022-06-01
Completion
2023-01-01

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04916080 on ClinicalTrials.gov