drugset / Trial / NCT04916080

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

NCT04916080

Phase 2 Completed 50 enrolled Beni-Suef University Cairo University · collab
NaSingle-groupOpen-labelTreatment

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.

Timeline

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

Drugs

EvaluationDrugModalityDoseRoute
Subject N-acetylcysteine Small molecule 10 mg/kg Oral