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

NCT04916080 | Completed Phase 2

• 1 other identifier: FMBSUREC. FWA00015574
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Kidney Diseases

Outcome Measures

Primary Outcomes (5)

• hemoglobin (gm%)

  the change in levels of hemoglobin after treatment

  3 months

• oxidative status

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

  3 months

• left ventricular function

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

  3 months

• serum Ferritin level (mg/dl)

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

  3 months

• Anti-oxidative status

  rate of change of anti oxidant capacity after treatment

  3 months

Secondary Outcomes (1)

• serious side effects

  3 months

Study Arms (1)

after treatment

EXPERIMENTAL

chronic kidney disease patients after receiving NAC for 3 months

Drug: N-acetyl cysteine

Interventions

N-acetyl cysteine DRUG

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

Also known as: NAC

after treatment

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• pediatric patients with chronic kidney diseases stage 3, 4 or 5

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beni-Suef University: lead
• Cairo University: collaborator

Study Sites (2)

Beni-Suef university hospital

Banī Suwayf, 65211, Egypt

Location

Pediatric nephrology and transplantation unite.Aboelrish children hospital

Cairo, Egypt

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Model Details: 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

Study Record Dates

• First Submitted: April 30, 2021
• First Posted: June 7, 2021
• Study Start: November 1, 2021
• Primary Completion: June 1, 2022
• Study Completion: January 1, 2023
• Last Updated: April 11, 2023

Record last verified: 2023-04

Locations

EG (2)