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

Primary Purpose

Chronic Kidney Diseases

Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
N-acetyl cysteine
Sponsored by
Beni-Suef University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Diseases

Eligibility Criteria

6 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Beni-Suef university hospital
  • Pediatric nephrology and transplantation unite.Aboelrish children hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

after treatment

Arm Description

chronic kidney disease patients after receiving NAC for 3 months

Outcomes

Primary Outcome Measures

hemoglobin (gm%)
the change in levels of hemoglobin after treatment
oxidative status
rate of change of total oxidative status after treatment using ELISA kits
left ventricular function
rate of change of left ventricular functions before and after treatment by electrocardiography
serum Ferritin level (mg/dl)
the change in levels of d ferritin after treatment using specific kits
Anti-oxidative status
rate of change of anti oxidant capacity after treatment

Secondary Outcome Measures

serious side effects
elevation of ALT levels

Full Information

First Posted
April 30, 2021
Last Updated
April 9, 2023
Sponsor
Beni-Suef University
Collaborators
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04916080
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
June 1, 2022 (Actual)
Study Completion Date
January 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef University
Collaborators
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
after treatment
Arm Type
Experimental
Arm Description
chronic kidney disease patients after receiving NAC for 3 months
Intervention Type
Drug
Intervention Name(s)
N-acetyl cysteine
Other Intervention Name(s)
NAC
Intervention Description
mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally
Primary Outcome Measure Information:
Title
hemoglobin (gm%)
Description
the change in levels of hemoglobin after treatment
Time Frame
3 months
Title
oxidative status
Description
rate of change of total oxidative status after treatment using ELISA kits
Time Frame
3 months
Title
left ventricular function
Description
rate of change of left ventricular functions before and after treatment by electrocardiography
Time Frame
3 months
Title
serum Ferritin level (mg/dl)
Description
the change in levels of d ferritin after treatment using specific kits
Time Frame
3 months
Title
Anti-oxidative status
Description
rate of change of anti oxidant capacity after treatment
Time Frame
3 months
Secondary Outcome Measure Information:
Title
serious side effects
Description
elevation of ALT levels
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Beni-Suef university hospital
City
Banī Suwayf
ZIP/Postal Code
65211
Country
Egypt
Facility Name
Pediatric nephrology and transplantation unite.Aboelrish children hospital
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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

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