Chronic Kidney DiseasesPhase 2NCT04916080
N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
A Phase 2 study testing N-acetyl cysteine in people with Chronic Kidney Diseases, run by Beni-Suef University at 2 sites in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- N-acetyl cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Nov 2021to 1 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- pediatric patients with chronic kidney diseases stage 3, 4 or 5
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Beni-Suef university hospital
Banī Suwayf, 65211
Pediatric nephrology and transplantation unite.Aboelrish children hospital
Cairo
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases
- Being tested
- N-acetyl cysteine
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-acetyl cysteineDrug
Also called NAC
mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally
| Study group | Role | What they receive |
|---|---|---|
| after treatment | Experimental | chronic kidney disease patients after receiving NAC for 3 months Receives: Drug: N-acetyl cysteine |
What is being measured
The primary outcome is the main question the study is designed to answer.
hemoglobin (gm%)
the change in levels of hemoglobin after treatment
Measured: 3 months
oxidative status
rate of change of total oxidative status after treatment using ELISA kits
Measured: 3 months
left ventricular function
rate of change of left ventricular functions before and after treatment by electrocardiography
Measured: 3 months
serum Ferritin level (mg/dl)
the change in levels of d ferritin after treatment using specific kits
Measured: 3 months
Anti-oxidative status
rate of change of anti oxidant capacity after treatment
Measured: 3 months
Secondary outcomes (1)
serious side effects
elevation of ALT levels
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2021
- Study start1 Nov 2021
- Primary completion1 Jun 2022
- Study completion1 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Principal investigator, Heba Mostafa Ahmed, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04916080
- Sponsor's protocol ID
- FMBSUREC. FWA00015574
- Status last verified
- Apr 2023
- First submitted
- 30 Apr 2021
- Last updated
- 11 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- N-acetyl Cysteine: the Effectiveness and Safety in a Cohort of Pediatric Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT04916080
- Acronym / sponsor ID
- FMBSUREC. FWA00015574
- Conditions
- Chronic Kidney Diseases
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jan 2023 (actual)
- First posted
- 7 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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
| Arm | Type | Receives |
|---|---|---|
| after treatment | Experimental | Drug: N-acetyl cysteinechronic kidney disease patients after receiving NAC for 3 months |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- pediatric patients with chronic kidney diseases stage 3, 4 or 5
Key exclusion criteria (5 listed)
- Unwilling to participate in the study.
- non-compliant patients on the standard care of CKD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-acetyl cysteineAlso: NACmucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally | Drug | after treatment |
Primary outcome
hemoglobin (gm%)
Time frame: 3 months
the change in levels of hemoglobin after treatment
oxidative status
Time frame: 3 months
rate of change of total oxidative status after treatment using ELISA kits
left ventricular function
Time frame: 3 months
rate of change of left ventricular functions before and after treatment by electrocardiography
serum Ferritin level (mg/dl)
Time frame: 3 months
the change in levels of d ferritin after treatment using specific kits
Anti-oxidative status
Time frame: 3 months
rate of change of anti oxidant capacity after treatment
1 secondary outcome
serious side effects
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-acetyl cysteine in people with Chronic Kidney Diseases, run by Beni-Suef University at 2 sites in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hemoglobin (gm%) (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2023.