CKDNCT06143098
Some Hematological Profile in Children With Chronic Kidney Disease
An observational study of CKD and Hematological Disease, run by Assiut University.
Trial summary
This study is asses the hematological changes in children with chronic kidney disease stage 3 to 5 including Complete blood picture Coagulation profile (PT, PC, PTT) Iron study Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- CKD, Hematological Disease
- How many people
- 102 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2024to 31 Jan 2025
- Phase
- Observational
- 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Childen aged 1:18 years with chronic kidney disease stage 3 to 5 (estimated glomerular filteration rate >60 ml/min per 1.73 m2).
Who may be able to join
- Childen aged 1:18 years with chronic kidney disease stage 3 to 5 (estimated glomerular filteration rate >60 ml/min per 1.73 m2).
Who cannot join
- Children >1year.
- Children with chronic kidney disease in stage 1 and 2.
- Children with liver disease.
- Children known blood disorder rather than anemia.
- Children with malignancy.
- Children with recent bleeding tendancy.
Trial locations and contacts
No sites are listed yet.
About this study
This study is asses the hematological changes in children with chronic kidney disease stage 3 to 5 including
- Complete blood picture
- Coagulation profile (PT, PC, PTT)
- Iron study
Read the detailed description
Chronic kidney disease (CKD) is a major public health issue with an increasing incidence and prevalence worldwide. In CKD, hematological parameters are influenced, it is associated with high morbidity and mortality rates, but there have been very few studies on the hematological profile of children with chronic kidney disease, on follow-up in general, and particularly among chronic kidney disease patients(Melaku.,et al 2022).
CKD is defined by the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2, it can last for 3 months or longer, regardless of the cause. Chronic kidney disease (CKD) is recognized as a major non-communicable disease in children. (Inker.,et al2014).
CKD is classifies it into 6 categories based on glomerular filtration rate (G1 to G5 with G3 split into 3a and 3b). It also includes the staging based on three levels of albuminuria (A1, A2, and A3), with each stage of CKD being sub-categorized according to the urinary albumin-creatinine ratio in (mg/gm) or (mg/mmol) in an early morning "spot" urine sample.( Inker,.et al 2012)
The 6 categories include:
- G1: GFR 90 ml/min per 1.73 m2 and above
- G2: GFR 60 to 89 ml/min per 1.73 m2
- G3a: GFR 45 to 59 ml/min per 1.73 m2
- G3b: GFR 30 to 44 ml/min per 1.73 m2
- G4: GFR 15 to 29 ml/min per 1.73 m2
- G5: GFR less than 15 ml/min per 1.73 m2 or treatment by dialysis The three levels of albuminuria include an albumin-creatinine ratio (ACR)
- A1: ACR less than 30 mg/gm (less than 3.4 mg/mmol)
- A2: ACR 30 to 299 mg/gm (3.4 to 34 mg/mmol)
- A3: ACR greater than 300 mg/gm (greater than 34 mg/mmol). (Inker.,et al2014). hematological parameters such as white blood cell (WBC) include total leukocyte and differential counts, platelet (PLT), and red blood cell (RBC). Parameters, Kidney function ,electrolytes such as Na,k,ca and liver function bleeding time, and pro-thrombin time, are usually affected in CKD . These are common in CKD due to erythropoietin deciency and other factors such as increased hemolysis, suppression of bone marrow erythropoiesis, hematuria, and gastro intestinal blood loss. (George.,et al2015).
All CKD patients, particularly those with an estimated GFR (eGFR) < 60 mL/min/1.73 m2, should be screened for anemia on initial evaluation for CKD. Anemia is defined as Hb < 13 g/dL in men and Hb < 12 g/dL in women, according to WHO criteria. (Hira Shaikh.,et al 2023).
the primary cause of anemia in patients with CKD is insufficient production of erythropoietin by the diseased kidneys. Other factors include iron, folate \& B12 deficiency due to nutritional insufficiency or increased blood loss (Hira Shaikh.,et al 2023). acute and chronic inflammation with impaired iron utilization, sever hyperparathyroidism with consequent bone marrow fibrosis and shortened red cell survival in the uremic environment, bleeding due to dysfunctional platelets, and rarely blood loss from hemodialysis(Hira Shaikh.,et al 2023).
Criteria used to define iron deficiency are different among CKD compared to normal renal function. Among CKD patients, absolut iron deficiency is defined when the transferrin saturation (TSAT) is ≤20% and the serum ferritin concentration is ≤100 ng/mL among predialysis and peritoneal dialysis patients or ≤200 ng/mL among hemodialysis patients. Functional iron deficiency, also known as iron-restricted erythropoiesis, is characterized by TSAT ≤20% and elevated ferritin levels. (TSAT = plasma iron divided by the total iron-binding capacity × 100)( Cappellini .,et al 2017) .
untreated prolonged anemia leads to a number of physiologic disorders, including: cardiovascular complications like decreased tissue oxygenation, increased cardiac output, ventricular dilatation and ventricular hypertrophy and increased mortality and morbidity.( Dwijen Das ., et al 2015).
Iron supplementation is recommended for all CKD patients with anemia. There is general agreement according to guidelines that intravenous (i.v.) iron supplementation is the preferred method for CKD patients on dialysis (CKD stage 5D) and either i.v. or oral iron is recommended for patients with CKD(Tolkien.,et al 2015)
- Conditions
- CKD, Hematological Disease
- Keywords
- CBC in CKD, Iron profile in CKD, Coagulation profile in CKD
- Medical subject headings
- Hematologic Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
descreption and observation in Complete blood count parameters in children with CKD
asses changes in Complete blood count parameter in children with chronic kidney disease stage 3 to 5
Measured: baseline
descreption and observation in iron profile in children with CKD
asses changes in serum ferritin ,serum iron, Trans ferritin saturation and Total iron binding capacity in children with chronic kidney disease stage 3 to 5
Measured: baseline
descreption and observation in coagulation profile in children with CKD
asses changes in prothrombin time, prothrombin concentration, partial thromboplastin time,and international normalized ratio in children with chronic kidney disease stage 3 to 5
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Mar 2024 (estimated)
- Primary completion1 Mar 2024 (estimated)
- Study completion31 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CKDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeinab Othman AbdelGaleel, Assiut University
- Investigators
- Kotb Abbass, professor, Study director, Assiut UniversityAsmaa Ahmed, lecture, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143098
- Sponsor's protocol ID
- hematological profile in CKD
- Status last verified
- Feb 2024
- First submitted
- 14 Nov 2023
- Last updated
- 20 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hashmi MF, Shaikh H, Rout P. Anemia of Chronic Kidney Disease. 2024 Jul 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539871/
PubMed 30969693
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Some Hematological Profile in Children With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT06143098
- Acronym / sponsor ID
- hematological profile in CKD
- Conditions
- CKD, Hematological Disease
- Keywords
- CBC in CKD, Iron profile in CKD, Coagulation profile in CKD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (estimated)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 22 Nov 2023 (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.
This study is asses the hematological changes in children with chronic kidney disease stage 3 to 5 including
- Complete blood picture
- Coagulation profile (PT, PC, PTT)
- Iron study
Detailed description
Chronic kidney disease (CKD) is a major public health issue with an increasing incidence and prevalence worldwide. In CKD, hematological parameters are influenced, it is associated with high morbidity and mortality rates, but there have been very few studies on the hematological profile of children with chronic kidney disease, on follow-up in general, and particularly among chronic kidney disease patients(Melaku.,et al 2022).
CKD is defined by the presence of kidney damage or an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73 m2, it can last for 3 months or longer, regardless of the cause. Chronic kidney disease (CKD) is recognized as a major non-communicable disease in children. (Inker.,et al2014).
CKD is classifies it into 6 categories based on glomerular filtration rate (G1 to G5 with G3 split into 3a and 3b). It also includes the staging based on three levels of albuminuria (A1, A2, and A3), with each stage of CKD being sub-categorized according to the urinary albumin-creatinine ratio in (mg/gm) or (mg/mmol) in an early morning "spot" urine sample.( Inker,.et al 2012)
The 6 categories include:
- G1: GFR 90 ml/min per 1.73 m2 and above
- G2: GFR 60 to 89 ml/min per 1.73 m2
- G3a: GFR 45 to 59 ml/min per 1.73 m2
- G3b: GFR 30 to 44 ml/min per 1.73 m2
- G4: GFR 15 to 29 ml/min per 1.73 m2
- G5: GFR less than 15 ml/min per 1.73 m2 or treatment by dialysis The three levels of albuminuria include an albumin-creatinine ratio (ACR)
- A1: ACR less than 30 mg/gm (less than 3.4 mg/mmol)
- A2: ACR 30 to 299 mg/gm (3.4 to 34 mg/mmol)
- A3: ACR greater than 300 mg/gm (greater than 34 mg/mmol). (Inker.,et al2014). hematological parameters such as white blood cell (WBC) include total leukocyte and differential counts, platelet (PLT), and red blood cell (RBC). Parameters, Kidney function ,electrolytes such as Na,k,ca and liver function bleeding time, and pro-thrombin time, are usually affected in CKD . These are common in CKD due to erythropoietin deciency and other factors such as increased hemolysis, suppression of bone marrow erythropoiesis, hematuria, and gastro intestinal blood loss. (George.,et al2015).
All CKD patients, particularly those with an estimated GFR (eGFR) < 60 mL/min/1.73 m2, should be screened for anemia on initial evaluation for CKD. Anemia is defined as Hb < 13 g/dL in men and Hb < 12 g/dL in women, according to WHO criteria. (Hira Shaikh.,et al 2023).
the primary cause of anemia in patients with CKD is insufficient production of erythropoietin by the diseased kidneys. Other factors include iron, folate \& B12 deficiency due to nutritional insufficiency or increased blood loss (Hira Shaikh.,et al 2023). acute and chronic inflammation with impaired iron utilization, sever hyperparathyroidism with consequent bone marrow fibrosis and shortened red cell survival in the uremic environment, bleeding due to dysfunctional platelets, and rarely blood loss from hemodialysis(Hira Shaikh.,et al 2023).
Criteria used to define iron deficiency are different among CKD compared to normal renal function. Among CKD patients, absolut iron deficiency is defined when the transferrin saturation (TSAT) is ≤20% and the serum ferritin concentration is ≤100 ng/mL among predialysis and peritoneal dialysis patients or ≤200 ng/mL among hemodialysis patients. Functional iron deficiency, also known as iron-restricted erythropoiesis, is characterized by TSAT ≤20% and elevated ferritin levels. (TSAT = plasma iron divided by the total iron-binding capacity × 100)( Cappellini .,et al 2017) .
untreated prolonged anemia leads to a number of physiologic disorders, including: cardiovascular complications like decreased tissue oxygenation, increased cardiac output, ventricular dilatation and ventricular hypertrophy and increased mortality and morbidity.( Dwijen Das ., et al 2015).
Iron supplementation is recommended for all CKD patients with anemia. There is general agreement according to guidelines that intravenous (i.v.) iron supplementation is the preferred method for CKD patients on dialysis (CKD stage 5D) and either i.v. or oral iron is recommended for patients with CKD(Tolkien.,et al 2015)
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Childen aged 1:18 years with chronic kidney disease stage 3 to 5 (estimated glomerular filteration rate >60 ml/min per 1.73 m2).
Key inclusion criteria (1 listed)
- Childen aged 1:18 years with chronic kidney disease stage 3 to 5 (estimated glomerular filteration rate >60 ml/min per 1.73 m2).
Key exclusion criteria (6 listed)
- Children >1year.
- Children with chronic kidney disease in stage 1 and 2.
- Children with liver disease.
- Children known blood disorder rather than anemia.
- Children with malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
descreption and observation in Complete blood count parameters in children with CKD
Time frame: baseline
asses changes in Complete blood count parameter in children with chronic kidney disease stage 3 to 5
descreption and observation in iron profile in children with CKD
Time frame: baseline
asses changes in serum ferritin ,serum iron, Trans ferritin saturation and Total iron binding capacity in children with chronic kidney disease stage 3 to 5
descreption and observation in coagulation profile in children with CKD
Time frame: baseline
asses changes in prothrombin time, prothrombin concentration, partial thromboplastin time,and international normalized ratio in children with chronic kidney disease stage 3 to 5
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
- Background: PubMed 30969693Hashmi MF, Shaikh H, Rout P. Anemia of Chronic Kidney Disease. 2024 Jul 23. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2026 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK539871/
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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.
Kotb Abbass, professor study director
Assiut University
Asmaa Ahmed, lecture study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of CKD and Hematological Disease, run by Assiut University.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zeinab Othman (01280234771, zeinabothman9090@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
descreption and observation in Complete blood count parameters in children with CKD (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06143098, which also lists 1 linked publication.
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 20 Feb 2024.