Chronic Kidney Disease Patient in Chronic Myloied Leukemia

Chronic Myeloid Leukemia in Remission Clinical Trial

Official title:

Chronic Kidney Disease Patient in Chronic Myloied Leukemia

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06266975
• Other study ID #: CKD pts in CML
• Status: Not yet recruiting
• Start date: February 2024
• Est. completion date: November 2026

Study information

• Verified date: February 2024
• Source: Assiut University
• Contact: sahar mohamed gad, third
• Phone: 01007531866
• Email: sahargad22397[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia .

Description:

- Chronic myeloid leukemia (CML) is a cancer of bone marrow that leads to an increased number of white blood cells. CML is more prevalent in the elderly and is characterized by weight loss, tiredness, shortness of breath, excessive sweating, bone pain, and frequent infections. [1] According to the American Cancer Society's estimates, CML represents 15% of all new leukemia cases.[2] The global burden of disease (GBD) study 2015 revealed that leukemia was under the top ten leading causes of death globally.[3] However, the latest GBD study found a decrease in the age-standardized incidence rate and the death rate from 1990-2017.[4] This dramatic improvement in the overall survival and health-related quality of life among CML patients was attributed to the impact of new therapeutic strategies. Tyrosine kinase inhibitors (TKIs), particularly imatinib, emerged as a potential therapeutic agent for the treatment of CML, reducing epidemiological burden (incidence rate), and improve quality of life.[5] - The definition and classification of chronic kidney disease (CKD) have evolved over time, but current international guidelines define this condition as decreased kidney function shown by glomerular filtration rate (GFR) of less than 60 mL/min per 1•73 m2, or markers of kidney damage, or both, of at least 3 months duration, regardless of the underlying cause[6] Diagnosis is commonly made after chance findings from screening tests (urinary dipstick or blood tests), or when symptoms become severe. The best available indicator of overall kidney function is GFR, which is measured either via exogenous markers (eg, DTPA, iohexol), or estimated using equations. Presence of proteinuria is associated with increased risk of progression of CKD and death. Presence of proteinuria is associated with increased risk of progression of CKD and death.[7,8] Kidney biopsy samples can show definitive evidence of CKD, through common changes such as glomerular sclerosis, tubular atrophy, and interstitial fibrosis. Complications include anaemia due to reduced production of erythropoietin by the kidney; reduced red blood cell survival and iron deficiency; and mineral bone disease caused by disturbed vitamin D, calcium, and phosphate metabolism.[9

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: November 2026
• Est. primary completion date: November 2026
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:1_ Chronic myloid leukemia patiants who diagonised by biopsy , 2_ CBC. - Exclusion : 1_pts known to have CKD before diagnosed of CML. 2- known Diabetic pts 3-imaging suggestive CKD etiology rather than CML effect eg.PKD,renal stones,chronic pyelonephritis

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia in Remission
• Kidney Diseases
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Renal Insufficiency, Chronic

Intervention

Device:
• Biobsy from kidney
using tyrosine kinase inhibitors particulary imatinib in ttt CML patients

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sahar Mohammed Gad

References & Publications (2)

Fathallah-Shaykh SA, Flynn JT, Pierce CB, Abraham AG, Blydt-Hansen TD, Massengill SF, Moxey-Mims MM, Warady BA, Furth SL, Wong CS. Progression of pediatric CKD of nonglomerular origin in the CKiD cohort. Clin J Am Soc Nephrol. 2015 Apr 7;10(4):571-7. doi: 10.2215/CJN.07480714. Epub 2015 Jan 29. — View Citation

Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic Kidney Disease Patient in Chronic Myloied Leukemia	Using Non Invasive or invasive Methods and correlation between lab and radiological methods to find and a relation between CML and CKD and outcome.	basline