- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06266975
Chronic Kidney Disease Patient in Chronic Myloied Leukemia
February 16, 2024 updated by: Sahar Mohammed Gad
To study the Prevalence ,Characteristics and outcome of CKD in patiants with chronic myeloid leukemia .
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed 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
Study Type
Observational
Enrollment (Estimated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: sahar mohamed gad, third
- Phone Number: 01007531866
- Email: sahargad22397@gmail.com
Study Contact Backup
- Name: Mohamad Ramadan Abd_Elhamied, first
- Phone Number: 01097510010
- Email: drmuhamadramadan@yahoo.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
all sexes , adult , not diabetic , not known CKD before diagnosed of CML
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Chronic Kidney Disease Patient in Chronic Myloied Leukemia
Time Frame: basline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ahmed Ramadan, Assist
- Study Director: Mohamed Ramadan, Assiut University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
February 1, 2024
Primary Completion (Estimated)
November 1, 2026
Study Completion (Estimated)
November 1, 2026
Study Registration Dates
First Submitted
November 3, 2023
First Submitted That Met QC Criteria
February 16, 2024
First Posted (Actual)
February 20, 2024
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 16, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Diseases
- Disease Attributes
- Bone Marrow Diseases
- Hematologic Diseases
- Renal Insufficiency
- Myeloproliferative Disorders
- Leukemia, Myeloid
- Chronic Disease
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Kidney Diseases
- Renal Insufficiency, Chronic
- Leukemia
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Protein Kinase Inhibitors
- Tyrosine Protein Kinase Inhibitors
Other Study ID Numbers
- CKD pts in CML
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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