- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06392425
Role of Serum ADAM 17 (A Disintegrin And Metalloprotease 17) and Caspase 3 in Patients With Chronic Kidney Disease
April 30, 2024 updated by: samar salah eldin abdelrahman, Assiut University
- To evaluate clinical utility of Serum ADAM 17 (A disintegrin and metalloprotease 17) and Caspase 3 measurement in chronic kidney disease patients
- Study relationship of serum ADAM 17 and Caspase 3 to stages of chronic kidney disease
- Compare serum ADAM 17 and Caspase 3 levels in Diabetic Chronic kidney disease patients and Non Diabetic Chronic kidney disease patients
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Kidney diseases represent a global public health problem ,It is estimated that 10-15% of the population is affected by Chronic kidney disease.(1)
Chronic kidney disease (CKD) is defined by persistent urine and structural abnormalities or impaired excretory renal function ( an estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73
m2, persisting for three months or more suggestive of a loss of functional nephrons) (2) the most common contributing factors to CKD include genetic abnormalities and ageing, while the most common underlying diseases associated with CKD are diabetes and hypertension However, CKD can be also due to infectious diseases, autoimmune diseases (such as lupus), and medications (3) A disintegrin and metalloproteinase (ADAM) 17, also known as tumour necrosis factor α-converting enzyme (TACE), is a metalloproteinase that releases the ectodomains of most growth factors, cytokines, receptors and enzymes and has been associated with the presence of chronic kidney disease (5) Clinical and experimental studies have shown that ADAM17 is involved in chronic kidney disease (CKD) with a proinflammatory and profibrotic role, suggesting that it could be an important mediator of CKD progression.
ADAM17 inhibition attenuates fibrosis and inflammation, suggesting that its inhibition may be a possible new valuable therapeutic tool in fibrotic kidney disease treatment(6) Caspases (cysteine aspartases, cysteine-aspartic proteases) are protease enzymes which play a role in apoptotic pathway.
Their name derives from their specific cysteine protease activity .
Most cells have caspases in an inactive proenzyme form, which is activated and induces other pro-caspases, thus initiating a protease cascade.
This process is able to amplify the apoptotic signaling pathway and to induce rapid cell death, ,Caspase-3 plays a dominant role in apoptosis, involved in the pathogenesis and progression of chronic kidney disease (CKD).(7)
Study Type
Observational
Enrollment (Estimated)
90
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: samar salah
- Phone Number: 01002753465
- Email: samarsalah24194@gmail.com
Study Contact Backup
- Name: Eman Mohammed
- Phone Number: 01003030752
- Email: Dr.emanmohammed@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
Patients with chronic kidney disease with different contributing factors e.g Diabetis mellitus , Hypertension,autoimmune diseases.
Description
Inclusion Criteria:
- Patients with chronic kidney disease
- Patients with different contributing factors e.g Diabetis mellitus, Hypertension ,autoimmune diseases.
Exclusion Criteria:
- Patients with pulmonary oedema or hepatic disease .
- Patients with known any organ malignancy.
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
-Group (6) :control Group
apparently healthy individuals with matched age and sex are included in this study as a control group for comparison
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
- Group (1): stage(1) CKD patient group
Stage 1 of CKD (eGFR of 90 or greater)
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
-Group (2): stage (2) CKD patient group
Stage 2 of CKD (eGFR between 60 and 89)
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
-Group (3) :stage(3) CKD patient group
Stage 3 of CKD (eGFR between 30 and 59)
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
-Group (4) :stage (4) CKD patient group
Stage 4 of CKD (eGFR between 15 and 29)
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
-Group (5):stage(5) CKD patient group
Stage 5 of CKD (eGFR less than 15)
|
Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To evaluate clinical utility of Serum ADAM 17 (A disintegrin and metalloprotease 17) and Caspase 3 measurement in chronic kidney disease patients
Time Frame: baseline
|
Study relationship of serum ADAM 17 and Caspase 3 to stages of chronic kidney disease
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: samar salah, 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
- Levin A, Tonelli M, Bonventre J, Coresh J, Donner JA, Fogo AB, Fox CS, Gansevoort RT, Heerspink HJL, Jardine M, Kasiske B, Kottgen A, Kretzler M, Levey AS, Luyckx VA, Mehta R, Moe O, Obrador G, Pannu N, Parikh CR, Perkovic V, Pollock C, Stenvinkel P, Tuttle KR, Wheeler DC, Eckardt KU; ISN Global Kidney Health Summit participants. Global kidney health 2017 and beyond: a roadmap for closing gaps in care, research, and policy. Lancet. 2017 Oct 21;390(10105):1888-1917. doi: 10.1016/S0140-6736(17)30788-2. Epub 2017 Apr 20.
- Iino Y. [Definition of CKD and classification of CKD stage]. Nihon Rinsho. 2008 Sep;66(9):1645-9. Japanese.
- Thomas MC, Cooper ME, Zimmet P. Changing epidemiology of type 2 diabetes mellitus and associated chronic kidney disease. Nat Rev Nephrol. 2016 Feb;12(2):73-81. doi: 10.1038/nrneph.2015.173. Epub 2015 Nov 10.
- Gooz M. ADAM-17: the enzyme that does it all. Crit Rev Biochem Mol Biol. 2010 Apr;45(2):146-69. doi: 10.3109/10409231003628015.
- Palau V, Riera M, Duran X, Valdivielso JM, Betriu A, Fernandez E, Pascual J, Soler MJ. Circulating ADAMs are associated with renal and cardiovascular outcomes in chronic kidney disease patients. Nephrol Dial Transplant. 2020 Jan 1;35(1):130-138. doi: 10.1093/ndt/gfy240. Erratum In: Nephrol Dial Transplant. 2020 Sep 1;35(9):1642.
- Clementi A, Virzi GM, Manani SM, de Cal M, Battaglia GG, Ronco C, Zanella M. Plasma Cell-Free DNA and Caspase-3 Levels in Patients with Chronic Kidney Disease. J Clin Med. 2023 Aug 28;12(17):5616. doi: 10.3390/jcm12175616.
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)
April 26, 2024
Primary Completion (Estimated)
March 31, 2027
Study Completion (Estimated)
October 31, 2027
Study Registration Dates
First Submitted
April 26, 2024
First Submitted That Met QC Criteria
April 26, 2024
First Posted (Actual)
April 30, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- caspase 3 and ADAM 17 in CKD
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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