NCT06392425

Brief Summary

  1. 1.To evaluate clinical utility of Serum ADAM 17 (A disintegrin and metalloprotease 17) and Caspase 3 measurement in chronic kidney disease patients
  2. 2.Study relationship of serum ADAM 17 and Caspase 3 to stages of chronic kidney disease
  3. 3.Compare serum ADAM 17 and Caspase 3 levels in Diabetic Chronic kidney disease patients and Non Diabetic Chronic kidney disease patients

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
15mo left

Started Apr 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Apr 2024Oct 2027

First Submitted

Initial submission to the registry

April 26, 2024

Completed
Same day until next milestone

Study Start

First participant enrolled

April 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 30, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2027

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2027

Last Updated

May 1, 2024

Status Verified

April 1, 2024

Enrollment Period

2.9 years

First QC Date

April 26, 2024

Last Update Submit

April 30, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    baseline

Study Arms (6)

- Group (1): stage(1) CKD patient group

Stage 1 of CKD (eGFR of 90 or greater)

Other: caspase 3 and ADAM 17 biomarkers

-Group (2): stage (2) CKD patient group

Stage 2 of CKD (eGFR between 60 and 89)

Other: caspase 3 and ADAM 17 biomarkers

-Group (3) :stage(3) CKD patient group

Stage 3 of CKD (eGFR between 30 and 59)

Other: caspase 3 and ADAM 17 biomarkers

-Group (4) :stage (4) CKD patient group

Stage 4 of CKD (eGFR between 15 and 29)

Other: caspase 3 and ADAM 17 biomarkers

-Group (5):stage(5) CKD patient group

Stage 5 of CKD (eGFR less than 15)

Other: caspase 3 and ADAM 17 biomarkers

-Group (6) :control Group

apparently healthy individuals with matched age and sex are included in this study as a control group for comparison

Other: caspase 3 and ADAM 17 biomarkers

Interventions

Role of caspase 3 and ADAM 17 biomarkers in chronic kidney disease

- Group (1): stage(1) CKD patient group-Group (2): stage (2) CKD patient group-Group (3) :stage(3) CKD patient group-Group (4) :stage (4) CKD patient group-Group (5):stage(5) CKD patient group-Group (6) :control Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with chronic kidney disease with different contributing factors e.g Diabetis mellitus , Hypertension,autoimmune diseases.

You may qualify if:

  • Patients with chronic kidney disease
  • Patients with different contributing factors e.g Diabetis mellitus, Hypertension ,autoimmune diseases.

You may not qualify if:

  • Patients with pulmonary oedema or hepatic disease .
  • Patients with known any organ malignancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 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.

    PMID: 28434650BACKGROUND
  • Iino Y. [Definition of CKD and classification of CKD stage]. Nihon Rinsho. 2008 Sep;66(9):1645-9. Japanese.

    PMID: 18788389BACKGROUND
  • 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.

    PMID: 26553517BACKGROUND
  • 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.

    PMID: 20184396BACKGROUND
  • 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.

    PMID: 30102333BACKGROUND
  • 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.

    PMID: 37685683BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Caspase 3

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Caspases, EffectorCaspasesCysteine EndopeptidasesCysteine ProteasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesEndopeptidasesApoptosis Regulatory ProteinsIntracellular Signaling Peptides and ProteinsProteinsAmino Acids, Peptides, and Proteins

Study Officials

  • samar salah

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

April 26, 2024

First Posted

April 30, 2024

Study Start

April 26, 2024

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

October 31, 2027

Last Updated

May 1, 2024

Record last verified: 2024-04