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Trial record 59 of 573 for:    Genetic AND SNP

Effect of Genetic Polymorphism on Calcineurin Inhibitors Levels in Egyptian Renal Transplant Patients

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ClinicalTrials.gov Identifier: NCT03830255
Recruitment Status : Recruiting
First Posted : February 5, 2019
Last Update Posted : February 5, 2019
Sponsor:
Collaborator:
Ain Shams University
Information provided by (Responsible Party):
Dina Ahmed Mohamed Ali Ismail, Misr International University

Brief Summary:

Renal transplantation is the treatment of choice for patients with end-stage renal disease (ESRD). Calcineurin Inhibitors tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejection.

The aim of the present study is to detect the incidence of some selected genetic polymorphism in Egyptian renal transplant population and investigate the influence of these genetic polymorphism (SNPs )on Cyclosporine and Tacrolimus blood concentration. In addition to detect the association between these genetic polymorphism variants and patients' clinical outcome after transplantation.


Condition or disease
Renal Transplantation

Detailed Description:
Tacrolimus and cyclosporine are the principle immunosuppressive agents administered to solid organ transplant recipients to prevent and treat allograft rejection.They both exert their immunosppressive action by inhibiting the calcinurein in T-lymphoctes. Subsequently,Cyclosporin and tacrolimus are both metabolic substrates for cytochrome P450 (CYP) 3A enzymes - in particular, CYP3A4 and CYP3A5 - and are transported out of cells by the P-glycoprotein (ABCB1) efflux pump. Different expression of CYP3A4, CYP3A5 and P-glycoprotein causes patient to-patient variability in the absorption, metabolism and tissue distribution of calcineurin inhibitors. This different expression is likely to be at least partially the result of mutations in the genes encoding for these enzymes and drug transporter. This may lead to variable drug concentrations within the systemic circulation and at target sites, influencing drug efficacy. Moreover, it will influence the individual's susceptibility to drug interactions and drug toxicity

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Study Type : Observational
Estimated Enrollment : 130 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Calcineurin Inhibitors Among Egyptian Renal Transplant Patients: a Pharmacognetic Based Study.
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Group/Cohort
Renal Transplant patients treated with cyclosporin
Renal Transplant patients treated with tacrolimus



Primary Outcome Measures :
  1. CYP enzymes genetic polymorphism and calcineurin inhibitors drug levels [ Time Frame: 3 months ]
    Association of CP3A4 and CYP3A5 genetic polymorphism SNPs on Cyclosporine and Tacrolimus blood concentration


Biospecimen Retention:   Samples With DNA
Peripheral blood samples will be collected and stored in - 80°C environment for DNA extraction by DNA extraction kit according to manufacturer recommendation


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Renal Transplant Patients
Criteria

Inclusion Criteria:

  1. Kidney transplant patients.
  2. Treatment with calcineurin inhibitors (CNI) either Cyclosporine (Neoral®) or Tacrolimus (Prograf®).
  3. Absence of medication known to interact with CNI
  4. Age18 years and more

Exclusion Criteria:

  1. Patient who experience acute rejection, graft failure.
  2. Medications that interact with Calcineurin Inhibitors.
  3. Pregnant or nursing women.
  4. Patients who decline to participate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03830255


Contacts
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Contact: Dina Ahmed, Msc 00201066063333 dina1ahmed@hotmail.com
Contact: Magdy El Sharkawy, MD 00201001422331 magdi35@hotmail.com

Locations
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Egypt
Ain shams university specialized hospital Recruiting
Cairo, Egypt
Contact: Dina Ahmed, Msc    00201066063333    dina1ahmed@hotmail.com   
Contact: Magdy El sharkawy, MD    00201001422331    Magdi35@hotmail.com   
Sponsors and Collaborators
Helwan University
Ain Shams University
Investigators
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Principal Investigator: Magdy El Sharkawy, MD Ain Shams University
Study Director: Abdel hameed Ibrahim Mohamed Ebid, PhD Helwan University
Study Director: Neama Lotfy, MD Ain sham university
Study Director: Mohamed Adel, PhD Helwan University

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Responsible Party: Dina Ahmed Mohamed Ali Ismail, Lecturer Assistant at Clinical Pharmacy and Pharmacy Practice department, Misr International University
ClinicalTrials.gov Identifier: NCT03830255     History of Changes
Other Study ID Numbers: FWA000017585
First Posted: February 5, 2019    Key Record Dates
Last Update Posted: February 5, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dina Ahmed Mohamed Ali Ismail, Misr International University:
Renal Transplantation
Genetic Polymorphism
CP3A5
CYP3A4

Additional relevant MeSH terms:
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Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action