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

Renal Transplantation Clinical Trial

Official title:

Calcineurin Inhibitors Among Egyptian Renal Transplant Patients: a Pharmacognetic Based Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03830255
• Other study ID #: FWA000017585
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: March 29, 2020

Study information

• Verified date: March 2021
• Source: Helwan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 143
• Est. completion date: March 29, 2020
• Est. primary completion date: October 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Transplantation

Locations

Country	Name	City	State
Egypt	Ain shams university specialized hospital	Cairo

Sponsors (2)

Lead Sponsor	Collaborator
Helwan University	Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CYP enzymes genetic polymorphism and calcineurin inhibitors drug levels	Association of CP3A4 and CYP3A5 genetic polymorphism SNPs on Cyclosporine and Tacrolimus blood concentration	3 months