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

NCT03830255 | Completed

• 1 other identifier: FWA000017585
• Study Type: observational
• Target: 143
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Transplantation

Keywords

Renal Transplantation; Genetic Polymorphism; CYP3A5; CYP3A4

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Renal Transplant patients treated with cyclosporine

Detecting the genetic polymorphism affecting cyclosporine level

Renal Transplant patients treated with tacrolimus

Detecting the genetic polymorphism affecting tacrolimus level

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Renal Transplant Patients

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Helwan University: lead
• Ain Shams University: collaborator

Study Sites (1)

Ain shams university specialized hospital

Cairo, Egypt

Location

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

Study Officials

• Magdy El Sharkawy, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

• Abdel hameed Ibrahim Mohamed Ebid, PhD

  Helwan University

  STUDY DIRECTOR

• Neama Lotfy, MD

  Ain sham university

  STUDY DIRECTOR

• Mohamed Adel, PhD

  Helwan University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer Assistant at Clinical Pharmacy and Pharmacy Practice department

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: February 5, 2019
• Study Start: March 1, 2017
• Primary Completion: October 1, 2019
• Study Completion: March 29, 2020
• Last Updated: March 30, 2021

Record last verified: 2021-03

Locations

EG (1)