Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01686191

Enrollment

300

Registered

2012-09-17

Start date

2012-08-31

Completion date

2025-12-31

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Renal Insufficiency, Heart Transplantation

Keywords

heart transplantation, chronic renal insufficiency, pharmacogenomics, cyclosporine, tacrolimus

Brief summary

Kidney disease is a common problem after heart transplantation. It may be caused by anti-rejection medications such as cyclosporine or tacrolimus. However, the reason why some people develop kidney problems after a heart transplant, but other people do not, is not fully known. This study plans to learn more about the relationship between a person's genetic make-up (DNA; deoxyribonucleic acid) and the risk of kidney problems after a heart transplant. The long-term goal of this research is to identify genetic variations that may help predict the development of kidney problems after heart transplantation.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* cardiac-only transplant * 18 years of age or older at the time of cardiac transplant * 1 year or more post-cardiac transplant * treatment with cyclosporine or tacrolimus following transplant

Exclusion criteria

* combined organ transplant * decisionally impaired * unable to read or speak English * unable or unwilling to provide written informed consent

Design outcomes

Primary

Measure	Time frame
Chronic renal dysfunction	year 2 post-transplant

Countries

United States

Outcome results