Genetic Predictors of Renal Dysfunction Following Heart Transplantation

Heart Transplantation Clinical Trial

Official title:

Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01686191
• Other study ID #: 12-0869
• Secondary ID: 12GRNT12040211UL
• Status: Active, not recruiting
• Start date: August 2012
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Renal Insufficiency
• Heart Transplantation
• Renal Insufficiency
• Renal Insufficiency, Chronic

Locations

Country	Name	City	State
United States	University of Colorado Anschutz Medical Campus	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Jewish Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chronic renal dysfunction		year 2 post-transplant