COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Genetic Predictors of Renal Dysfunction Following Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01686191
Recruitment Status : Active, not recruiting
First Posted : September 17, 2012
Last Update Posted : January 22, 2020
National Jewish Health
Information provided by (Responsible Party):
University of Colorado, Denver

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.

Condition or disease
Heart Transplantation Chronic Renal Insufficiency

Layout table for study information
Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation
Actual Study Start Date : August 2012
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Cardiac transplant recipients

Primary Outcome Measures :
  1. Chronic renal dysfunction [ Time Frame: year 2 post-transplant ]

Biospecimen Retention:   Samples With DNA
Buccal cell and blood sample for genomic DNA

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Cardiac transplant clinic

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

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 identifier (NCT number): NCT01686191

Layout table for location information
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Jewish Health
Layout table for investigator information
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver
Layout table for additonal information
Responsible Party: University of Colorado, Denver Identifier: NCT01686191    
Other Study ID Numbers: 12-0869
12GRNT12040211 ( Other Grant/Funding Number: American Heart Association )
First Posted: September 17, 2012    Key Record Dates
Last Update Posted: January 22, 2020
Last Verified: January 2020
Keywords provided by University of Colorado, Denver:
heart transplantation
chronic renal insufficiency
Additional relevant MeSH terms:
Layout table for MeSH terms
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases