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Genetic Predictors of Renal Dysfunction Following Heart Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2016 by University of Colorado, Denver
National Jewish Health
Information provided by (Responsible Party):
University of Colorado, Denver Identifier:
First received: September 12, 2012
Last updated: December 14, 2016
Last verified: December 2016
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) 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.

Heart Transplantation
Chronic Renal Insufficiency

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation

Resource links provided by NLM:

Further study details as provided by University of Colorado, Denver:

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

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

Estimated Enrollment: 300
Study Start Date: August 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Cardiac transplant recipients


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01686191

Contact: Christina L Aquilante, Pharm.D. 303-724-6126

United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Christina L Aquilante, Pharm.D.    303-724-6126   
Principal Investigator: Christina L Aquilante, Pharm.D.         
Sub-Investigator: JoAnn Lindenfeld, M.D.         
Sub-Investigator: Robert L Page, Pharm.D.         
Sponsors and Collaborators
University of Colorado, Denver
National Jewish Health
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver Identifier: NCT01686191     History of Changes
Other Study ID Numbers: 12-0869
12GRNT12040211 ( Other Grant/Funding Number: American Heart Association )
Study First Received: September 12, 2012
Last Updated: December 14, 2016

Keywords provided by University of Colorado, Denver:
heart transplantation
chronic renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017