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Genetic Predictors of Renal Dysfunction Following Heart Transplantation

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ClinicalTrials.gov Identifier: NCT01686191
Recruitment Status : Active, not recruiting
First Posted : September 17, 2012
Last Update Posted : October 31, 2017
Sponsor:
Collaborator:
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

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

U.S. FDA Resources

Group/Cohort
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

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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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT01686191


Locations
United States, Colorado
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
National Jewish Health
Investigators
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01686191     History of Changes
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: October 31, 2017
Last Verified: October 2017

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

Additional relevant MeSH terms:
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action