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Genetic Predictors of Renal Dysfunction Following Heart Transplantation

This study is currently recruiting participants.
Verified April 2013 by University of Colorado, Denver
Sponsor:
Collaborator:
National Jewish Health
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01686191
First received: September 12, 2012
Last updated: April 12, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Chronic renal dysfunction [ Time Frame: year 2 post-transplant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Buccal cell and blood sample for genomic DNA


Estimated Enrollment: 195
Study Start Date: August 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Cardiac transplant recipients

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01686191

Contacts
Contact: Christina L Aquilante, Pharm.D. 303-724-6126 christina.aquilante@ucdenver.edu

Locations
United States, Colorado
University of Colorado Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Christina L Aquilante, Pharm.D.     303-724-6126     christina.aquilante@ucdenver.edu    
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
Investigators
Principal Investigator: Christina L Aquilante, Pharm.D. University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01686191     History of Changes
Other Study ID Numbers: 12-0869, 12GRNT12040211
Study First Received: September 12, 2012
Last Updated: April 12, 2013
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013