Trial record 5 of 53 for:    Open Studies | "heart transplantation"

Genetic Predictors of Renal Dysfunction Following Heart Transplantation

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 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: December 9, 2013
Last verified: December 2013
  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:


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
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 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: December 9, 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 August 28, 2014