Genetic Predictors of Renal Dysfunction Following Heart Transplantation

NCT01686191 | Unknown

• 4 other identifiers: 12-086912GRNT12040211UL1TR002535TL1TR002533
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Renal Insufficiency; Heart Transplantation

Keywords

heart transplantation; chronic renal insufficiency; pharmacogenomics; cyclosporine; tacrolimus

Outcome Measures

Primary Outcomes (1)

• Chronic renal dysfunction

  year 2 post-transplant

Study Arms (1)

Cardiac transplant recipients

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cardiac transplant clinic

You may qualify if:

• cardiac-only transplant
• years of age or older at the time of cardiac transplant
• year or more post-cardiac transplant
• treatment with cyclosporine or tacrolimus following transplant

You may not qualify if:

• combined organ transplant
• decisionally impaired
• unable to read or speak English
• unable or unwilling to provide written informed consent

Sponsors & Collaborators

• University of Colorado, Denver: lead
• National Jewish Health: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Buccal cell and blood sample for genomic DNA

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Christina L Aquilante, Pharm.D.

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 17, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 10, 2023

Record last verified: 2023-05

Locations

US (1)