Genetic Predictors of Renal Dysfunction Following Heart Transplantation

NCT ID: NCT01686191

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Heart Transplantation Chronic Renal Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cardiac transplant recipients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Jewish Health

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christina L Aquilante, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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12GRNT12040211

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

UL1TR002535

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TL1TR002533

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-0869

Identifier Type: -

Identifier Source: org_study_id

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