Heart TransplantationNCT01686191
Genetic Predictors of Renal Dysfunction Following Heart Transplantation
An observational study of Heart Transplantation and Chronic Renal Insufficiency, run by University of Colorado, Denver at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Heart Transplantation, Chronic Renal Insufficiency
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cardiac transplant clinic
Who may be able to join
- 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
Who cannot join
- combined organ transplant
- decisionally impaired
- unable to read or speak English
- unable or unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation
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
- Heart Transplantation, Chronic Renal Insufficiency
- Keywords
- heart transplantation, chronic renal insufficiency, pharmacogenomics, cyclosporine, tacrolimus
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac transplant recipients | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chronic renal dysfunction
Measured: year 2 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2012 (estimated)
- Study startAug 2012
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantationStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- National Jewish Health
- Responsible party
- Sponsor
- Investigators
- Christina L Aquilante, Pharm.D., Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01686191
- Sponsor's protocol ID
- 12-0869
- Other IDs
- 12GRNT12040211, UL1TR002535, TL1TR002533
- Status last verified
- May 2023
- First submitted
- 12 Sep 2012
- Last updated
- 10 May 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenomics of Calcineurin Inhibitor Nephrotoxicity in Cardiac Transplantation
- ClinicalTrials.gov ID
- NCT01686191
- Acronym / sponsor ID
- 12-0869
- Conditions
- Heart Transplantation, Chronic Renal Insufficiency
- Keywords
- heart transplantation, chronic renal insufficiency, pharmacogenomics, cyclosporine, tacrolimus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- National Jewish Health
- Study start
- Aug 2012 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 17 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac transplant recipients | – | – |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cardiac transplant clinic
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- combined organ transplant
- decisionally impaired
- unable to read or speak English
- unable or unwilling to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Chronic renal dysfunction
Time frame: year 2 post-transplant
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina L Aquilante, Pharm.D. principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Transplantation and Chronic Renal Insufficiency, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chronic renal dysfunction (time frame: year 2 post-transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2023.