Transplant;Failure,KidneyNCT01442402
APOL1 Gene Variants in African American Kidney Transplant Recipients
An observational study of Transplant;Failure,Kidney and Kidney Disease, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
Aim 1: Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans Aim 2: Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease Aim 3… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transplant;Failure,Kidney, Kidney Disease, Kidney Failure, Chronic
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2014
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: African American Renal Transplant Patients
Who may be able to join
- self-reported African American
- 18 years or older
- kidney transplant within 12 years
- Aim 2:
- self-reported African American
- 18 years or older
Show all 15Show fewer
- kidney transplant within 12 years
- recurrent or de novo glomerular disease on allograft kidney biopsy
- self-reported African American
- 18 years or older
- kidney transplant within 12 years
- end stage kidney disease due to glomerular nephritis, clinically diagnosed or by native kidney biopsy
- self-reported African American
- 18 years or older
- scheduled living kidney transplant
Who cannot join
- clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine >2)
- Aim 3:
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms
Aim 1:
Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans
Aim 2:
Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease
Aim 3:
Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.
- Medical subject headings
- Kidney Diseases, Kidney Failure, 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 |
|---|---|---|
| 2 APOL1 genotypes | African American transplant recipients with homozygous APOL1 gene variants | |
| 0 or 1 APOL1 genotypes | African American transplant recipients without homozygous APOL1 gene variants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Allograft survival
Measured: year 1, 3, 5
Secondary outcomes (1)
Allograft function as measured by serum creatinine
Measured: creatinine levels at year-1, year-3 and year-5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2011 (estimated)
- Study startApr 2014
- Primary completionApr 2014
- Study completionApr 2014
Why it stopped: Lack of funding/resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transplant;Failure,KidneyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Other
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anil K. Chandraker, MD, Brigham and Women's Hospital
- Investigators
- Anil K Chandraker, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01442402
- Sponsor's protocol ID
- 2011P000734
- Status last verified
- Jan 2021
- First submitted
- 27 Sep 2011
- Last updated
- 27 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of APOL1 Gene Variants in African American Kidney Transplant Recipients: A Study of Clinical Outcomes and Molecular Mechanisms
- ClinicalTrials.gov ID
- NCT01442402
- Acronym / sponsor ID
- 2011P000734
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Lack of funding/resources
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Sep 2011 (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.
Aim 1:
Determine if there is an association between the APOL1 risk variants and allograft survival and function in African Americans
Aim 2:
Determine if there is an association between the presence of APOL1 risk variants in an African American kidney transplant recipient and the risk of recurrent disease
Aim 3:
Investigate mechanisms of APOL1 associated kidney disease by prospectively following African American kidney transplant recipients throughout their clinical course.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 APOL1 genotypes | – | –African American transplant recipients with homozygous APOL1 gene variants |
| 0 or 1 APOL1 genotypes | – | –African American transplant recipients without homozygous APOL1 gene variants |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- African American Renal Transplant Patients
Key inclusion criteria (15 listed)
- self-reported African American
- 18 years or older
- kidney transplant within 12 years
- self-reported African American
- 18 years or older
Key exclusion criteria (2 listed)
- clinical evidence of recurrent disease (presence of proteinuria, hematuria, Creatinine >2)
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
Allograft survival
Time frame: year 1, 3, 5
1 secondary outcome
Allograft function as measured by serum creatinine
Time frame: creatinine levels at year-1, year-3 and year-5
Results and safety
The study was stopped early (reason given: Lack of funding/resources). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2021.
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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.
Anil K Chandraker, MD principal investigator
Brigham and Women's Hospital
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 Transplant;Failure,Kidney and Kidney Disease, run by Brigham and Women's Hospital 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 15 inclusion and 2 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: stopped early, as of the sponsor's last update on 27 Jan 2021. 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?
The study was stopped early (reason given: Lack of funding/resources). 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?
Allograft survival (time frame: year 1, 3, 5). 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 27 Jan 2021.