Kidney DiseaseNCT01143532
Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes
An observational study of Kidney Disease and Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Kidney Disease, Kidney Transplantation, Kidney Failure, Chronic
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Aug 2010to 19 Oct 2015
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.
Who may be able to join
- We will study 300 African American kidney transplant dyads.
- African descent donor and African descent recipient
- Kidney transplant performed Jan 1995 - Dec 2006.
- First kidney transplant
- Kidney only transplant (excluding transplant of any other organ at any other time).
Who cannot join
- We will exclude donors whose kidneys were used in transplants in which two organs were transplanted, e.g. pancreas and kidney, either simultaneously or at separate times. We will exclude donors whose kidneys were used in second or subsequent transplants. Rationale: dual organ transplants and serial transplants are more complicated clinical situations and renal allograft survival may be shorter and thus not comparable with other kidney transplants.
- We will exclude recipients who had HIV, hepatitis B or hepatitis C infection diagnosed either before or after the kidney transplant.
- Children
- Pregnant women will be excluded but invited to participate after delivery. The rationale is the renal function is altered during pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
- Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants.
Read more
Objectives:
- To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients.
Eligibility:
- Participants in kidney transplant where both donor and recipient were of black African descent.
- Eligible transplants include both living donor and deceased donor.
Design:
- The study will involve one visit of up to 8 hours.
- All participants will provide a detailed personal and family medical history.
- All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing.
- Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.
Read the detailed description
Genetic variation in the region of MYH9 and APOL1, located on chromosome 22, is a major contributor to the increased risk for kidney disease that characterizes African descent populations, although the specific gene, causative mutations, and the molecular and cellular mechanisms remain to be determined. We propose to study the role of MYH9 and APOL1 genetic variation, as well as other genes, in renal transplant, including the effect of donor genotype on recipient outcomes and on donor outcomes. Additional exploratory studies will address 1) whether variation in other donor genes might contribute to donor and recipient outcomes, which we may address with candidate gene studies or a genome-wide association study and 2) whether recipient genotype contributes to recipient outcomes, which we will address in similar ways.
MULTICENTER STUDY. We will identify 300 kidney transplant dyads (donor/recipient pairs), in which both individuals were of African descent and the kidney transplants were performed between 1995 and 2006. We will include 150 living donor transplants (selected on the basis of the ability to locate the surviving living donor and their willingness to participate) and 150 deceased donor transplants (selected at random, to minimize survival bias of the allograft). All subjects sign consents that are identical or similar to the NIH consent.
RECIPIENT OUTCOMES. We hypothesize that genetic variants in the kidney donor genome and secondarily in recipient genome might contribute to kidney recipient outcomes. We will obtain kidney donor genotypes using blood from surviving living donors or using transplant kidney biopsy DNA from now-deceased living donors, and we will obtain deceased donor genotypes by using transplant kidney biopsies. We will obtain recipient DNA, when available, from surviving recipients or from tissues obtained from deceased recipients. We will carry out Cox proportional hazards analysis to test the primary hypothesis, that donor MYH9 and APOL1 genotype influences allograft survival. We will also develop a multivariable model to predict last follow-up glomerular filtration rate, incorporating factors known to influence transplant outcomes and examining the effect of donor MYH9 and APOL1 genotype. In exploratory studies, we determine whether recipient genetic variants influence recipient outcomes.
DONOR OUTCOMES. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. While kidney donors do not have an increased risk of chronic kidney disease compared to the general population, they do have an increased prevalence of microalbuminuria. Furthermore, the extent of compensatory renal hypertrophy appears to differ among individuals. We wish to determine whether MYH9 and APOL1 genotype affects these outcomes, as well as the uncommon occurrence of overt kidney disease after kidney donation. CLINICAL IMPLICATIONS. We believe that that these studies will expand our knowledge of how donor genotypes influence kidney transplant outcomes for both donors and recipients.
COLLABORATIVE STUDY. In separate but related studies, we will work with various collaborators who pursuing similar question under research protocols that they have generated and for which they have local IRB approvals. We will receive from these collaborators materials for preparation of DNA, from which we will genotype APOL1 and other genes known or hypothesized to be related to donor and recipient transplant outcomes.
- Keywords
- African-Americans, MYH9, Chronic Allograft Nephropathy, Chronic Kidney Disease, Proteinuria, Natural History, Kidney Disease, Kidney Transplant, African-American
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic, Renal Insufficiency, Chronic, Proteinuria
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 |
|---|---|---|
| Kidney transplant donor of black African descent. | Kidney transplant donor of black African descent. | |
| Kidney transplant recipient of black African descent | Kidney transplant recipient of black African descent. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whether variation in other donor genes might contribute to donor and recipient outcomes
Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.
Measured: 1995-2006
Secondary outcomes (1)
Whether recipient genotype contributes to recipient outcomes.
We hypothesize that genetic variants in the kidney donor genome and secondarily in recipient genome might contribute to kidney recipient outcomes.
Measured: 1995-2006
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study start12 Aug 2010
- Primary completion19 Oct 2015
- Study completion19 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- 26 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Jeffrey B Kopp, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01143532
- Sponsor's protocol ID
- 100135
- Other IDs
- 10-DK-0135
- Status last verified
- Feb 2023
- First submitted
- 11 Jun 2010
- Last updated
- 24 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Donor Genetics and Recipient Genetics in Kidney Transplant Outcomes
- ClinicalTrials.gov ID
- NCT01143532
- Acronym / sponsor ID
- 100135
- Keywords
- African-Americans, MYH9, Chronic Allograft Nephropathy, Chronic Kidney Disease, Proteinuria, Natural History, Kidney Disease, Kidney Transplant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 12 Aug 2010 (actual)
- Primary completion
- 19 Oct 2015 (actual)
- Study completion
- 19 Oct 2015 (actual)
- First posted
- 14 Jun 2010 (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.
Background:
- Genetic variation in a particular chromosome is a major contributor to the increased risk for kidney disease that is common in people of African descent, although the specific gene, mutations, and other aspects of the variations remain to be determined. By studying the outcomes of kidney transplant in donors and recipients of African descent, researchers hope to better understand the effects of this genetic variation on the success of kidney transplants.
Objectives:
- To examine possible connections between genetic variations and kidney transplant outcomes for donors and recipients.
Eligibility:
- Participants in kidney transplant where both donor and recipient were of black African descent.
- Eligible transplants include both living donor and deceased donor.
Design:
- The study will involve one visit of up to 8 hours.
- All participants will provide a detailed personal and family medical history.
- All participants will provide blood and urine samples, including a 24-hour urine collection, to test kidney function and collect material for genetic testing.
- Donor participants will also have a magnetic resonance imaging (MRI) scan of their remaining kidney.
Detailed description
Genetic variation in the region of MYH9 and APOL1, located on chromosome 22, is a major contributor to the increased risk for kidney disease that characterizes African descent populations, although the specific gene, causative mutations, and the molecular and cellular mechanisms remain to be determined. We propose to study the role of MYH9 and APOL1 genetic variation, as well as other genes, in renal transplant, including the effect of donor genotype on recipient outcomes and on donor outcomes. Additional exploratory studies will address 1) whether variation in other donor genes might contribute to donor and recipient outcomes, which we may address with candidate gene studies or a genome-wide association study and 2) whether recipient genotype contributes to recipient outcomes, which we will address in similar ways.
MULTICENTER STUDY. We will identify 300 kidney transplant dyads (donor/recipient pairs), in which both individuals were of African descent and the kidney transplants were performed between 1995 and 2006. We will include 150 living donor transplants (selected on the basis of the ability to locate the surviving living donor and their willingness to participate) and 150 deceased donor transplants (selected at random, to minimize survival bias of the allograft). All subjects sign consents that are identical or similar to the NIH consent.
RECIPIENT OUTCOMES. We hypothesize that genetic variants in the kidney donor genome and secondarily in recipient genome might contribute to kidney recipient outcomes. We will obtain kidney donor genotypes using blood from surviving living donors or using transplant kidney biopsy DNA from now-deceased living donors, and we will obtain deceased donor genotypes by using transplant kidney biopsies. We will obtain recipient DNA, when available, from surviving recipients or from tissues obtained from deceased recipients. We will carry out Cox proportional hazards analysis to test the primary hypothesis, that donor MYH9 and APOL1 genotype influences allograft survival. We will also develop a multivariable model to predict last follow-up glomerular filtration rate, incorporating factors known to influence transplant outcomes and examining the effect of donor MYH9 and APOL1 genotype. In exploratory studies, we determine whether recipient genetic variants influence recipient outcomes.
DONOR OUTCOMES. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. While kidney donors do not have an increased risk of chronic kidney disease compared to the general population, they do have an increased prevalence of microalbuminuria. Furthermore, the extent of compensatory renal hypertrophy appears to differ among individuals. We wish to determine whether MYH9 and APOL1 genotype affects these outcomes, as well as the uncommon occurrence of overt kidney disease after kidney donation. CLINICAL IMPLICATIONS. We believe that that these studies will expand our knowledge of how donor genotypes influence kidney transplant outcomes for both donors and recipients.
COLLABORATIVE STUDY. In separate but related studies, we will work with various collaborators who pursuing similar question under research protocols that they have generated and for which they have local IRB approvals. We will receive from these collaborators materials for preparation of DNA, from which we will genotype APOL1 and other genes known or hypothesized to be related to donor and recipient transplant outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kidney transplant donor of black African descent. | – | –Kidney transplant donor of black African descent. |
| Kidney transplant recipient of black African descent | – | –Kidney transplant recipient of black African descent. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.
Key inclusion criteria (5 listed)
- We will study 300 African American kidney transplant dyads.
- African descent donor and African descent recipient
- Kidney transplant performed Jan 1995 - Dec 2006.
- First kidney transplant
- Kidney only transplant (excluding transplant of any other organ at any other time).
Key exclusion criteria (4 listed)
- We will exclude donors whose kidneys were used in transplants in which two organs were transplanted, e.g. pancreas and kidney, either simultaneously or at separate times. We will exclude donors whose kidneys were used in second or subsequent transplants. Rationale: dual organ transplants and serial transplants are more complicated clinical situations and renal allograft survival may be shorter and thus not comparable with other kidney transplants.
- We will exclude recipients who had HIV, hepatitis B or hepatitis C infection diagnosed either before or after the kidney transplant.
- Children
- Pregnant women will be excluded but invited to participate after delivery. The rationale is the renal function is altered during pregnancy
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
Whether variation in other donor genes might contribute to donor and recipient outcomes
Time frame: 1995-2006
Will identify 300 kidney transplant dyads (donor/recipient pairs), which both individuals were of African descent and the kidney transplants were performed between 1995-2006. We hypothesize that genetic variants in the kidney donor affect kidney donor outcomes. Kidney donors have an increased prevalence of microalbuminuria.
1 secondary outcome
Whether recipient genotype contributes to recipient outcomes.
Time frame: 1995-2006
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Jeffrey B Kopp, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Kidney Disease and Kidney Transplantation, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 5 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: finished, as of the sponsor's last update on 24 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Whether variation in other donor genes might contribute to donor and recipient outcomes (time frame: 1995-2006). 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 24 Feb 2023.