Kidney TransplantDeKAFNCT00270712
A Study of Factors That Affect Long-Term Kidney Transplant Function
An observational study of Kidney Transplant, run by University of Minnesota at 7 sites in 2 countries.
Trial summary
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Transplant
- How many people
- 3,175 participants
- Where
- 7 sitesin 2 countries
- Study dates
- Oct 2005to 31 Dec 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Kidney transplant recipients
Who may be able to join
- Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Received a kidney transplant before 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
- The creatinine level on or before 01-01-2006 must be 2 mg/dl or less OR the patient must have developed new onset proteinuria, defined as having a protein/creatinine ratio of 0.4 or more
Who cannot join
None listed.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States5 sites
University of Alabama - Division of Nephrology
Birmingham, Alabama, 35294
University of Iowa - Nephrology Division
Iowa City, Iowa, 52242
Hennepin County Medical Center - Division of Nephrology
Minneapolis, Minnesota, 55415
University of Minnesota Dept of Surgery - Transplantation Division
Minneapolis, Minnesota, 55455
Mayo Clinic - Division of Nephrology
Rochester, Minnesota, 55905
Canada2 sites
University of Alberta - Division of Nephrology & Immunology
Edmonton, Alberta, T6G 2S2
Health Sciences Center - Section of Nephrology
Winnipeg, Manitoba, R3A 1R9
About this study
Official title: Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.
Read the detailed description
Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic kidney graft dysfunction is likely to be caused by certain definable factors. Such factors may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes and which specific factors are most responsible for kidney graft dysfunction may help in designing future interventional trials for kidney transplant patients. The purpose of this study is to determine whether clinical, laboratory, and histologic studies at the time of initial graft dysfunction will clarify the processes and factors that lead to deterioration and loss of a kidney graft. This is an observational study that will enroll participants who have recently received kidney transplants (prospective cohort) and participants who have had kidney transplants for a longer period of time and are now experiencing kidney graft dysfunction (retrospective cohort).
The duration of this trial may differ between participants, depending on when deterioration of kidney graft function occurs. Participants will be followed until graft loss or death. There are no exclusive study visits associated with this study. Study data are gathered from routine laboratory follow-up tests completed at the participant's local medical center and from information obtained at the time of kidney biopsy. Participants may need to undergo a kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo urine and blood collection.
- Conditions
- Kidney Transplant
- Keywords
- kidney, transplant, dysfunction, chronic, deterioration, loss of function
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
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 |
|---|---|---|
| Retrospective Cohort | 537 transplant recipient records used retrospectively | |
| Prospective Cohort | 3137 transplant recipients enrolled prospectively |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kidney transplant failure
Measured: throughout study (for prospective cohort)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2005 (estimated)
- Study startOct 2005
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 3,175 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Astellas Pharma Inc, Bristol-Myers Squibb, Novartis, Pfizer, Sanofi
- Responsible party
- Sponsor
- Investigators
- Arthur J. Matas, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00270712
- Sponsor's protocol ID
- 0407M62262
- Acronym
- DeKAF
- Status last verified
- Oct 2019
- First submitted
- 27 Dec 2005
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Hariharan S, Kasiske B, Matas A, Cohen A, Harmon W, Rabb H. Surrogate markers for long-term renal allograft survival. Am J Transplant. 2004 Jul;4(7):1179-83. doi: 10.1111/j.1600-6143.2004.00484.x.
PubMed 15196079Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. doi: 10.1111/j.1600-6143.2005.00853.x.
PubMed 15888048Matas AJ, Helgeson E, Fieberg A, Leduc R, Gaston RS, Kasiske BL, Rush D, Hunsicker L, Cosio F, Grande JP, Cecka JM, Connett J, Mannon RB. Risk Prediction for Delayed Allograft Function: Analysis of the Deterioration of Kidney Allograft Function (DeKAF) Study Data. Transplantation. 2022 Feb 1;106(2):358-368. doi: 10.1097/TP.0000000000003718.
PubMed 33675321Grande JP, Helgeson ES, Matas AJ. Correlation of Glomerular Size With Donor-Recipient Factors and With Response to Injury. Transplantation. 2021 Nov 1;105(11):2451-2460. doi: 10.1097/TP.0000000000003570.
PubMed 33273317Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.
PubMed 30801535Seibert SR, Schladt DP, Wu B, Guan W, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Tacrolimus trough and dose intra-patient variability and CYP3A5 genotype: Effects on acute rejection and graft failure in European American and African American kidney transplant recipients. Clin Transplant. 2018 Dec;32(12):e13424. doi: 10.1111/ctr.13424. Epub 2018 Oct 31.
PubMed 30318646
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Long-term Deterioration of Kidney Allograft Function (DeKAF)
- ClinicalTrials.gov ID
- NCT00270712
- Acronym / sponsor ID
- DeKAF / 0407M62262
- Conditions
- Kidney Transplant
- Keywords
- kidney, transplant, dysfunction, chronic, deterioration, loss of function
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,175 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Astellas Pharma Inc, Bristol-Myers Squibb, Novartis, Pfizer, Sanofi
- Study start
- Oct 2005
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 28 Dec 2005 (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.
The causes of deterioration of transplanted kidney function are poorly understood. The purpose of this study is to determine the disease processes that cause transplanted kidney dysfunction and loss in patients who received a kidney either recently or over a year prior to entering this study. This study will also identify specific characteristics in kidney transplant recipients that predict whether a kidney transplant will be successful.
Detailed description
Over time, chronic kidney graft dysfunction progressively threatens the long-term survival of a kidney graft. The disease processes behind graft dysfunction are unclear. However, chronic kidney graft dysfunction is likely to be caused by certain definable factors. Such factors may include collagens III and IV, transforming growth factor (TGF)-beta, T and B cell surface markers, cell cycle proteins, fibronectin, and laminin. Determining what disease processes and which specific factors are most responsible for kidney graft dysfunction may help in designing future interventional trials for kidney transplant patients. The purpose of this study is to determine whether clinical, laboratory, and histologic studies at the time of initial graft dysfunction will clarify the processes and factors that lead to deterioration and loss of a kidney graft. This is an observational study that will enroll participants who have recently received kidney transplants (prospective cohort) and participants who have had kidney transplants for a longer period of time and are now experiencing kidney graft dysfunction (retrospective cohort).
The duration of this trial may differ between participants, depending on when deterioration of kidney graft function occurs. Participants will be followed until graft loss or death. There are no exclusive study visits associated with this study. Study data are gathered from routine laboratory follow-up tests completed at the participant's local medical center and from information obtained at the time of kidney biopsy. Participants may need to undergo a kidney biopsy as clinically indicated. At the time of biopsy, participants will also undergo urine and blood collection.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Retrospective Cohort | – | –537 transplant recipient records used retrospectively |
| Prospective Cohort | – | –3137 transplant recipients enrolled prospectively |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Kidney transplant recipients
Key inclusion criteria (6 listed)
- Received a kidney transplant within 10 days prior to study entry, on or after 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Received a kidney transplant before 10-01-2005
- Recipient of kidney or simultaneous kidney/pancreas with no additional transplant at the time of the kidney transplant
- Undergoes a clinically indicated kidney biopsy due to new onset deterioration of function, defined as having an increase in serum creatinine
Key exclusion criteria (0 listed)
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
Kidney transplant failure
Time frame: throughout study (for prospective cohort)
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 1 Nov 2019.
- Background: PubMed 15196079Hariharan S, Kasiske B, Matas A, Cohen A, Harmon W, Rabb H. Surrogate markers for long-term renal allograft survival. Am J Transplant. 2004 Jul;4(7):1179-83. doi: 10.1111/j.1600-6143.2004.00484.x.
- Background: PubMed 15888048Kasiske BL, Gaston RS, Gourishankar S, Halloran PF, Matas AJ, Jeffery J, Rush D. Long-term deterioration of kidney allograft function. Am J Transplant. 2005 Jun;5(6):1405-14. doi: 10.1111/j.1600-6143.2005.00853.x.
- Derived from this study: PubMed 33675321Matas AJ, Helgeson E, Fieberg A, Leduc R, Gaston RS, Kasiske BL, Rush D, Hunsicker L, Cosio F, Grande JP, Cecka JM, Connett J, Mannon RB. Risk Prediction for Delayed Allograft Function: Analysis of the Deterioration of Kidney Allograft Function (DeKAF) Study Data. Transplantation. 2022 Feb 1;106(2):358-368. doi: 10.1097/TP.0000000000003718.
- Derived from this study: PubMed 33273317Grande JP, Helgeson ES, Matas AJ. Correlation of Glomerular Size With Donor-Recipient Factors and With Response to Injury. Transplantation. 2021 Nov 1;105(11):2451-2460. doi: 10.1097/TP.0000000000003570.
- Derived from this study: PubMed 30801535Oetting WS, Schladt DP, Dorr CR, Wu B, Guan W, Remmel RP, Ikle D, Mannon RB, Matas AJ, Israni AK, Jacobson PA; DeKAF Genomics and GEN03 Investigators. Analysis of 75 Candidate SNPs Associated With Acute Rejection in Kidney Transplant Recipients: Validation of rs2910164 in MicroRNA MIR146A. Transplantation. 2019 Aug;103(8):1591-1602. doi: 10.1097/TP.0000000000002659.
- Derived from this study: PubMed 30318646Seibert SR, Schladt DP, Wu B, Guan W, Dorr C, Remmel RP, Matas AJ, Mannon RB, Israni AK, Oetting WS, Jacobson PA. Tacrolimus trough and dose intra-patient variability and CYP3A5 genotype: Effects on acute rejection and graft failure in European American and African American kidney transplant recipients. Clin Transplant. 2018 Dec;32(12):e13424. doi: 10.1111/ctr.13424. Epub 2018 Oct 31.
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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.
Arthur J. Matas, MD principal investigator
University of Minnesota
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant, run by University of Minnesota at 7 sites in 2 countries.
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 6 inclusion and 0 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 1 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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?
Kidney transplant failure (time frame: throughout study (for prospective cohort)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00270712, which also lists 6 linked publications.
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 1 Nov 2019.