DeathTxL-IRINCT03272854
TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study
An observational study of Death and Graft Failure, run by University Medical Center Groningen.
Trial summary
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Death, Graft Failure, Death, Cardiac
- How many people
- 606 participants
- Where
- No sites listed yet
- Study dates
- Aug 2001to Aug 2031
- How long will I take part?
- 30 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Stable outpatient renal transplant recipients more than 1 year after transplantation,
Who may be able to join
- More than one year after renal transplantation
- History of renal transplantation
Who cannot join
- Signs of active infection
- Signs of active cardiac decompensation
- Active malignancy other than skin cancer
- Prognosis < 1 year
About this study
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. This study is a biobank and cohort study which investigates this hypothesis.
Read the detailed description
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. To investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. At the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. Beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (NODAT).
- Conditions
- Death, Graft Failure, Death, Cardiac, Diabetes
- Being tested
- No intervention performed, the study is observational
- Medical subject headings
- Death, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention performed, the study is observationalOther
| Study group | Role | What they receive |
|---|---|---|
| Renal Transplant Recipients | A cohort or renal transplant recipients, all more than 1 year after transplantation at inclusion Receives: Other: No intervention performed, the study is observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-Cause Mortality
All-Cause Mortality
Measured: 30 years
Graft Failure
Death-Censored Graft Failure
Measured: 30 years
Secondary outcomes (3)
New Onset Diabetes After Transplantation
NODAT
Measured: 30 years
Cardiovascular Mortality
Cause-Specific Mortality
Measured: 30 years
Non-Cardiovascular Mortality
Cause-Specific Mortality
Measured: 30 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2017
- Study startAug 2001
- Primary completionJul 2003
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (48)Papers the sponsor has linked to this study.
- Other trials for DeathStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe 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
- Prospective
- Enrolment
- 606 participants (actual)
- Target duration
- 30 Years
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stephan J.L. Bakker, University Medical Center Groningen
- Investigators
- Stephan JL Bakker, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03272854
- Sponsor's protocol ID
- METc2001/039
- Acronym
- TxL-IRI
- Status last verified
- Sep 2017
- First submitted
- 2 Sep 2017
- Last updated
- 6 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data can be shared with other researchers. The researchers will then receive an anonymized dataset. The PI of the study will be co-author on papers that come out of the analyses.
Publications
de Vries AP, Bakker SJ, van Son WJ, van der Heide JJ, Ploeg RJ, The HT, de Jong PE, Gans RO. Metabolic syndrome is associated with impaired long-term renal allograft function; not all component criteria contribute equally. Am J Transplant. 2004 Oct;4(10):1675-83. doi: 10.1111/j.1600-6143.2004.00558.x.
PubMed 15367224van Ree RM, de Vries AP, Oterdoom LH, The TH, Gansevoort RT, Homan van der Heide JJ, van Son WJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Abdominal obesity and smoking are important determinants of C-reactive protein in renal transplant recipients. Nephrol Dial Transplant. 2005 Nov;20(11):2524-31. doi: 10.1093/ndt/gfi052. Epub 2005 Aug 22.
PubMed 16115856Oterdoom LH, de Vries AP, van Son WJ, van der Heide JJ, Ploeg RJ, Gansevoort RT, de Jong PE, Gans RO, Bakker SJ. Validation of insulin resistance indexes in a stable renal transplant population. Diabetes Care. 2005 Oct;28(10):2424-9. doi: 10.2337/diacare.28.10.2424.
PubMed 16186274Hartog JW, de Vries AP, Bakker SJ, Graaff R, van Son WJ, van der Heide JJ, Gans RO, Wolffenbuttel BH, de Jong PE, Smit AJ. Risk factors for chronic transplant dysfunction and cardiovascular disease are related to accumulation of advanced glycation end-products in renal transplant recipients. Nephrol Dial Transplant. 2006 Aug;21(8):2263-9. doi: 10.1093/ndt/gfl132. Epub 2006 Apr 5.
PubMed 16597636van Ree RM, Oterdoom LH, de Vries AP, Gansevoort RT, van der Heide JJ, van Son WJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Elevated levels of C-reactive protein independently predict accelerated deterioration of graft function in renal transplant recipients. Nephrol Dial Transplant. 2007 Jan;22(1):246-53. doi: 10.1093/ndt/gfl511. Epub 2006 Sep 23.
PubMed 16998222Oterdoom LH, de Vries AP, Gansevoort RT, van Son WJ, van der Heide JJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Determinants of insulin resistance in renal transplant recipients. Transplantation. 2007 Jan 15;83(1):29-35. doi: 10.1097/01.tp.0000245844.27683.48.
PubMed 17220787Oterdoom LH, de Vries AP, Gansevoort RT, de Jong PE, Gans RO, Bakker SJ. Fasting insulin modifies the relation between age and renal function. Nephrol Dial Transplant. 2007 Jun;22(6):1587-92. doi: 10.1093/ndt/gfm037. Epub 2007 Feb 21.
PubMed 17314207Gross S, van Ree RM, Oterdoom LH, de Vries AP, van Son WJ, de Jong PE, Navis GJ, Zuurman MW, Bierhaus A, Gans RO, Bakker SJ. Low levels of sRAGE are associated with increased risk for mortality in renal transplant recipients. Transplantation. 2007 Sep 15;84(5):659-63. doi: 10.1097/01.tp.0000280556.16275.2a.
PubMed 17876282van Timmeren MM, Vaidya VS, van Ree RM, Oterdoom LH, de Vries AP, Gans RO, van Goor H, Stegeman CA, Bonventre JV, Bakker SJ. High urinary excretion of kidney injury molecule-1 is an independent predictor of graft loss in renal transplant recipients. Transplantation. 2007 Dec 27;84(12):1625-30. doi: 10.1097/01.tp.0000295982.78039.ef.
PubMed 18165774Lijfering WM, de Vries AP, Veeger NJ, van Son WJ, Bakker SJ, van der Meer J. Possible contribution of cytomegalovirus infection to the high risk of (recurrent) venous thrombosis after renal transplantation. Thromb Haemost. 2008 Jan;99(1):127-32. doi: 10.1160/TH07-05-0340.
PubMed 18217144Oterdoom LH, van Ree RM, de Vries AP, Gansevoort RT, Schouten JP, van Son WJ, Homan van der Heide JJ, Navis G, de Jong PE, Gans RO, Bakker SJ. Urinary creatinine excretion reflecting muscle mass is a predictor of mortality and graft loss in renal transplant recipients. Transplantation. 2008 Aug 15;86(3):391-8. doi: 10.1097/TP.0b013e3181788aea.
PubMed 18698241van Ree RM, Oterdoom LH, de Vries AP, Homan van der Heide JJ, van Son WJ, Navis G, Gans RO, Bakker SJ. Circulating markers of endothelial dysfunction interact with proteinuria in predicting mortality in renal transplant recipients. Transplantation. 2008 Dec 27;86(12):1713-9. doi: 10.1097/TP.0b013e3181903d25.
PubMed 19104410Hartog JW, Gross S, Oterdoom LH, van Ree RM, de Vries AP, Smit AJ, Schouten JP, Nawroth PP, Gans RO, van Son WJ, Bierhaus A, Bakker SJ. Skin-autofluorescence is an independent predictor of graft loss in renal transplant recipients. Transplantation. 2009 Apr 15;87(7):1069-77. doi: 10.1097/TP.0b013e31819d3173.
PubMed 19352130Oterdoom LH, de Vries AP, van Ree RM, Gansevoort RT, van Son WJ, van der Heide JJ, Navis G, de Jong PE, Gans RO, Bakker SJ. N-terminal pro-B-type natriuretic peptide and mortality in renal transplant recipients versus the general population. Transplantation. 2009 May 27;87(10):1562-70. doi: 10.1097/TP.0b013e3181a4bb80.
PubMed 19461495van Ree RM, de Vries AP, Oterdoom LH, Seelen MA, Gansevoort RT, Schouten JP, Struck J, Navis G, Gans RO, van der Heide JJ, van Son WJ, Bakker SJ. Plasma procalcitonin is an independent predictor of graft failure late after renal transplantation. Transplantation. 2009 Jul 27;88(2):279-87. doi: 10.1097/TP.0b013e3181ac9ea0.
PubMed 19623026
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TransplantLines Insulin Resistance and Inflammation Biobank and Cohort Study
- ClinicalTrials.gov ID
- NCT03272854
- Acronym / sponsor ID
- TxL-IRI / METc2001/039
- Conditions
- Death, Graft Failure, Death, Cardiac, Diabetes
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 606 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Aug 2001 (actual)
- Primary completion
- Jul 2003 (actual)
- Study completion
- Aug 2031 (estimated)
- First posted
- 6 Sep 2017 (actual)
- 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.
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. This study is a biobank and cohort study which investigates this hypothesis.
Detailed description
Short-term (1-year) results of renal transplantation are now excellent (over 95%). Long-term (10-year and longer) results are, however, still disappointing. Where most research has focused on immunosuppression and infections, the investigators hypothesize that in renal transplant recipient, amongst others overweight, obesity, chronic use of immunosuppressive drugs and impaired renal function contribute to insulin resistance and chronic low-grade inflammation, which pose the renal transplant recipients at increased risk for cardiovascular disease, decline of function of the transplanted kidney and other complications, including post-transplant diabetes. To investigate this hypothesis we have detailedly phenotyped 606 renal transplant recipients who at the time of inclusion all were one year or more after transplantation, therewith providing a representation of stable outpatient renal trannsplant recipients late after renal transplantation. At the time of these baseline measurements, we also created a biobank with plasma, serum and aliquots of 24h urine collections. Beyond baseline, we have a regular update on adverse events, including all-cause mortality, cause-specific mortality, graft failure and development of new-onset diabetes after transplantation (NODAT).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Renal Transplant Recipients | – | Other: No intervention performed, the study is observationalA cohort or renal transplant recipients, all more than 1 year after transplantation at inclusion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Stable outpatient renal transplant recipients more than 1 year after transplantation,
Key inclusion criteria (2 listed)
- More than one year after renal transplantation
- History of renal transplantation
Key exclusion criteria (4 listed)
- Signs of active infection
- Signs of active cardiac decompensation
- Active malignancy other than skin cancer
- Prognosis < 1 year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No intervention performed, the study is observational | Other | Renal Transplant Recipients |
Primary outcome
All-Cause Mortality
Time frame: 30 years
All-Cause Mortality
Graft Failure
Time frame: 30 years
Death-Censored Graft Failure
3 secondary outcomes
New Onset Diabetes After Transplantation
Time frame: 30 years
Cardiovascular Mortality
Time frame: 30 years
Non-Cardiovascular Mortality
Time frame: 30 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2017.
- Results publication: PubMed 15367224de Vries AP, Bakker SJ, van Son WJ, van der Heide JJ, Ploeg RJ, The HT, de Jong PE, Gans RO. Metabolic syndrome is associated with impaired long-term renal allograft function; not all component criteria contribute equally. Am J Transplant. 2004 Oct;4(10):1675-83. doi: 10.1111/j.1600-6143.2004.00558.x.
- Results publication: PubMed 16115856van Ree RM, de Vries AP, Oterdoom LH, The TH, Gansevoort RT, Homan van der Heide JJ, van Son WJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Abdominal obesity and smoking are important determinants of C-reactive protein in renal transplant recipients. Nephrol Dial Transplant. 2005 Nov;20(11):2524-31. doi: 10.1093/ndt/gfi052. Epub 2005 Aug 22.
- Results publication: PubMed 16186274Oterdoom LH, de Vries AP, van Son WJ, van der Heide JJ, Ploeg RJ, Gansevoort RT, de Jong PE, Gans RO, Bakker SJ. Validation of insulin resistance indexes in a stable renal transplant population. Diabetes Care. 2005 Oct;28(10):2424-9. doi: 10.2337/diacare.28.10.2424.
- Results publication: PubMed 16597636Hartog JW, de Vries AP, Bakker SJ, Graaff R, van Son WJ, van der Heide JJ, Gans RO, Wolffenbuttel BH, de Jong PE, Smit AJ. Risk factors for chronic transplant dysfunction and cardiovascular disease are related to accumulation of advanced glycation end-products in renal transplant recipients. Nephrol Dial Transplant. 2006 Aug;21(8):2263-9. doi: 10.1093/ndt/gfl132. Epub 2006 Apr 5.
- Results publication: PubMed 16998222van Ree RM, Oterdoom LH, de Vries AP, Gansevoort RT, van der Heide JJ, van Son WJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Elevated levels of C-reactive protein independently predict accelerated deterioration of graft function in renal transplant recipients. Nephrol Dial Transplant. 2007 Jan;22(1):246-53. doi: 10.1093/ndt/gfl511. Epub 2006 Sep 23.
- Results publication: PubMed 17220787Oterdoom LH, de Vries AP, Gansevoort RT, van Son WJ, van der Heide JJ, Ploeg RJ, de Jong PE, Gans RO, Bakker SJ. Determinants of insulin resistance in renal transplant recipients. Transplantation. 2007 Jan 15;83(1):29-35. doi: 10.1097/01.tp.0000245844.27683.48.
- Results publication: PubMed 17314207Oterdoom LH, de Vries AP, Gansevoort RT, de Jong PE, Gans RO, Bakker SJ. Fasting insulin modifies the relation between age and renal function. Nephrol Dial Transplant. 2007 Jun;22(6):1587-92. doi: 10.1093/ndt/gfm037. Epub 2007 Feb 21.
- Results publication: PubMed 17876282Gross S, van Ree RM, Oterdoom LH, de Vries AP, van Son WJ, de Jong PE, Navis GJ, Zuurman MW, Bierhaus A, Gans RO, Bakker SJ. Low levels of sRAGE are associated with increased risk for mortality in renal transplant recipients. Transplantation. 2007 Sep 15;84(5):659-63. doi: 10.1097/01.tp.0000280556.16275.2a.
- Results publication: PubMed 18165774van Timmeren MM, Vaidya VS, van Ree RM, Oterdoom LH, de Vries AP, Gans RO, van Goor H, Stegeman CA, Bonventre JV, Bakker SJ. High urinary excretion of kidney injury molecule-1 is an independent predictor of graft loss in renal transplant recipients. Transplantation. 2007 Dec 27;84(12):1625-30. doi: 10.1097/01.tp.0000295982.78039.ef.
- Results publication: PubMed 18217144Lijfering WM, de Vries AP, Veeger NJ, van Son WJ, Bakker SJ, van der Meer J. Possible contribution of cytomegalovirus infection to the high risk of (recurrent) venous thrombosis after renal transplantation. Thromb Haemost. 2008 Jan;99(1):127-32. doi: 10.1160/TH07-05-0340.
- Results publication: PubMed 18698241Oterdoom LH, van Ree RM, de Vries AP, Gansevoort RT, Schouten JP, van Son WJ, Homan van der Heide JJ, Navis G, de Jong PE, Gans RO, Bakker SJ. Urinary creatinine excretion reflecting muscle mass is a predictor of mortality and graft loss in renal transplant recipients. Transplantation. 2008 Aug 15;86(3):391-8. doi: 10.1097/TP.0b013e3181788aea.
- Results publication: PubMed 19104410van Ree RM, Oterdoom LH, de Vries AP, Homan van der Heide JJ, van Son WJ, Navis G, Gans RO, Bakker SJ. Circulating markers of endothelial dysfunction interact with proteinuria in predicting mortality in renal transplant recipients. Transplantation. 2008 Dec 27;86(12):1713-9. doi: 10.1097/TP.0b013e3181903d25.
- Individual participant dataSharing planned: Undecided. The data can be shared with other researchers. The researchers will then receive an anonymized dataset. The PI of the study will be co-author on papers that come out of the analyses.
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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.
Stephan JL Bakker, MD, PhD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
An observational study of Death and Graft Failure, run by University Medical Center Groningen.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 6 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
All-Cause Mortality (time frame: 30 years). The study lists 2 primary outcomes in all. 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 NCT03272854, which also lists 48 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 6 Sep 2017.