Pre-kidney TransplantNCT06051812
Proteinuria and Renal Perfusion in Renal Transplant Recipients
An observational study of Pre-kidney Transplant and Living Donor Kidney Transplantation, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
Trial summary
Cardiovascular disease remains one of the major cause of mortality in renal transplant recipients, with the rate of cardiac death 10-times higher than that of the general population. An independent association between post-transplant proteinuria and cardiovascular risk has been previously reported. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pre-kidney Transplant, Living Donor Kidney Transplantation, Renal Perfusion
- How many people
- 25 participants
- Where
- 1 siteGermany
- Study dates
- 2 Sep 2021to 31 Dec 2026
- 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 to 75 years
- All sexes
- Adult, Older adult
Study population: Patients will be included in the study only if they satisfy all the inclusion criteria and are not precluded from participation by any of the exclusion criteria. 25 pre-kidney transplant patients of our living donar kidney transplantation program will be included in this study.
Who may be able to join
- Age of 18 - 75 years
- Male and Female patients
- Patients evaluated and accepted for living donor kidney transplantation with residual urine output of at least 500 ml/24 hours
- Informed consent has to be given in written form
Who cannot join
- Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial
- active Drug or alcohol abuse
- Pregnant and breast-feeding patients
- Body mass index > 35 kg/m²
- Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
- Implanted pacemakers or defibrillators
Show all 9Show fewer
- Other implanted metallic devices, which are not MRI compatible
- Claustrophobia
- Any other relevant clinical contraindication of MRI examination
Trial locations and contacts
1 site in 1 country.
Germany1 site
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg
Erlangen, 91054
About this study
Official title: A Prospective, Observational, Non-interventional, Single-center Study to Analyze the Relationship Between Proteinuria and Renal Perfusion in Renal Transplant Recipients
Cardiovascular disease remains one of the major cause of mortality in renal transplant recipients, with the rate of cardiac death 10-times higher than that of the general population. An independent association between post-transplant proteinuria and cardiovascular risk has been previously reported. Diseased native kidneys with residual urine output or the transplanted kidney could be the source of proteinuria following renal transplantation. A clear differentiation of the source of proteinuria (native kidneys versus allograft) could be important for appropriate management.
Proteinuria from native kidneys falls rapidly after renal transplantation, and persistent or worsening proteinuria is usually indicative of allograft pathology. The mechanisms behind the resolution of proteinuria of native kidney origin in the early post-transplant period are not well described.
Read more
An association between vascular parameters of the macrocirculation and post-transplant proteinuria has been described. To the best of our knowledge no data is available describing a link between post-transplant proteinuria and vascular parameters of the microcirculation.
In this study our goal is to analyze in a clinical trial in patients with end stage renal disease and residual urine output the relationship between proteinuria and renal perfusion of native kidneys before and after renal transplantation. In addition the investigators analyse if pre or post-transplant proteinuria is associated vascular and circulatory changes in the retinal circulation.
Our hypothesis is that renal perfusion of native kidneys correlates with early post-transplant proteinuria. Moreover the investigators hypothesize that post-transplant proteinuria is associated with vascular remodeling processes of the microcirculation 2 and 4 to 12 months after transplantation. To prove this hypothesis the investigators aim to include 25 pre kidney transplant patients of our living donor kidney transplantation program.
Total duration of this study for each patient is 5-12 months with total 4 visits, of which all are performed at the Clinical Research Center of the Department of Nephrology and Hypertension, University of Erlangen-Nuremberg. This study is important to better understand the mechanisms behind the fall of proteinuria after renal transplantation and the association between post-transplant proteinuria and cardiovascular risk.
Read the detailed description
Renal transplantation is the treatment of choice for patients with end-stage kidney disease. Although renal transplantation is associated with reduced morbidity and mortality compared to chronic dialysis, cardiovascular disease remains one of the major cause of mortality in this population, with the rate of cardiac death 10-times higher than that of the general population. Proteinuria is not only considered as a diagnostic marker of renal disease in both native as well as the transplanted kidney, but also is widely described as an independent risk factor for cardiovascular morbidity and mortality in general population. Analogous to its impact in the general population, an independent association between post-transplant proteinuria and cardiovascular risk has been previously reported. The prevalence of proteinuria in renal transplant recipients is reported between 10% and 45%. Fernandez-Fresnedo et al. demonstrated that persistent proteinuria doubles the risk of cardiovascular disease and all-cause mortality in renal transplant recipients. Diseased native kidneys with residual urine output or the transplanted kidney could be the source of proteinuria following renal transplantation. A clear differentiation of the source of proteinuria (native kidneys versus allograft) is important for appropriate management.
Proteinuria from native kidneys falls rapidly after renal transplantation, and persistent or worsening proteinuria is usually indicative of allograft pathology. The mechanisms behind the resolution of proteinuria of native kidney origin in the early post-transplant period are not well described. CNI-induced renal vasoconstriction causing reduction in urine output from the native kidneys may be an explanation for the early resolution of native kidney proteinuria. However, the resolution of proteinuria of native kidney origin post-transplant have been reported in the pre-cyclosporine era.
An association between vascular parameters of the macrocirculation and post-transplant proteinuria has been described. High-grade post-transplant proteinuria has been found to be associated with higher pulse wave velocity, which is a marker of arterial stiffness of large arteries. Up to our knowledge no data is available describing a link between post-transplant proteinuria and vascular parameters of the microcirculation. In this study our goal is to analyze in a clinical trial in patients with end stage renal disease and residual urine output the relationship between proteinuria and renal perfusion of native kidneys before and after renal transplantation. In addition the investigators analyse if pre- or post-transplant proteinuria is associated with vascular and circulatory changes in the retinal circulation.
This study is a single-centre clinical study with 25 pre-kidney transplant patients of our living donor kidney transplantation program. This is an exploratory and non-confirmatory study, in which the investigators analyse renal perfusion of native kidneys in patients with end stage renal disease before and after kidney transplantation. Our hypothesis is that renal perfusion of native kidneys correlates with early post-transplant proteinuria. Moreover the investigators hypothesize that post-transplant proteinuria is associated with vascular remodeling processes of the microcirculation 2 and 4-12 months after transplantation.
- Conditions
- Pre-kidney Transplant, Living Donor Kidney Transplantation, Renal Perfusion, End Stage Renal Disease
- Keywords
- Kidney transplantation
- Medical subject headings
- Kidney Failure, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Perfusion of native kidneys measured by ASL-MRI
The primary objective of the study is to analyze is to measure renal perfusion of native kidneys before and after renal transplantation
Measured: change from baseline perfusion of native kidneys at 2 months after renal transplantation
Secondary outcomes (9)
Perfusion of transplant kidney measured by ASL-MRI
analyze perfusion of renal transplant
Measured: 2 months after renal transplantation
Wall to lumen ratio of retinal arterioles by SLDF measurement
analyze wall to lumen ratio of retinal arterioles before and after renal transplant
Measured: change from baseline Wall to lumen ratio of retinal arterioles at 2 months and 12 months after renal transplantation
Retinal capillary flow determined by SLDF measurement
analyze retinal capillary flow before and after renal transplant
Measured: change from baseline retinal capillary flow at 2 months and 12 months after renal transplantation
Central systolic pressure assessed by Sphygmocor XCEL
analyze central systolic pressure before and after renal transplant
Measured: change from baseline central systolic pressure at 2 months and 12 months after renal transplantation
Pulse pressure assessed by Sphygmocor XCEL
analyze pulse pressure before and after renal transplant
Measured: change from baseline pulse pressure at 2 months and 12 months after renal transplantation
Pulse wave velocity assessed by Sphygmocor XCEL
analyze pulse wave velocity before and after renal transplant
Measured: change from baseline pulse wave velocity at 2 months and 12 months after renal transplantation
estimated glomerular filtration rate assessed in our central lab
analyze estimated glomerular filtration rate before and after renal transplant
Measured: change from baseline estimated glomerular filtration rate at 2 months and 12 months after renal transplantation
Cystatin C assessed in our central lab
analyze Cystatin C before and after renal transplant
Measured: change from baseline Cystatin C at 2 months and 12 months after renal transplantation
Urinary albumin creatinine ratio assessed in our central lab
analyze Urinary albumin creatinine ratio before and after renal transplant in both spot and 24-h urine
Measured: change from baseline urinary albumine creatinine ratio at 2 months and 12 months after renal transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2023
- Study start2 Sep 2021
- Primary completion27 Jan 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Pre-kidney TransplantStudies of the same condition, open and under way.
- More trials run by University of Erlangen-Nürnberg Medical SchoolThe 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
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06051812
- Sponsor's protocol ID
- TxASL2020
- Status last verified
- Jun 2025
- First submitted
- 10 Jul 2023
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
PubMed 10580071Ojo AO, Hanson JA, Wolfe RA, Leichtman AB, Agodoa LY, Port FK. Long-term survival in renal transplant recipients with graft function. Kidney Int. 2000 Jan;57(1):307-13. doi: 10.1046/j.1523-1755.2000.00816.x.
PubMed 10620213Liefeldt L, Budde K. Risk factors for cardiovascular disease in renal transplant recipients and strategies to minimize risk. Transpl Int. 2010 Dec;23(12):1191-204. doi: 10.1111/j.1432-2277.2010.01159.x. Epub 2010 Sep 7.
PubMed 21059108Chronic Kidney Disease Prognosis Consortium; Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.
PubMed 20483451Peterson JC, Adler S, Burkart JM, Greene T, Hebert LA, Hunsicker LG, King AJ, Klahr S, Massry SG, Seifter JL. Blood pressure control, proteinuria, and the progression of renal disease. The Modification of Diet in Renal Disease Study. Ann Intern Med. 1995 Nov 15;123(10):754-62. doi: 10.7326/0003-4819-123-10-199511150-00003.
PubMed 7574193Barnas U, Schmidt A, Haas M, Kaider A, Tillawi S, Wamser P, Mayer G. Parameters associated with chronic renal transplant failure. Nephrol Dial Transplant. 1997;12 Suppl 2:82-5.
PubMed 9269707Yildiz A, Erkoc R, Sever MS, Turkmen A, Ecder ST, Turk S, Kilicarslan I, Ark E. The prognostic importance of severity and type of post-transplant proteinuria. Clin Transplant. 1999 Jun;13(3):241-4. doi: 10.1034/j.1399-0012.1999.130304.x.
PubMed 10383104Fernandez-Fresnedo G, Escallada R, Rodrigo E, De Francisco AL, Cotorruelo JG, Sanz De Castro S, Zubimendi JA, Ruiz JC, Arias M. The risk of cardiovascular disease associated with proteinuria in renal transplant patients. Transplantation. 2002 Apr 27;73(8):1345-8. doi: 10.1097/00007890-200204270-00028.
PubMed 11981434Roodnat JI, Mulder PG, Rischen-Vos J, van Riemsdijk IC, van Gelder T, Zietse R, IJzermans JN, Weimar W. Proteinuria after renal transplantation affects not only graft survival but also patient survival. Transplantation. 2001 Aug 15;72(3):438-44. doi: 10.1097/00007890-200108150-00014.
PubMed 11502973Guliyev O, Sayin B, Uyar ME, Genctoy G, Sezer S, Bal Z, Demirci BG, Haberal M. High-grade proteinuria as a cardiovascular risk factor in renal transplant recipients. Transplant Proc. 2015 May;47(4):1170-3. doi: 10.1016/j.transproceed.2014.10.062.
PubMed 26036546D'Cunha PT, Parasuraman R, Venkat KK. Rapid resolution of proteinuria of native kidney origin following live donor renal transplantation. Am J Transplant. 2005 Feb;5(2):351-5. doi: 10.1111/j.1600-6143.2004.00665.x.
PubMed 15643995Laplante L, Beaudry C, Houde M. [Early disappearance of proteinuria attributed to the original kidneys after kidney transplantation]. Union Med Can. 1975 Feb;104(2):246-8. No abstract available. French.
PubMed 1099753
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational, Non-interventional, Single-center Study to Analyze the Relationship Between Proteinuria and Renal Perfusion in Renal Transplant Recipients
- ClinicalTrials.gov ID
- NCT06051812
- Acronym / sponsor ID
- TxASL2020
- Conditions
- Pre-kidney Transplant, Living Donor Kidney Transplantation, Renal Perfusion, End Stage Renal Disease
- Keywords
- Kidney transplantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of Erlangen-Nürnberg Medical SchoolUniversity, hospital or other
- Study start
- 2 Sep 2021 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 25 Sep 2023 (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.
Cardiovascular disease remains one of the major cause of mortality in renal transplant recipients, with the rate of cardiac death 10-times higher than that of the general population. An independent association between post-transplant proteinuria and cardiovascular risk has been previously reported. Diseased native kidneys with residual urine output or the transplanted kidney could be the source of proteinuria following renal transplantation. A clear differentiation of the source of proteinuria (native kidneys versus allograft) could be important for appropriate management.
Proteinuria from native kidneys falls rapidly after renal transplantation, and persistent or worsening proteinuria is usually indicative of allograft pathology. The mechanisms behind the resolution of proteinuria of native kidney origin in the early post-transplant period are not well described.
An association between vascular parameters of the macrocirculation and post-transplant proteinuria has been described. To the best of our knowledge no data is available describing a link between post-transplant proteinuria and vascular parameters of the microcirculation.
In this study our goal is to analyze in a clinical trial in patients with end stage renal disease and residual urine output the relationship between proteinuria and renal perfusion of native kidneys before and after renal transplantation. In addition the investigators analyse if pre or post-transplant proteinuria is associated vascular and circulatory changes in the retinal circulation.
Our hypothesis is that renal perfusion of native kidneys correlates with early post-transplant proteinuria. Moreover the investigators hypothesize that post-transplant proteinuria is associated with vascular remodeling processes of the microcirculation 2 and 4 to 12 months after transplantation. To prove this hypothesis the investigators aim to include 25 pre kidney transplant patients of our living donor kidney transplantation program.
Total duration of this study for each patient is 5-12 months with total 4 visits, of which all are performed at the Clinical Research Center of the Department of Nephrology and Hypertension, University of Erlangen-Nuremberg. This study is important to better understand the mechanisms behind the fall of proteinuria after renal transplantation and the association between post-transplant proteinuria and cardiovascular risk.
Detailed description
Renal transplantation is the treatment of choice for patients with end-stage kidney disease. Although renal transplantation is associated with reduced morbidity and mortality compared to chronic dialysis, cardiovascular disease remains one of the major cause of mortality in this population, with the rate of cardiac death 10-times higher than that of the general population. Proteinuria is not only considered as a diagnostic marker of renal disease in both native as well as the transplanted kidney, but also is widely described as an independent risk factor for cardiovascular morbidity and mortality in general population. Analogous to its impact in the general population, an independent association between post-transplant proteinuria and cardiovascular risk has been previously reported. The prevalence of proteinuria in renal transplant recipients is reported between 10% and 45%. Fernandez-Fresnedo et al. demonstrated that persistent proteinuria doubles the risk of cardiovascular disease and all-cause mortality in renal transplant recipients. Diseased native kidneys with residual urine output or the transplanted kidney could be the source of proteinuria following renal transplantation. A clear differentiation of the source of proteinuria (native kidneys versus allograft) is important for appropriate management.
Proteinuria from native kidneys falls rapidly after renal transplantation, and persistent or worsening proteinuria is usually indicative of allograft pathology. The mechanisms behind the resolution of proteinuria of native kidney origin in the early post-transplant period are not well described. CNI-induced renal vasoconstriction causing reduction in urine output from the native kidneys may be an explanation for the early resolution of native kidney proteinuria. However, the resolution of proteinuria of native kidney origin post-transplant have been reported in the pre-cyclosporine era.
An association between vascular parameters of the macrocirculation and post-transplant proteinuria has been described. High-grade post-transplant proteinuria has been found to be associated with higher pulse wave velocity, which is a marker of arterial stiffness of large arteries. Up to our knowledge no data is available describing a link between post-transplant proteinuria and vascular parameters of the microcirculation. In this study our goal is to analyze in a clinical trial in patients with end stage renal disease and residual urine output the relationship between proteinuria and renal perfusion of native kidneys before and after renal transplantation. In addition the investigators analyse if pre- or post-transplant proteinuria is associated with vascular and circulatory changes in the retinal circulation.
This study is a single-centre clinical study with 25 pre-kidney transplant patients of our living donor kidney transplantation program. This is an exploratory and non-confirmatory study, in which the investigators analyse renal perfusion of native kidneys in patients with end stage renal disease before and after kidney transplantation. Our hypothesis is that renal perfusion of native kidneys correlates with early post-transplant proteinuria. Moreover the investigators hypothesize that post-transplant proteinuria is associated with vascular remodeling processes of the microcirculation 2 and 4-12 months after transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients will be included in the study only if they satisfy all the inclusion criteria and are not precluded from participation by any of the exclusion criteria. 25 pre-kidney transplant patients of our living donar kidney transplantation program will be included in this study.
Key inclusion criteria (4 listed)
- Age of 18 - 75 years
- Male and Female patients
- Patients evaluated and accepted for living donor kidney transplantation with residual urine output of at least 500 ml/24 hours
- Informed consent has to be given in written form
Key exclusion criteria (9 listed)
- Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial
- active Drug or alcohol abuse
- Pregnant and breast-feeding patients
- Body mass index > 35 kg/m²
- Subjects who do not give written consent, that pseudonymous data will be transferred in line with the duty of documentation and the duty of notification according to § 12 and § 13 GCP-V
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
Perfusion of native kidneys measured by ASL-MRI
Time frame: change from baseline perfusion of native kidneys at 2 months after renal transplantation
The primary objective of the study is to analyze is to measure renal perfusion of native kidneys before and after renal transplantation
9 secondary outcomes
Perfusion of transplant kidney measured by ASL-MRI
Time frame: 2 months after renal transplantation
Wall to lumen ratio of retinal arterioles by SLDF measurement
Time frame: change from baseline Wall to lumen ratio of retinal arterioles at 2 months and 12 months after renal transplantation
Retinal capillary flow determined by SLDF measurement
Time frame: change from baseline retinal capillary flow at 2 months and 12 months after renal transplantation
Central systolic pressure assessed by Sphygmocor XCEL
Time frame: change from baseline central systolic pressure at 2 months and 12 months after renal transplantation
Pulse pressure assessed by Sphygmocor XCEL
Time frame: change from baseline pulse pressure at 2 months and 12 months after renal transplantation
Pulse wave velocity assessed by Sphygmocor XCEL
Time frame: change from baseline pulse wave velocity at 2 months and 12 months after renal transplantation
estimated glomerular filtration rate assessed in our central lab
Time frame: change from baseline estimated glomerular filtration rate at 2 months and 12 months after renal transplantation
Cystatin C assessed in our central lab
Time frame: change from baseline Cystatin C at 2 months and 12 months after renal transplantation
Urinary albumin creatinine ratio assessed in our central lab
Time frame: change from baseline urinary albumine creatinine ratio at 2 months and 12 months after renal transplantation
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 5 May 2026.
- Background: PubMed 10580071Wolfe RA, Ashby VB, Milford EL, Ojo AO, Ettenger RE, Agodoa LY, Held PJ, Port FK. Comparison of mortality in all patients on dialysis, patients on dialysis awaiting transplantation, and recipients of a first cadaveric transplant. N Engl J Med. 1999 Dec 2;341(23):1725-30. doi: 10.1056/NEJM199912023412303.
- Background: PubMed 10620213Ojo AO, Hanson JA, Wolfe RA, Leichtman AB, Agodoa LY, Port FK. Long-term survival in renal transplant recipients with graft function. Kidney Int. 2000 Jan;57(1):307-13. doi: 10.1046/j.1523-1755.2000.00816.x.
- Background: PubMed 21059108Liefeldt L, Budde K. Risk factors for cardiovascular disease in renal transplant recipients and strategies to minimize risk. Transpl Int. 2010 Dec;23(12):1191-204. doi: 10.1111/j.1432-2277.2010.01159.x. Epub 2010 Sep 7.
- Background: PubMed 20483451Chronic Kidney Disease Prognosis Consortium; Matsushita K, van der Velde M, Astor BC, Woodward M, Levey AS, de Jong PE, Coresh J, Gansevoort RT. Association of estimated glomerular filtration rate and albuminuria with all-cause and cardiovascular mortality in general population cohorts: a collaborative meta-analysis. Lancet. 2010 Jun 12;375(9731):2073-81. doi: 10.1016/S0140-6736(10)60674-5. Epub 2010 May 17.
- Background: PubMed 7574193Peterson JC, Adler S, Burkart JM, Greene T, Hebert LA, Hunsicker LG, King AJ, Klahr S, Massry SG, Seifter JL. Blood pressure control, proteinuria, and the progression of renal disease. The Modification of Diet in Renal Disease Study. Ann Intern Med. 1995 Nov 15;123(10):754-62. doi: 10.7326/0003-4819-123-10-199511150-00003.
- Background: PubMed 9269707Barnas U, Schmidt A, Haas M, Kaider A, Tillawi S, Wamser P, Mayer G. Parameters associated with chronic renal transplant failure. Nephrol Dial Transplant. 1997;12 Suppl 2:82-5.
- Background: PubMed 10383104Yildiz A, Erkoc R, Sever MS, Turkmen A, Ecder ST, Turk S, Kilicarslan I, Ark E. The prognostic importance of severity and type of post-transplant proteinuria. Clin Transplant. 1999 Jun;13(3):241-4. doi: 10.1034/j.1399-0012.1999.130304.x.
- Background: PubMed 11981434Fernandez-Fresnedo G, Escallada R, Rodrigo E, De Francisco AL, Cotorruelo JG, Sanz De Castro S, Zubimendi JA, Ruiz JC, Arias M. The risk of cardiovascular disease associated with proteinuria in renal transplant patients. Transplantation. 2002 Apr 27;73(8):1345-8. doi: 10.1097/00007890-200204270-00028.
- Background: PubMed 11502973Roodnat JI, Mulder PG, Rischen-Vos J, van Riemsdijk IC, van Gelder T, Zietse R, IJzermans JN, Weimar W. Proteinuria after renal transplantation affects not only graft survival but also patient survival. Transplantation. 2001 Aug 15;72(3):438-44. doi: 10.1097/00007890-200108150-00014.
- Background: PubMed 26036546Guliyev O, Sayin B, Uyar ME, Genctoy G, Sezer S, Bal Z, Demirci BG, Haberal M. High-grade proteinuria as a cardiovascular risk factor in renal transplant recipients. Transplant Proc. 2015 May;47(4):1170-3. doi: 10.1016/j.transproceed.2014.10.062.
- Background: PubMed 15643995D'Cunha PT, Parasuraman R, Venkat KK. Rapid resolution of proteinuria of native kidney origin following live donor renal transplantation. Am J Transplant. 2005 Feb;5(2):351-5. doi: 10.1111/j.1600-6143.2004.00665.x.
- Background: PubMed 1099753Laplante L, Beaudry C, Houde M. [Early disappearance of proteinuria attributed to the original kidneys after kidney transplantation]. Union Med Can. 1975 Feb;104(2):246-8. No abstract available. French.
- Homepage Clinical Research CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pre-kidney Transplant and Living Donor Kidney Transplantation, run by University of Erlangen-Nürnberg Medical School at 1 site in Germany.
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 9 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 5 May 2026. 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 Germany. 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?
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?
Perfusion of native kidneys measured by ASL-MRI (time frame: change from baseline perfusion of native kidneys at 2 months after renal transplantation). 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 NCT06051812, which also lists 12 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 5 May 2026.