Proteinuria and Renal Perfusion in Renal Transplant Recipients

NCT06051812 | Active Not Recruiting

• 1 other identifier: TxASL2020
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Pre-kidney Transplant; Living Donor Kidney Transplantation; Renal Perfusion; End Stage Renal Disease

Keywords

Kidney transplantation

Outcome Measures

Primary Outcomes (1)

• 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

  change from baseline perfusion of native kidneys at 2 months after renal transplantation

Secondary Outcomes (9)

• Perfusion of transplant kidney measured by ASL-MRI

  2 months after renal transplantation

• Wall to lumen ratio of retinal arterioles by SLDF measurement

  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

  change from baseline retinal capillary flow at 2 months and 12 months after renal transplantation

• Central systolic pressure assessed by Sphygmocor XCEL

  change from baseline central systolic pressure at 2 months and 12 months after renal transplantation

• Pulse pressure assessed by Sphygmocor XCEL

  change from baseline pulse pressure at 2 months and 12 months after renal transplantation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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
• Other implanted metallic devices, which are not MRI compatible
• Claustrophobia
• Any other relevant clinical contraindication of MRI examination

Sponsors & Collaborators

• University of Erlangen-Nürnberg Medical School: lead

Study Sites (1)

Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg

Erlangen, 91054, Germany

Location

Related Publications (12)

• 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.

  PMID: 10580071 BACKGROUND

• Ojo 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.

  PMID: 10620213 BACKGROUND

• Liefeldt 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.

  PMID: 21059108 BACKGROUND

• Chronic 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.

  PMID: 20483451 BACKGROUND

• Peterson 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.

  PMID: 7574193 BACKGROUND

• Barnas 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.

  PMID: 9269707 BACKGROUND

• Yildiz 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.

  PMID: 10383104 BACKGROUND

• Fernandez-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.

  PMID: 11981434 BACKGROUND

• Roodnat 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.

  PMID: 11502973 BACKGROUND

• Guliyev 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.

  PMID: 26036546 BACKGROUND

• D'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.

  PMID: 15643995 BACKGROUND

• Laplante 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.

  PMID: 1099753 BACKGROUND

Related Links

• Homepage Clinical Research Center

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: September 25, 2023
• Study Start: September 2, 2021
• Primary Completion: January 27, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 5, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)