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NCT06051812Fut, nem toboroz

Proteinuria and Renal Perfusion in Renal Transplant Recipients

A Prospective, Observational, Non-interventional, Single-center Study to Analyze the Relationship Between Proteinuria and Renal Perfusion in Renal Transplant Recipients

Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. máj. 5.

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Rövid összefoglaló (regiszter, angolul)

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.

Állapot (regiszter)
Fut, nem toboroz
Vizsgálattípus
Megfigyeléses
Résztvevők száma
25 (tervezett)
Első benyújtás
2023. júl. 10.
Kezdés
2021. szept. 2.
Elsődleges befejezés
2025. jan. 27.
Fő szponzor
University of Erlangen-Nürnberg Medical School
NCT-szám
NCT06051812

Mit vállalsz

  • Vizsgálat típusa: Megfigyeléses
  • Tervezett résztvevők: 25
  • 2021. szept. 2. és az elsődleges befejezés (2025. jan. 27.) között
  • 1 helyszín, 1 országban
  • Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket

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Korábbi kezelés

  • active Drug or alcohol abuse

Más betegség

  • Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial

Egyéb

  • 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

Kiket keres a vizsgálat

  • 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

Életkor a regiszterben: 18 év – 75 év · Nem: nők és férfiak

A teljes feltétellista: ClinicalTrials.gov

Helyszínek (1)

Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.

HelyszínVárosOrszágHelyszín állapota
Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-NurembergErlangenNémetországIsmeretlen állapot

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