NCT06051812Active, not recruiting
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
Source: ClinicalTrials.gov · Last updated 5 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 25 (estimated)
- First submitted
- 10 Jul 2023
- Start date
- 2 Sept 2021
- Primary completion date
- 27 Jan 2025
- Lead sponsor
- University of Erlangen-Nürnberg Medical School
- Diseases
- Chronic kidney disease
- NCT number
- NCT06051812
What you commit to
- Study type: Observational
- Planned participants: 25
- From 2 Sept 2021 to the primary completion date, 27 Jan 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- active Drug or alcohol abuse
Other illness
- Patients in unstable conditions due to any kind of serious disease, that infers with the conduction of the trial
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to 75 years · Sex: All
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.