Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
NCT ID: NCT03442647
Last Updated: 2018-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2018-06-01
2019-08-30
Brief Summary
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The degree of renal reserve capacity becomes particularly important when the number of functioning nephrons is significantly reduced either due to surgical removal of one kidney as in living kidney donation or in tumor nephrectomy or due to progressive injury as in autosomal dominant polycystic kidney disease (ADPKD). A reduced functional reserve likely reflects an impaired adaptive capacity and increased risk of accelerated loss of function in the remaining single kidney or in kidneys exposed to a disease. Despite the importance of accurately measuring baseline and reserve capacity renal function, due to the time- and laborintensive procedure, in clinical routine this testing is rarely done.
Investigators aim to measure renal functional reserve (RFR) and loss of function in patients undergoing nephrectomy (living kidney donors and renal tumor patients) as well as in patients with ADPKD.
The results should provide evidence whether renal functional reserve indeed predicts adaptive capacity and functional loss after removal of a healthy kidney (living donors), of a tumor kidney (cancer patients) or in progressive kidney disorders (ADPKD patients).
Investigators are confident that the proposed project will enhance the understanding of progressive kidney disease and with this improve donor safety, planning of tumor nephrectomy, and prediction of renal functional loss as well as provide a strong argument that dynamic renal function testing, i.e. accurate measurement of baseline and reserve capacity, is necessary in certain disease entities.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
DIAGNOSTIC
NONE
Study Groups
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Living donors
sinistrin clearance dynamic measurement
sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load
ADPKD patients
sinistrin clearance dynamic measurement
sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load
Patients with primary renal tumor
sinistrin clearance dynamic measurement
sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load
Interventions
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sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load
Eligibility Criteria
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Inclusion Criteria
* Patients with diagnosed ADPKD
* Patients with primary kidney tumor requiring nephrectomy
* Female and male patients over 18 years of age
Exclusion Criteria
* Kidney metastases of a tumor of other origin
* Renal failure that requires dialysis
* Pregnant patient
* Incomplete medical records
* Patients with diabetes mellitus
* Patients who cannot tolerate iv fluids
* Hypersensitivity to the active substance (sinistrin) or to any of the excipients
18 Years
ALL
No
Sponsors
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Thomas Mueller
OTHER
Responsible Party
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Thomas Mueller
Prof. Dr.
Principal Investigators
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Thomas F Mueller, Prof.
Role: PRINCIPAL_INVESTIGATOR
University of Zurich
Locations
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University Hospital Zurich
Zurich, , Switzerland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2017-01839
Identifier Type: -
Identifier Source: org_study_id
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