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Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function

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ClinicalTrials.gov Identifier: NCT03442647
Recruitment Status : Recruiting
First Posted : February 22, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Thomas Mueller, University of Zurich

Brief Summary:

The number of people with kidney disease is constantly rising and renal failure represents one of the major health care burdens globally. An accurate measurement of kidney function is urgently needed to better understand and treat loss of renal function. Kidneys have an intrinsic reserve capacity to respond to a higher work load by increasing filtration in their nephrons. The number of nephrons and their reserve capacity define how well kidneys can adapt to an increased demand and disease.

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.


Condition or disease Intervention/treatment Phase
Adult Polycystic Kidney Disease Kidney Neoplasms Kidney Dysfunction Diagnostic Test: sinistrin clearance dynamic measurement Not Applicable

Detailed Description:
The measurement of RFR will be performed by dynamic testing of the changes in baseline glomerular filtration rate (GFR) induced by an oral protein load. Sinistrin (a polyfructosan with identical clearance characteristics to inulin) will be used to measure GFR.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
Estimated Study Start Date : June 1, 2018
Estimated Primary Completion Date : August 30, 2018
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Tests

Arm Intervention/treatment
Active Comparator: Living donors
sinistrin clearance dynamic measurement
Diagnostic Test: sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load

Active Comparator: ADPKD patients
sinistrin clearance dynamic measurement
Diagnostic Test: sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load

Active Comparator: Patients with primary renal tumor
sinistrin clearance dynamic measurement
Diagnostic Test: sinistrin clearance dynamic measurement
sinistrin clearance measurements will be performed before and 90 min after oral protein load




Primary Outcome Measures :
  1. RFR predicts renal functional decline [ Time Frame: up to 8 months ]
    Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Potential living kidney donor
  • Patients with diagnosed ADPKD
  • Patients with primary kidney tumor requiring nephrectomy
  • Female and male patients over 18 years of age

Exclusion Criteria:

  • Bilateral kidney tumor
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03442647


Contacts
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Contact: Thomas F Mueller, Prof. +41 44 255 33 84 thomas.mueller@usz.ch

Locations
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Switzerland
University Hospital Zurich Recruiting
Zürich, Switzerland, 8091
Contact: Thomas F Mueller, Prof.    +41 44 255 33 84    thomas.mueller@usz.ch   
Contact: Andreja Figurek, Dr. med.    +41 44 255 33 84    andreja.figurek@usz.ch   
Sponsors and Collaborators
Thomas Mueller
Investigators
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Principal Investigator: Thomas F Mueller, Prof. University of Zurich

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Responsible Party: Thomas Mueller, Prof. Dr., University of Zurich
ClinicalTrials.gov Identifier: NCT03442647     History of Changes
Other Study ID Numbers: 2017-01839
First Posted: February 22, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Kidney Neoplasms
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms