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

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.

Study Overview

• Status: Unknown
• Conditions: Kidney Neoplasms; Adult Polycystic Kidney Disease; Kidney Dysfunction
• Intervention / Treatment: Diagnostic test: sinistrin clearance dynamic measurement

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas F Mueller, Prof.; Phone Number: +41 44 255 33 84; Email: thomas.mueller@usz.ch

Study Locations

• Switzerland
  • Zürich, Switzerland, 8091
    • Recruiting
    • University Hospital Zurich
    • Contact: Thomas F Mueller, Prof.; Phone Number: +41 44 255 33 84; Email: thomas.mueller@usz.ch
    • Contact: Andreja Figurek, Dr. med.; Phone Number: +41 44 255 33 84; Email: andreja.figurek@usz.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: SEQUENTIAL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
RFR predicts renal functional decline	Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.	up to 8 months

Collaborators and Investigators

• Sponsor: Thomas Mueller
• Investigators: Principal Investigator: Thomas F Mueller, Prof., University of Zurich

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): June 1, 2018
• Primary Completion (ANTICIPATED): August 30, 2018
• Study Completion (ANTICIPATED): August 30, 2019

Study Registration Dates

• First Submitted: February 5, 2018
• First Submitted That Met QC Criteria: February 20, 2018
• First Posted (ACTUAL): February 22, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 14, 2018
• Last Update Submitted That Met QC Criteria: May 11, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Urologic Diseases; Congenital Abnormalities; Genetic Diseases, Inborn; Abnormalities, Multiple; Kidney Diseases, Cystic; Ciliopathies; Kidney Neoplasms; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
• Other Study ID Numbers: 2017-01839

Drug and device information, study documents

• 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