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

Primary Purpose

Adult Polycystic Kidney Disease, Kidney Neoplasms, Kidney Dysfunction

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
sinistrin clearance dynamic measurement
Sponsored by
Thomas Mueller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Adult Polycystic Kidney Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital ZurichRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Living donors

ADPKD patients

Patients with primary renal tumor

Arm Description

sinistrin clearance dynamic measurement

sinistrin clearance dynamic measurement

sinistrin clearance dynamic measurement

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2018
Last Updated
May 11, 2018
Sponsor
Thomas Mueller
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1. Study Identification

Unique Protocol Identification Number
NCT03442647
Brief Title
Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
Official Title
Dynamic Measurement of Renal Functional Reserve as a Predictor of Long-Term Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2018 (Anticipated)
Primary Completion Date
August 30, 2018 (Anticipated)
Study Completion Date
August 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Thomas Mueller

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adult Polycystic Kidney Disease, Kidney Neoplasms, Kidney Dysfunction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Living donors
Arm Type
Active Comparator
Arm Description
sinistrin clearance dynamic measurement
Arm Title
ADPKD patients
Arm Type
Active Comparator
Arm Description
sinistrin clearance dynamic measurement
Arm Title
Patients with primary renal tumor
Arm Type
Active Comparator
Arm Description
sinistrin clearance dynamic measurement
Intervention Type
Diagnostic Test
Intervention Name(s)
sinistrin clearance dynamic measurement
Intervention Description
sinistrin clearance measurements will be performed before and 90 min after oral protein load
Primary Outcome Measure Information:
Title
RFR predicts renal functional decline
Description
Sinistrin levels in plasma before and after oral protein load. Participants with impaired RFR are expected to have higher sinitrin levels in plasma.
Time Frame
up to 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thomas F Mueller, Prof.
Phone
+41 44 255 33 84
Email
thomas.mueller@usz.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas F Mueller, Prof.
Organizational Affiliation
University of Zurich
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Zurich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas F Mueller, Prof.
Phone
+41 44 255 33 84
Email
thomas.mueller@usz.ch
First Name & Middle Initial & Last Name & Degree
Andreja Figurek, Dr. med.
Phone
+41 44 255 33 84
Email
andreja.figurek@usz.ch

12. IPD Sharing Statement

Learn more about this trial

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

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