CClinicalTrials.gg
Status unknownNCT03442647Updated May 14, 2018

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

An interventional study of sinistrin clearance dynamic measurement in Adult Polycystic Kidney Disease, Kidney Neoplasms and Kidney Dysfunction, sponsored by Thomas Mueller. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-14.

Sponsored by Thomas Mueller · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Adult Polycystic Kidney Disease
  • Kidney Neoplasms
  • Kidney Dysfunction
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Active comparator
    Living donors

    sinistrin clearance dynamic measurement

    Diagnostic Test: sinistrin clearance dynamic measurement

  • Active comparator
    ADPKD patients

    sinistrin clearance dynamic measurement

    Diagnostic Test: sinistrin clearance dynamic measurement

  • Active comparator
    Patients with primary renal tumor

    sinistrin clearance dynamic measurement

    Diagnostic Test: sinistrin clearance dynamic measurement

Interventions

  • Diagnostic testsinistrin clearance dynamic measurement

    sinistrin clearance measurements will be performed before and 90 min after oral protein load

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: up to 8 months

06

Study locations

1 of 1 sites recruiting
  • University Hospital Zurich
    Zürich, 8091, Switzerland
    Recruiting
07

Registry details

Key details

Study ID
NCT03442647
Lead sponsor
Thomas Mueller
Responsible party
Thomas Mueller (Prof. Dr., University of Zurich) — Sponsor-investigator
First posted
Feb 22, 2018
Start date
Jun 1, 2018 (estimated)
Primary completion
Aug 30, 2018 (estimated)
Completion
Aug 30, 2019 (estimated)
Last update
May 14, 2018

Study contacts

Thomas F Mueller, Prof.
Contact
thomas.mueller@usz.ch
+41 44 255 33 84
Thomas F Mueller, Prof.
principal investigator · University of Zurich

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion