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

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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

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.
    


Study Type

Interventional


Primary Outcome

RFR predicts renal functional decline


Condition

Adult Polycystic Kidney Disease

Intervention

sinistrin clearance dynamic measurement

Study Arms / Comparison Groups

 Living donors
Description:  sinistrin clearance dynamic measurement

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

30

Start Date

June 1, 2018

Completion Date

August 30, 2019

Primary Completion Date

August 30, 2018

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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Thomas F Mueller, Prof., +41 44 255 33 84, [email protected]

Location Countries

Switzerland

Location Countries

Switzerland

Administrative Informations


NCT ID

NCT03442647

Organization ID

2017-01839


Responsible Party

Sponsor-Investigator

Study Sponsor

Thomas Mueller


Study Sponsor

Thomas F Mueller, Prof., Principal Investigator, University of Zurich


Verification Date

May 2018