Trial document





This trial has been registered retrospectively.
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  DRKS00006197

Trial Description

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Title

A prospective clinical study of the influence of donor nephron mass index on graft function after kidney transplantation

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Trial Acronym

Nephron mass study

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URL of the Trial

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Brief Summary in Lay Language

This study has the aim to estimate the functioning nephron mass namely, the number of nephrons in the grafted kidney. The nephron mass is responsible for the production of the primary urine. In the context of kidney transplantations the transplanted nephron mass is an important factor influencing long-term allograft survival and kidney function, but accurate measurement is challenging. The aim of this study was to determine a nephron mass index (NMI) and its relationship to the kidney function (creatinine clearance).

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Brief Summary in Scientific Language

Transplanted nephron mass is an important factor influencing long-term allograft survival, but accurate measurement is challenging. The aim of this study was to determine a nephron mass index (NMI) and its relationship to creatinine clearance (CrCl) after transplantation.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00006197
  •   2014/06/02
  •   [---]*
  •   yes
  •   Approved
  •   72/12, Ethikkommission des Fachbereichs Humanmedizin der Johann-Wolfgang-Goethe-Universität Frankfurt am Main
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Secondary IDs

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Health Condition or Problem studied

  •   N18.4 -  Chronic kidney disease, stage 4
  •   N18.5 -  Chronic kidney disease, stage 5
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Interventions/Observational Groups

  •   1. measurment of the nephron mass of the donor organ before kidney transplantation
    2.collection of serum creatinin and cystatin C levels after 3,7, 14 days and 3,6 and 12 month after kdiney transplantation
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

glomerular filtration rate (GFR) 1 year posttransplantation (calculation with MDRD (Modification of Diet in Renal Disease) and CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) formula)

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Secondary Outcome

kidney survival,
creatinine,
postoperative dialysis,
Cystatin C
(collection data after 3,7, 14 days and 3,6 and 12 month)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/07/24
  •   100
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Informed consent of the study,
patients > 18 years,
Kidney transplantation in the University Medical Center Frankfurt

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Exclusion Criteria

combined organ transplantations

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik für Allgemein- und Viszeralchirurgie, Goethe Universität
    • Mr.  PD Dr.  Frank  Ulrich 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie, Goethe Universität
    • Ms.  Dr.  Juliane  Liese 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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    • Klinik für Allgemein- und Viszeralchirurgie, Goethe Universität
    • Ms.  Dr.  Juliane  Liese 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Sources of Monetary or Material Support

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    • Allgemein- und Viszeralchirurgie, Goethe Universität Frankfurt
    • Mr.  Prof. Dr.   Wolf Otto  Bechstein 
    • Theodor-Stern-Kai 7
    • 60590  Frankfurt
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.