Resistive Index Measurements After Kidney Transplantation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof Dr Maarten Naesens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01879124
First received: June 10, 2013
Last updated: June 12, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to evaluate the prognostic performance of intrarenal resistive index in the first years after kidney transplantation on graft function and on patient and graft survival. In addition, the determinants of the intrarenal resistive index, including a detailed analysis of the relation between graft histology and the intrarenal resistive index, will be assessed.


Condition
Kidney Failure

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Correlation Between Renal Vascular Resistive Index, Renal Allograft Histology and Outcome

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Overall renal allograft survival [ Time Frame: 7 years after transplantation ] [ Designated as safety issue: No ]
  • Death-censored graft survival [ Time Frame: 7 years after transplantation ] [ Designated as safety issue: No ]
  • Patient survival [ Time Frame: 7 years after transplantation ] [ Designated as safety issue: No ]
  • Reduction of 50% or more in the eGFR from the value measured at the time of ultrasonography [ Time Frame: 7 years after transplantation ] [ Designated as safety issue: No ]

Enrollment: 346
Study Start Date: March 2004
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Kidney transplant recipients
All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007

Detailed Description:

Since March 2004, and as part of routine clinical practice, protocol renal allograft biopsies are routinely performed at implantation and at 3, 12 and 24 months after transplantation, in all patients who receive a kidney transplant at the University Hospitals Leuven, unless there is a medical contra-indication or patient refusal to undergo this procedure. The biopsies are scheduled using a dedicated Microsoft Access database ("Biopsy Database"), that is maintained on the central servers of the University Hospitals Leuven. Patients who have an unexplained change in renal allograft function, undergo additional clinically indicated indication biopsies. These biopsies are also recorded in the aforementioned Microsoft Access Database.

All clinical data, including pretransplant donor and recipient characteristics, and post-transplant follow-up data are directly stored and maintained in a prospectively collected electronic database (CCL database until 06/2012, transferred to the central KWS database in 2012). This electronic database is the only existing clinical database for these patients, and contains all clinical patient charts. No written records are collected.

All renal allograft biopsies will be rescored by a single renal pathologist according to the most recent Banff classification, blinded for the clinical parameters and timing of the biopsy. These rescoring data are directly entered in the dedicated Microsoft Access database ("Biopsy Database").

Just prior to performing a renal allograft biopsy with ultrasound guidance, and as part of the routine clinical procedure, duplex measurements are performed by the radiologist who will perform the biopsy. The peak systolic velocity (Vmax) and the minimal diastolic velocity (Vmin) are determined in each patient in two to three representative interlobar arteries. The resistive index is calculated as [1 - (V min/V max)]. This procedure is repeated at three different places in the kidney (lower, interpolar and upper pole). These data are directly entered in the central electronic clinical database system (KWS, see above).

All electronic data will be transferred to a SAS database at time of data extraction.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

All de novo renal allograft recipients transplanted at the University Hospitals Leuven between March 2004 and October 2007

Criteria

Inclusion Criteria:

Single kidney transplantation

Exclusion Criteria:

None

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01879124

Locations
Belgium
Universitaire Ziekenhuizen Leuven
Leuven, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Maarten Naesens, MD PhD University Hospitals Leuven
  More Information

No publications provided by Universitaire Ziekenhuizen Leuven

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof Dr Maarten Naesens, Prof. Dr. Maarten Naesens, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01879124     History of Changes
Other Study ID Numbers: KidneyTX-UZLEUVEN-RI
Study First Received: June 10, 2013
Last Updated: June 12, 2013
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 11, 2014