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Improved Selection of Elderly (> 65 Years) for Kidney Transplantation (QUESTION65)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01760733
First Posted: January 4, 2013
Last Update Posted: December 23, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Kristian Heldal, Sykehuset Telemark
  Purpose
Kidney transplantation has been shown to provide improved survival even in patients older than 70 years of age. The purpose of the study is to determine whether kidney transplantation provides any improvement of health related quality of life (HRQOL) in patients over the age of 65 years. HRQOL wil be monitored using the Kidney Disease and Quality of Life (KDQOL-SF)form. Patients will be recruited at the time of acceptance to the Norwegian transplant wait list and followed every 6 months until transplantation. Thereafter a new form will be completed after 10 weeks postv transplant, 6 months, 1 year, 3 years and 5 years. In addition the study will explore the transplant candidates expectations in a qualitative study design and explore the relationship between pre-transplant comorbidity, HRQOL and survival.

Condition
Quality of Life End Stage Renal Disease End Stage Renal Failure on Dialysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation

Resource links provided by NLM:


Further study details as provided by Kristian Heldal, Sykehuset Telemark:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: Change in HRQOL from baseline to 12 months after kidney transplantation ]
    Longitudinally monitoring of HRQOL from listing for transplantation and up to 5 years post transplantation


Enrollment: 280
Study Start Date: December 2012
Estimated Study Completion Date: December 2020
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients older than 65 years listed for kidney transplantation on the Norwegian transplant wait list
Criteria

Inclusion Criteria:

  • End stage renal disease listed for transplantation
  • Age > 65 years

Exclusion Criteria:

  • Not able to fulfill the HRQOL form
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760733


Locations
Norway
Oslo University Hospital, Rikshospitalet, Section of Nephrology
Oslo, Norway, 0424
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
Investigators
Principal Investigator: Kristian Heldal, MD, PhD Sykehuset Telemark
  More Information

Responsible Party: Kristian Heldal, Senior Physician, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01760733     History of Changes
Other Study ID Numbers: STHF 81.25
First Submitted: December 17, 2012
First Posted: January 4, 2013
Last Update Posted: December 23, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Kidney Failure, Chronic
Renal Insufficiency
Renal Insufficiency, Chronic
Kidney Diseases
Urologic Diseases