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

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ClinicalTrials.gov Identifier: NCT01760733
Recruitment Status : Active, not recruiting
First Posted : January 4, 2013
Last Update Posted : December 23, 2016
Sponsor:
Collaborator:
Oslo University Hospital
Information provided by (Responsible Party):
Kristian Heldal, Sykehuset Telemark

Brief Summary:
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 or disease
Quality of Life End Stage Renal Disease End Stage Renal Failure on Dialysis

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 280 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Improved Selection of Elderly (> 65 Years) for Kidney Transplantation
Study Start Date : December 2012
Actual Primary Completion Date : December 2016
Estimated Study Completion Date : December 2020

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Primary Outcome Measures :
  1. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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

Responsible Party: Kristian Heldal, Senior Physician, PhD, Sykehuset Telemark
ClinicalTrials.gov Identifier: NCT01760733     History of Changes
Other Study ID Numbers: STHF 81.25
First Posted: January 4, 2013    Key Record Dates
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