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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2014 by Sykehuset Telemark
Oslo University Hospital
Information provided by (Responsible Party):
Kristian Heldal, Sykehuset Telemark Identifier:
First received: December 17, 2012
Last updated: December 2, 2014
Last verified: December 2014
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.

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 Sykehuset Telemark:

Primary Outcome Measures:
  • Health related quality of life [ Time Frame: Change in HRQOL from baseline to 12 months after kidney transplantation ] [ Designated as safety issue: No ]
    Longitudinally monitoring of HRQOL from listing for transplantation and up to 5 years post transplantation

Estimated Enrollment: 200
Study Start Date: December 2012
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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

Inclusion Criteria:

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

Exclusion Criteria:

  • Not able to fulfill the HRQOL form
  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 identifier: NCT01760733

Contact: Kjersti Lønning, MSm +4723073647

Oslo University Hospital, Rikshospitalet, Section of Nephrology Recruiting
Oslo, Norway, 0424
Contact: Kjersti Lønning, MSm    +4723073647   
Contact: Karsten Midtvedt, MD, PhD    +4723071894   
Principal Investigator: Karsten Midtvedt, MD, PhD         
Sponsors and Collaborators
Sykehuset Telemark
Oslo University Hospital
Principal Investigator: Kristian Heldal, MD, PhD Sykehuset Telemark
  More Information

No publications provided

Responsible Party: Kristian Heldal, Senior Physician, PhD, Sykehuset Telemark Identifier: NCT01760733     History of Changes
Other Study ID Numbers: STHF 81.25
Study First Received: December 17, 2012
Last Updated: December 2, 2014
Health Authority: Norway: Ethics Committee

Additional relevant MeSH terms:
Kidney Failure, Chronic
Kidney Diseases
Renal Insufficiency
Renal Insufficiency, Chronic
Urologic Diseases processed this record on November 27, 2015