Trial Outcomes & Findings for Improved Selection of Elderly (> 65 Years) for Kidney Transplantation (NCT NCT01760733)

Results Overview

Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to one year post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores are obtained at baseline and every six months while patients were on the waiting list are performed. In addition scores are obtained obtained at two, six and twelve months after transplantation. Comparisons between last score obtained on the waiting list and score at twelve months after transplantation are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the scores at one year post transplant.

Recruitment status

ACTIVE_NOT_RECRUITING

Target enrollment

289 participants

Primary outcome timeframe

Change in health related quality of life from baseline to one year after transplantation

Results posted on

2020-04-24

Participant Flow

All patients 65 years and older who were accepted on the Norwegian kidney transplantation waiting list between January 1st 2013 and November 30th 2016 were invited to participate (n = 437). 289 were included, reasons for exclusion were reluctant to participate ( n = 21), not meeting inclusion criteria (n = 21) and not responding (n = 105).

Participant milestones

Participant milestones
Measure	Patients Accepted for the Transplant Waiting List Patients accepted for the kidney transplantation waiting list at Oslo University Hospital between Jan 1 2013 and Nov 30 2016 were included and followed from time of acceptance and up to 10 years after transplantation
Waiting List STARTED	289
Waiting List COMPLETED	217
Waiting List NOT COMPLETED	72
Transplanted STARTED	217
Transplanted COMPLETED	0
Transplanted NOT COMPLETED	217

Reasons for withdrawal

Reasons for withdrawal
Measure	Patients Accepted for the Transplant Waiting List Patients accepted for the kidney transplantation waiting list at Oslo University Hospital between Jan 1 2013 and Nov 30 2016 were included and followed from time of acceptance and up to 10 years after transplantation
Waiting List Death	18
Waiting List Removed from waiting list	41
Waiting List Not received a transplant yet	13
Transplanted Not reached 10 years post transplant	184
Transplanted Death	26
Transplanted Graft loss	7

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Waiting List n=289 Participants Patients on the waiting list for transplantation
Age, Categorical <=18 years	0 Participants n=289 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=289 Participants
Age, Categorical >=65 years	289 Participants n=289 Participants
Age, Continuous	70.6 years n=289 Participants
Sex: Female, Male Female	93 Participants n=289 Participants
Sex: Female, Male Male	196 Participants n=289 Participants
Region of Enrollment Norway	289 participants n=289 Participants
Health Related Quality of Life scores (KDQOL-SF)	49.9 scores on a scale SF-36 general health STANDARD_DEVIATION 22.3 • n=289 Participants

PRIMARY outcome

Timeframe: Change in health related quality of life from baseline to one year after transplantation

Population: Changes in SF-36 score for the dimension "general health" (GH) of the KDQOL-SF between baseline and one year after transplantation

Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to one year post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores are obtained at baseline and every six months while patients were on the waiting list are performed. In addition scores are obtained obtained at two, six and twelve months after transplantation. Comparisons between last score obtained on the waiting list and score at twelve months after transplantation are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the scores at one year post transplant.

Outcome measures

Outcome measures
Measure	Waitlist n=289 Participants Patients on the waiting list for transplantation	Transplanted n=217 Participants Patients who have received a transplant
Changes in Short-term (One Year) Health Related Quality of Life, Measured by the KDQOL-SF Questionnaire	49.5 score on a scale Standard Deviation 22.3	68 score on a scale Standard Deviation 22

PRIMARY outcome

Timeframe: From baseline to three years post transplant

Quality Adjusted Life Years (QALY) are calculated based on Short Form-6D extracted from the SF-36 part of the KDQOL survey while patients were on the waiting list and after transplantation. QALYs are compared between the waiting list and up to three years after transplantation. Costs will be calculated based on information from the patients records and cost/QALY will be compared for the two periods

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline/last score before transplantation to transplantation/up to ten years post transplant

Patient survival on the waiting list and after transplantation will be calculated and compared using the Kaplan Meier method and a Cox regression analysis with a time dependent variable.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From baseline to three years post transplant

Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparison between last score obtained on the waiting list and the score at three years post transplant is performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at three years post transplant.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From last score before transplantation to ten years post transplant

Longitudinally monitoring of health related quality of life (HRQOL) by the Kidney Disease and Quality of Life Short Form (KDQOL-SF) questionnaire from listing for transplantation and up to three years post transplantation. The KDQOL-SF scores are organized in 18 dimensions and the Scores for each Dimension are reported within the range 0-100, higher scores indicate better Health related quality of life. Scores obtained at baseline and every six months while patients were on the waiting list. In addition, scores are obtained at two, six, twelve months and at three years after transplantation. For this outcome, comparisons between last score obtained on the waiting list and the score at five and ten years post transplant are performed. The results are reported as absolute values and changes from baseline/last score before transplantation and the score at five and ten years post transplant.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From last score before transplantation to three years post transplant

Demographic, medical and transplant characteristics were included in multivariable regression models to analyze any associations between these variables and any change in HRQoL described as KDQOL-SF scores between last score before transplantation and three years post transplantation

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From transplantation and up to ten years post tx

Any associations between pre-transplant HRQoL/comorbidity and post transplant survival will be investigated using multivariable cox regression models.

Outcome measures

Outcome data not reported

Adverse Events

Question 65

Serious events: 48 serious events

Other events: 0 other events

Deaths: 44 deaths

Serious adverse events

Serious adverse events
Measure	Question 65 n=289 participants at risk Patients on the waiting list for transplantation - 5 years post KTx Observational study
Renal and urinary disorders Graft loss	3.2% 7/217 • Number of events 7 • This is an observational study describing HRQoL among elderly Kidney Transplant candidates, longitudinally before and after KTx. No experimental interventions are performed and consequently adverse advents other than death, graft loss and being removed from the waiting list are not collected. Data are reported continuously from the clinicians to the Norwegian Renal Registry and exported to the study database. We search the registry every month and update our study database accordingly. The term serious adverse event describes number of patients who are removed from the transplantation waiting list because of medical reasons and patients with graft loss after transplantation. All cause mortality is reported from both patients on the waiting list and those who have received a transplant.
General disorders Removed from the transplantation wait-list	14.2% 41/289 • Number of events 41 • This is an observational study describing HRQoL among elderly Kidney Transplant candidates, longitudinally before and after KTx. No experimental interventions are performed and consequently adverse advents other than death, graft loss and being removed from the waiting list are not collected. Data are reported continuously from the clinicians to the Norwegian Renal Registry and exported to the study database. We search the registry every month and update our study database accordingly. The term serious adverse event describes number of patients who are removed from the transplantation waiting list because of medical reasons and patients with graft loss after transplantation. All cause mortality is reported from both patients on the waiting list and those who have received a transplant.

Other adverse events

Adverse event data not reported

Additional Information

MD, PhD Kristian Heldal

Telemark Hospital Trust

Phone: +4790018417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place